Dr D Tudehope assisted in writing the protocol. He independently assessed study methodology, extracted data and collaborated with Dr Mills in writing the results.
Since the early 1970's neonatal jaundice has been treated with phototherapy. Phototherapy causes photoisomerisation of bilirubin into a water-soluble form which can be excreted by the kidney. It effectively decreases the SBR in jaundiced newborn infants and decreases the need for exchange blood transfusion (Maisels 1992). To deliver phototherapy the infant is nursed under halogen or fluorescent lamps and the eyes are covered with a mask to prevent retinal damage. The disadvantages of delivering phototherapy in this way are that it can interfere with parent-child bonding (Fetus & Newborn 1986), and that a displaced eye mask can cause nasal obstruction (Al-Salihi 1975). However, this method of delivering phototherapy (conventional phototherapy) remains widely used.
In the last 10 years new devices for delivering phototherapy have been developed using optical fibres and a light source. In the first, the infant is nursed on a blanket containing optical fibres that delivers light to the back. In the second a cummerbund-like band containing optical fibres is wrapped around the infant's trunk. Both types of device have been reported to be effective in reducing serum bilirubin (vs no treatment), and they have the advantage that infants can be nursed close to their parents, without eye protection (Rosenfeld 1990). Because of the easy mode of administration, fibreoptic phototherapy can more easily be delivered at home, with possible economic advantages.
This systematic review includes data from randomised trials in jaundiced
newborn infants and evaluates the effects of both fibreoptic phototherapy
versus no treatment, and fibreoptic versus conventional phototherapy.
Secondary outcome measures:
• Parent-child bonding
• Nursing staff satisfaction
• Maternal satisfaction
• Cost effectiveness
• Cochrane Controlled Trials Register (Cochrane Library, Disk Issue
3, 2000)
• MEDLINE and EMBASE electronic searches using the terms: "jaundice,
jaundice/neonatal, randomized controlled trial, phototherapy, fiber optics,
infant/newborn", and the textwords "biliblanket, wallaby, phototherapy,
fiber optic, jaundice" (1989 to 2000 inclusive)
• Reference lists from the above, and from review articles
• Personal communication with primary authors from the above to identify
unpublished data
• Proceedings of annual meetings of The European Society for Paediatric
Research and The Society for Pediatric Research: handsearches of abstracts
(1989 to 2000 inclusive)
MANUSCRIPTS IN FOREIGN LANGUAGES
Four studies written in Italian (Pometta 1997,
Romagnoli
1992, Romagnoli 1994 (B), Romagnoli
1994 (W), Romagnoli 1995 (B), Romagnoli
1995 (W)) and one in Portuguese (de Carvalho
1992) have been included. In each case the manuscript was read, and
the data collection form completed, by a health-care researcher fluent
in the relevant language working at the institution of the principal reviewer.
In four of the five cases the primary author was subsequently contacted
to answer further questions.
GESTATIONAL AGE
In all included studies the subjects were newborn infants, less than
28 days of age, with clinical or biochemically-defined jaundice. While
most studies enrolled term infants (>=37 weeks gestational age), nine studies
included only preterm infants. Some studies included both term and preterm
infants and these have been divided and included as separate studies (e.g.
Tan 1994 Term, Tan 1994 Pre) if the author provided sufficient data for
this to be possible. Data from preterm infants have been analysed in a
sub-group as specified in the protocol.
BIRTHWEIGHT
In one study (Ittman 1992), separate birthweight strata were included
and a single summary outcome measure including all infants was not provided.
In this case the data have been separated and included as different studies
(Ittmann 1992 <1250g, Ittmann 1992 >1250g).
HAEMOLYSIS
In the majority of the studies, infants were investigated for haemolysis
and excluded if it was present, or if there was mother-infant blood group
incompatability likely to cause it. In one study haemolysis was not considered,
and in another only Rhesus incompatible infants were excluded. No studies
enrolled only infants with haemolysis, and none including haemolysing infants
reported separate data for this group, making the planned sub-group analysis
impossible.
DIFFERENT COMPARISON GROUPS
Of the 24 included studies, one compared fibreoptic phototherapy with
no treatment and 17 compared fibreoptic with conventional phototherapy.
Seven studies compared combination treatment (fibreoptic and conventional)
with conventional phototherapy and one compared double fibreoptic with
conventional phototherapy. Two studies compared different makes of fibreoptic
device. These different comparisons address different questions about the
efficacy of fibreoptic phototherapy and have therefore been analysed separately.
If a study included data comparing combination or double phototherapy with
conventional phototherapy, as well as fibreoptic versus conventional, the
data have been separated and included as a different study (e.g. Al-Alaiyan
1996 Co, Tan 1997 Double).
DIFFERENT PHOTOTHERAPY TYPES
The studies included various forms of fibreoptic and conventional phototherapy.
Two different fibreoptic devices were used (BiliBlanket and Wallaby phototherapy
system) and where both were included in one study the data have been divided
and included as separate studies (e.g. Romagnoli 1994 B, Romagnoli 1994
W). The manufacturers of these devices specify the irradiance of each device
as 35 and 8-10 microwatts/cm2/nm respectively. Conventional phototherapy
was administered with either halogen or fluorescent lamps emitting white
light, blue light, or a mixture of the two. In order to allow calculation
of meaningful summary effect measures, sub-group analyses by type of fibreoptic
phototherapy device, and by conventional phototherapy lamp colour have
been performed. The need for these analyses was not anticipated at the
time of writing the protocol for this review and these sub-groups have
been specified post-hoc.
PRIMARY OUTCOMES
The primary outcome measure used to express the efficacy of phototherapy
varied widely between studies. Most commonly, some measure of the direct
effect of phototherapy on SBR was reported. This was either expressed in
"absolute" terms (e.g. SBR before and after treatment, change in SBR with
treatment, change in SBR per hour of treatment), or in "relative" terms
(percentage change in SBR after 24 or 48 hours of treatment, percentage
change in SBR per hour or per day of treatment). The effect of phototherapy
on SBR was also expressed indirectly (e.g. duration of phototherapy, use
of additional phototherapy, use of exchange transfusion). The incidence
of kernicterus was not reported in any of the studies. Maternal migraine,
trans-epidermal water loss and mesenteric blood flow were reported as side-effects
and have been included in the meta-analysis. The included studies did not
share a common primary outcome measure, making a meta-analysis including
all studies impossible without individual patient data.
SECONDARY OUTCOMES
No data on the effect of different phototherapy devices on mother-child
bonding were reported in any study. Some studies reported the anecdotal
opinions of staff and parents on the different phototherapy devices, but
none used validated scales so these data have been omitted. No data on
cost-effectiveness were reported in any study.
ADDITIONAL OUTCOMES
A significant rebound in SBR requiring further treatment (defined as
an increase in SBR after cessation of phototherapy to a level above that
for which phototherapy was initially commenced) was commonly reported.
This outcome was not anticipated at the time the protocol was written but
is considered by the authors to be an important one and has therefore been
included (use of repeat phototherapy for rebound jaundice).
ADDITIONAL DATA
Contact has been made with, and further data requested and received
from, 10 of the 19 primary authors (Al-Alaiyan, Costello, Crawshaw, Dani,
Donzelli, Holtrop, Ittman, Maisels, Pezzati and Romagnoli). Efforts continue
to make contact with the remaining nine primary authors.
FIBREOPTIC PHOTOTHERAPY VERSUS NO TREATMENT (Comparison 1)
One study investigated this comparison (Romagnoli
1992). Infants randomised to the fibreoptic group were treated with
the Wallaby phototherapy system and infants randomised to control received
no treatment. In both groups, if the SBR reached pre-specified levels conventional
phototherapy was added/commenced. Infants in the fibreoptic group were
less likely to require conventional phototherapy but this did not reach
statistical significance (RR 0.14, 95%CI 0.01, 2.62). However both the
percentage change in SBR per hour, and the percentage change in SBR after
24 hours of treatment, were significantly greater in the fibreoptic group
(WMD -0.44%, 95%CI -0.67, -0.21 and WMD -10.7%, 95%CI -18.14, -3.26, respectively).
FIBREOPTIC VERSUS CONVENTIONAL PHOTOTHERAPY (Comparison 2)
The majority of the studies investigated this comparison. The summary
effect measures for duration of phototherapy, percentage change in SBR
per hour and percentage change in SBR per day were all affected by heterogeneity.
The use of exchange transfusion in the fibreoptic group was increased but
did not reach statistical significance (RR 1.62, 95%CI 0.38, 6.93). The
use of additional phototherapy in the fibreoptic group was significantly
increased (RR 1.68, 95%CI 1.18, 2.38). The percentage change in SBR after
24 and 48 hours of treatment was greater in the conventional phototherapy
group (WMD 3.59%, 95%CI 1.27, 5.92 and WMD 10.79%, 95%CI 8.33, 13.26 respectively).
The use of repeat phototherapy for rebound jaundice was no different between
the groups (RR 2.33, 95%CI 0.92, 5.91). The risk of mothers developing
migraine during their infant's treatment with phototherapy was not significantly
different between groups (RR 5.59, 95%CI 0.29, 108.39). Trans-epidermal
water loss and mesenteric blood flow velocity after feeding were significantly
higher in infants treated with fibreoptic devices (WMD 17.00 mL/m2/hr,
95%CI 7.26, 26.74 and WMD 0.11 m/s, 95%CI 0.10, 0.12 respectively).
FIBREOPTIC VERSUS CONVENTIONAL PHOTOTHERAPY STRATIFIED BY CONVENTIONAL
PHOTOTHERAPY LAMP COLOUR (Comparisons 3-5)
Conventional phototherapy was stratified post-hoc into white light
only, blue light only or a mixture of the two for this sub-group analysis.
The wavelength of light used was ascertained from the manuscript or from
the author for all studies. Halogen and fluorescent lamps were assumed
to be of equivalent efficacy for a given wavelength of light. Infants receiving
fibreoptic phototherapy were significantly more likely to require additional
phototherapy than those receiving conventional phototherapy with either
blue or white lamps (RR 3.08, 95% CI 1.27, 7.48 and RR 1.48, 95% CI 1.01,
2.18 respectively). Similarly, the percentage change in SBR after 48 hours
of treatment was greater for infants treated with either white or blue
lamps than for fibreoptic phototherapy (WMD 11.72%, 95% CI 8.43, 15.01
and WMD 9.73%, 95% CI 5.92, 13.54 respectively).
FIBREOPTIC VERSUS CONVENTIONAL PHOTOTHERAPY IN PRETERM INFANTS (Comparison
6)
Nine studies included only preterm infants, or contained some preterm
infants and reported results for them separately. Duration of phototherapy
was not significantly different between the groups (WMD 2.00 hours, 95%CI
-3.52, 7.52) and there was no greater use of additional phototherapy in
the fibreoptic group (RR 1.07, 95%CI 0.27, 4.27). Percentage change in
SBR per hour and per day was significantly affected by heterogeneity. The
percentage change in SBR after 24 hours of treatment was not significantly
different between the groups (WMD 1.70%, 95%CI -2.65, 6.05), and the use
of repeat phototherapy for rebound jaundice was no higher in the fibreoptic
group (RR 2.00, 95%CI 0.71, 5.63).
FIBREOPTIC VERSUS CONVENTIONAL PHOTOTHERAPY STRATIFIED BY TYPE OF FIBREOPTIC
DEVICE (Comparisons 7-8)
BiliBlanket was compared with conventional phototherapy in 13 studies.
The data for duration of phototherapy and percentage change in SBR per
hour and per day were affected by heterogeneity. The use of additional
phototherapy was significantly increased in the BiliBlanket group (RR 1.57,
95%CI 1.10, 2.24). The use of exchange transfusion and repeat phototherapy
for rebound jaundice were not significantly different between the groups
(RR 1.62, 95%CI 0.38, 6.93 and RR 1.72, 95%CI 0.70, 4.27 respectively).
However the percentage change in SBR after 24 and 48 hours was significantly
less in the BiliBlanket group (WMD 3.51%, 95%CI 0.76, 6.25 and WMD 8.27%,
95%CI 4.62, 11.92 respectively).
Wallaby phototherapy system was compared with conventional phototherapy system in six studies. The data on percentage change in SBR per hour of treatment were affected by heterogeneity. The use of additional and repeat phototherapy for rebound jaundice was no higher in the Wallaby group (RR 9.00, 95%CI 0.50, 162.90 and RR 5.00, 95%CI 0.25, 101.59 respectively). The duration of phototherapy was significantly longer in the Wallaby group (WMD 22.02 hours, 95%CI 16.55, 27.49). The percentage change in SBR per day and after 48 hours of treatment were both significantly lower in the Wallaby group (WMD 3.37%, 95%CI 1.69, 5.05 and WMD 12.9%, 95%CI 9.56, 16.24 respectively) but percentage change at 24 hours of treatment was no different between the groups (WMD 3.82%, 95%CI -0.56, 8.19).
DOUBLE FIBREOPTIC PHOTOTHERAPY VERSUS CONVENTIONAL PHOTOTHERAPY (Comparison
9)
In the single study (Tan 1997 (Double))
reporting this intervention, the infants randomised to double fibreoptic
treatment were wrapped in two BiliBlankets. There was no difference in
duration of treatment or percentage change in SBR per hour or per day between
the groups (WMD 2.24 hours, 95%CI -10.68, 15.16, WMD -0.04%, 95%CI -0.17,
0.09 and WMD 2.82%, 95%CI -1.84, 7.48 respectively). Infants randomised
to the fibreoptic group had no greater use of repeat phototherapy for rebound
jaundice (RR 1.05, 95%CI 0.07, 16.22).
COMBINATION PHOTOTHERAPY (FIBREOPTIC AND CONVENTIONAL) VERSUS CONVENTIONAL
PHOTOTHERAPY (Comparison 10)
Six studies investigated the use of fibreoptic and conventional devices
combined compared to conventional phototherapy. The data for duration of
phototherapy and percentage change per hour and per day were affected by
heterogeneity. There was a trend to less use of exchange transfusion and
additional phototherapy in the combination group but this did not reach
statistical significance (RR 0.24, 95%CI 0.01, 4.72 and RR 0.11, 95%CI
0.01, 2.02 respectively). There was also a trend to greater percentage
change in SBR at 24 and 48 hours in the combination group (WMD -3.2%, 95%CI
-17.2, 10.8 and WMD -9.2%, 95%CI -25.02, 6.62 respectively). There was
no difference in the use of repeat phototherapy for rebound jaundice between
the groups (RR 1.29, 95%CI 0.85, 1.95).
BILIBLANKET VERSUS WALLABY PHOTOTHERAPY SYSTEM (Comparison 11)
In the two studies directly comparing BiliBlanket and the Wallaby phototherapy
system there are no reported outcomes common to each study, and no additional
data have become available which would enable a meta-analysis to be performed.
In the individual studies George et al (George 1994)
found a significant difference in the absolute change in SBR favouring
BiliBlanket, while Maisels et al (Maisels 1998)
found no significant difference in absolute SBR at 12 or 24 hours, or in
the use of additional or repeat phototherapy for rebound jaundice. Thus,
there is no evidence of a difference in efficacy between the devices.
STRENGTHS AND WEAKNESSES OF THE REVIEW PROCESS
The use of the standard search strategy of the Cochrane Collaboration
has uncovered a large number of trials, many more than anticipated by either
author. The location of a number of separately published abstracts in addition
to the main publication, and the fact that contact has been made with the
majority of the authors, suggests that the list of included studies is
complete. A number of the trials which we detected were published in non-English
journals, suggesting that significant ascertainment bias has been avoided.
Agreement between the authors on both methodological quality of the included
studies and the extracted data was high, and all disagreements were able
to be resolved without reference to a third party.
The included studies reported a variety of outcome measures and unfortunately
no single one was common to all studies. This has been partly overcome
by some authors kindly re-analysing their data in different formats. The
efficacy of any phototherapy device depends upon the irradiance of the
emitted light, its wavelength, and the surface area of the infant's skin
onto which it falls. If these had been the only variables in the included
comparisons of fibreoptic and conventional phototherapy the meta-analysis
would have been straightforward. However the reviewers have had to consider
the following:
• The fibreoptic device used differed between studies. The irradiance
of the Wallaby phototherapy system and BiliBlanket are different (8-10
versus 15-35 microwatts/cm2/nm respectively).
• The irradiance setting of the BiliBlanket was not the same in different
studies.
• Conventional phototherapy varied between studies. Both the lamp colour
and lamp type used were not constant.
• The infants enrolled in the studies varied widely. Some studies enrolled
infants with haemolysis, and phototherapy was instituted at quite different
SBR levels.
This variability of intervention has necessitated the inclusion of two sub-group analyses which were not specified a priori. There is also significant heterogeneity of treatment effect on some outcomes within some comparisons in the meta-analysis. This may be due to some of the factors listed above.
The following conclusions on the efficacy of fibreoptic phototherapy can be drawn from the available data:
1. The Wallaby phototherapy system is more effective at lowering SBR
than no treatment.
2. Fibreoptic phototherapy is less effective at lowering SBR than conventional
phototherapy, except in preterm infants and when two BiliBlankets are used
simultaneously, in which cases fibreoptic phototherapy is equally effective.
The difference in efficacy in term versus preterm infants may reflect the
different proportion of the infant's body surface area in contact with
the fibreoptic device.
3. The addition of a fibreoptic device to conventional phototherapy
(or vice versa) is more effective at lowering SBR than conventional phototherapy
alone.
4. There are no data to suggest superiority of one fibreoptic device
over another.
5. There is no evidence from randomised controlled trials that the
use of fibreoptic phototherapy devices has a more favourable impact on
parent-child bonding or maternal or nurse satisfaction than conventional
treatment.
In the term infant with physiological jaundice (by definition at low risk of requiring exchange transfusion), fibreoptic phototherapy may be a reasonable alternative to conventional treatment. Fibreoptic devices are not as effective at lowering SBR and may thus prolong treatment, but this may be of no consequence in a healthy infant with moderate hyperbilirubinaemia and an intact blood brain barrier. Fibreoptic phototherapy does not necessitate the separation of mother from baby, and even though there is no randomised controlled trial data to prove it, there may be some advantage to this.
In the preterm infant, fibreoptic phototherapy is as effective as conventional phototherapy and the two can be used interchangeably.
In the infant with a high SBR who is at risk for an exchange transfusion, the use of double fibreoptic phototherapy, or the addition of conventional phototherapy to a fibreoptic device, will probably lower SBR faster than conventional phototherapy alone. Although this systematic review has not identified any studies specifically investigating infants with haemolysis, the mode of action of phototherapy is the same in this group, so this recommendation is also probably generalisable to the haemolysing infant.
Future investigators should report relative change in bilirubin as a
direct outcome and ensure that SBR criteria are stated a priori if indirect
outcomes are to be used. Adequate allocation concealment should be ensured
and the irradiance of all phototherapy devices should be measured to allow
comparison with other studies.
| Study | Methods | Participants | Interventions | Outcomes | Notes | Allocation concealment |
| Al-Alaiyan 1996 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term and premature infants, >36 weeks GA, >24 hours of age.
Qualifying SBR 170-300 (direct SBR <25). Haemolysis excluded. Fibreoptic n=15, conventional n=15. |
Fibreoptic: BiliBlanket at 22.34 microwatts/cm2/nm (measured). Conventional: Air-Shields (white) at 11.6 microwatts/cm2/nm (measured). | Duration of phototherapy (no SBR level specified for cessation of phototherapy
therefore not included).
Absolute SBR at beginning and end of treatment. |
Data complete | A |
| Al-Alaiyan 1996 (Co) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term and premature infants, >36 weeks GA, >24 hours of age.
Qualifying SBR 170-300 (direct SBR <25). Haemolysis excluded. Combination n=15, conventional n=15. |
Combination: BiliBlanket at 22.34 microwatts/cm2/nm (measured) below
infant, Air-Shields (white) at 11.6 microwatts/cm2/nm (measured) above.
Conventional: Air-Shields (white) at 11.6 microwatts/cm2/nm. |
Duration of phototherapy (no SBR level specified for cessation of phototherapy
therefore not included).
Absolute SBR at beginning and end of treatment. |
Data complete | A |
| Costello 1995 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Premature infants 27-36 weeks GA.
No investigation for haemolysis. Qualifying SBR 125-300. Birthweight significantly lower in fibreoptic group. Fibreoptic n=20, conventional n=24. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Conventional: white and blue lamps at 8 microwatts/cm2/nm. |
Duration of phototherapy (no SBR level specified for cessation of phototherapy
therefore not included).
Use of exchange transfusion. Use of additional phototherapy. |
Data complete (no SBR data available) | A |
| Crawshaw 1992 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Term infants >37 weeks GA.
Haemolysis excluded. Initiation of phototherapy determined by physician. Fibreoptic n=16, conventional n=18. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Conventional: white lamps. |
Duration of phototherapy.
Use of additional phototherapy. Absolute SBR at 12, 24, 36 & 48 hours. % change in SBR at 0-12, 12-24, 24-36 & 36-48 hrs. |
Unpublished trial. Written data supplied by author August 2000.
Data complete (no SBR data available) |
A |
| Dani 2000 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants 31-36 weeks GA, >3 days of age.
Infants with haemolysis and congenital malformations excluded. Qualifying SBR >220. Fibreoptic n=10, conventional n=10. |
Fibreoptic: BiliBlanket.
Conventional: Drager Photo-Therapie 800 (white). |
Duration of phototherapy.
Absolute change in SBR per hour over treatment period. |
Data complete | A |
| de Carvalho 1992 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants, >2500g, >24 hours of age.
Infant with haemolytic disease, sepsis, respiratory distress, direct SBR >2% or unable to be breast fed during study period excluded. Qualifying SBR >205. Fibreoptic n=17, conventional n=17. |
Fibreoptic: BiliBlanket at 42.6 microwatts/cm2/nm (measured).
Conventional: 5 Daylight and 2 Blue "Interelectric Biliblue" F20T12" BBY (General Electric) at 9.8 microwatts/cm2/nm (measured). |
% reduction in SBR at 8, 16, 24, 32, 40 and 48 hours.
Duration of phototherapy. |
Data complete | A |
| Donzelli 1996 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants <37 weeks GA.
Haemolysis excluded. Qualifying SBR >205.2. Fibreoptic n=71, conventional (white) n=71, conventional (blue) n=71. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (measured).
Conventional (white): Sylvania Daylight (1 bank with 8 white tubes) at 9 microwatts/cm2/nm (measured). Conventional (blue): Philips Special Blue (1 bank with 8 blue tubes) at 27 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. |
Further data awaited | C |
| Gale 1990 | Blinding of randomisation: can't tell
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants >37 weeks GA.
Haemolysis excluded. Qualifying SBR >200 (or lower if rapidly rising). Fibreoptic n=20, conventional n=22. |
Fibreoptic: Wallaby at 7 microwatts/cm2/nm (measured).
Conventional: Air Shields (white and blue) at 7 microwatts/cm2/nm (measured). |
Absolute change in SBR at baseline, 8, 16, 24, 32, 40 & 48 hours | Further data requested | B |
| George 1994 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants, 48-96 hours old, feeding well with normal clinical examination.
Qualifying SBR 171.0-307.8. Haemolysis excluded. BiliBlanket n=26, Wallaby n=27. |
BiliBlanket: 35 microwatts/cm2/nm (set).
Wallaby. |
Absolute SBR at 24 hours after initiation of treatment. | Author unable to be contacted | A |
| Holtrop 1992a | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Term and premature infants >2500g, >24 hours of age.
Haemolysis due to ABO incompatability permitted. Initiation of phototherapy determined by physician. Fibreoptic n=14, conventional n=12. |
Fibreoptic: Wallaby at 8.2 microwatts/cm2/nm (measured).
Conventional: Olympic Bili-lite (1 bank with 4 white and 4 blue tubes) at 9.2 microwatts/cm2/nm (measured). |
Absolute SBR at baseline, 6, 18, 30 & 42 hours.
Absolute decline in SBR/hr in first 18 hours. |
Further data awaited | A |
| Holtrop 1992b | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants, <2500g, weight appropriate for GA, >24 hours
of age.
Infants with Rhesus incompatibility and congenital anomalies excluded. Qualifying SBR 85-256. Combination n=33, conventional n=37. |
Combination: Wallaby at 8.2 microwatts/cm2/nm (measured) with either
Olympic Bili-lite (1 bank with 4 white and 4 blue tubes) at 9.2 microwatts/cm2/nm
or 6 Air Shields halogen lamps at 7 microwatts/cm2/nm.
Conventional: Olympic Bili-lite (1 bank with 8 tubes) at 9.2 microwatts/cm2 or 6 Air Shields halogen lamps at 7 microwatts/cm2/nm. |
Absolute SBR at baseline, 6 and 18 hours.
Absolute decline in SBR after 18 hours of treatment. % decline in SBR after 18 hours of treatment. |
Further data awaited | A |
| Ittman 1992 (<1250g) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants <1250g.
Haemolysis permitted. Initiation of phototherapy determined by physician. Fibreoptic n=10, conventional n=9. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Conventional: Halogen spotlight (blue). |
Duration of phototherapy.
Use of exchange transfusion. Use of additional phototherapy. |
Further data awaited | A |
| Ittman 1992 (>1250g) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants 1250-2500g.
Haemolysis permitted. Initiation of phototherapy determined by physician. Fibreoptic n=11, conventional n=16. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Conventional: Halogen spotlight (blue). |
Duration of phototherapy.
Use of exchange transfusion. Use of additional phototherapy. |
Further data awaited | A |
| Kang 1995 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants <37 weeks GA, <2000g, <1 week of age.
Haemolysis excluded. Qualifying SBR 120-222. Combination n=19, conventional n=23. |
Combination: BiliBlanket at 33-35 microwatts/cm2/nm (measured) and
3 or 4 white/special blue lamps at 7-9 microwatts/cm2/nm (measured).
Conventional: 3 or 4 white/special blue lamps at 7-9 microwatts/cm2/nm (measured). |
Duration of phototherapy.
Use of exchange transfusion. Absolute change in SBR at 8, 16 and 24 hours. |
Author unable to be contacted | C |
| Maisels 1998 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants, <2500g.
Infants with haemolysis, extensive bruising or cephalohaematomata excluded. Qualifying SBR as per nursery protocol. BiliBlanket n=30, Wallaby n=30. |
BiliBlanket: 19.9 microwatts/cm2/nm (measured).
Wallaby: 18.2 microwatts/cm2/nm (measured). |
Absolute SBR at 0, 12 and 24 hours.
Use of additional phototherapy. Use of repeat phototherapy. |
Data complete | A |
| Pezzati 2000 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Healthy, premature infants <37 weeks GA.
Infants with congenital malformations, birth asphyxia, respiratory distress, renal or gastrointestinal pathologies, patent ductus arteriosus, hypo- or hypertension, anaemia and polycythaemia excluded. Haemolysis permitted. Qualifying SBR >171. Fibreoptic n=20, conventional n=19. |
Fibreoptic: BiliBlanket.
Conventional: Drager blue light. |
Duration of phototherapy.
Use of exchange transfusion. Absolute SBR at baseline, 24 hrs and at end of phototherapy. |
Further data awaited | C |
| Pometta 1997 | Blinding of randomisation: can't tell
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants, >2500g, >48 hours old with physiological jaundice.
Infants with haemolysis, blood group incompatability, sepsis, cephalhaematomata, asphyxia excluded. Infants whose mothers took medication during pregnancy excluded. Combination n=25, conventional n=25. |
Combination: Wallaby II at 8 microwatts/cm2/nm (measured) and 6 Air
Shields blue lights at 24 microwatts/cm2/nm (measured).
Conventional: 6 Air Shields blue lights at 24 microwatts/cm2/nm (measured). |
Duration of phototherapy.
Use of additional phototherapy. Absolute SBR at 4 and 16 hrs and at end of phototherapy. Absolute change in SBR at 4 and 16 hours, and at end of phototherapy. Absolute change in SBR/hr over whole period of treatment. % change in bilirubin at 4 and 16 hours, and over whole period of treatment. % change in SBR/hr over whole period of treatment. |
Author unable to be contacted | B |
| Romagnoli 1992 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants.
Infants with birth asphyxia, hypoglycaemia, gastrointerstinal pathology or haemolysis excluded. Infants of mothers with diabetes or who received corticosteroids or barbiturates excluded. Qualifying SBR >205 up to 72 hours, >256 after 72 hours. Fibreoptic n=23, no treatment n=23. |
Fibreoptic: Wallaby at 8-10 microwatts/cm2/nm (set). | Absolute change in SBR at 12 and 24 hour.
% change in SBR at 12 and 24 hours. Use of exchange transfusion. Use of additional phototherapy. |
Data complete | C |
| Romagnoli 1994 (B) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants.
Infants with haemolysis, dehydration or malformations excluded. Infants of mothers with diabetes or who received corticosteroids or barbiturates excluded. Qualifying SBR >239. Fibreoptic (BiliBlanket) n=14, conventional (white) n=14, conventional (blue) n=14, conventional (white and blue) n=14. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Conventional (white): True Light Duro-Test 20 TH 12 TXC at 4-6 microwatts/cm2/nm (set). Convnetional (white and blue): 4 True Light Duro-Test 20 TH 12 TXC and 4 Philips TL 20 W/03T at 8-12 microwatts/cm2/nm (set). Conventional (blue): 8 Philips TL 20 W/52 at 12-14 microwatts/cm2/nm (set). |
% reduction in SBR at 24, 48 and 72 hours. | Data complete | A |
| Romagnoli 1994 (W) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants.
Infants with haemolysis, dehydration or malformations excluded. Infants of mothers with diabetes or who received corticosteroids or barbiturates excluded. Qualifying SBR >239. Fibreoptic (Wallaby) n=14, conventional (white) n=14, conventional (blue) n=14, conventional (white and blue) n=14. |
Fibreoptic: Wallaby at 8-10 microwatts/cm2/nm (set).
Convnetional (white): True Light Duro-Test 20 TH 12 TXC at 4-6 microwatts/cm2/nm (set). Conventional (white and blue): 4 True Light Duro-Test 20 TH 12 TXC and 4 Philips TL 20 W/03T at 8-12 microwatts/cm2/nm (set). Convnetional (blue): 8 Philips TL 20 W/52 at 12-14 microwatts/cm2/nm (set). |
% reduction in SBR at 24, 48 and 72 hours. | Data complete | A |
| Romagnoli 1995 (B) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants.
Infants with birth asphyxia, gastrointerstinal pathology or haemolysis excluded. Infants of mothers with diabetes or who received corticosteroids or barbiturates excluded. Qualifying SBR >239. Fibreoptic (BiliBlanket) n=14, conventional (blue) n=14. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (set).
Convnetional: Blue light (8 Philips TL 20 W/52) at 81 microwatts/cm2/nm (measured). |
Absolute SBR at 24, 48 and 72 hours.
% reduction in SBR at 24, 48 and 72 hours. Use of exchange transfusion. |
Data complete | A |
| Romagnoli 1995 (W) | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants.
Infants with birth asphyxia, gastrointerstinal pathology or haemolysis excluded. Infants of mothers with diabetes or who received corticosteroids or barbiturates excluded. Qualifying SBR >239. Fibreoptic (Wallaby) n=18, conventional (white) n=18, conventional (white and blue) n=18. |
Fibreoptic: Wallaby at 8-10 microwatts/cm2/nm (measured).
Conventional (white and blue): 4 True Light Duro-Test 20 TH 12 TXC and 4 Philips TL 20 W/03T at 44 microwatts/ cm2/nm. Convnetional (white): True Light Duro-Test 20 TH 12 TXC at 6.5 microwatts/cm2/nm (measured). |
Absolute SBR at 24, 48 and 72 hours.
% reduction in SBR at 24, 48 and 72 hours. Use of exchange transfusion. |
Data complete | A |
| Sarici 1999 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Term infants, >2500g.
Infants with haemolysis, contained haemorrhage, infection, congenital malformations excluded. Qualifying SBR >220 up to 72 hours, and >255 after 72 hours. Fibreoptic n=50, conventional n=50. |
Fibreoptic: Wallaby at 9.2 microwatts per cm2/nm (measured).
Conventional: Ohio at 18.4 microwatts/cm2/nm (measured, 5 special blue lamps). |
Duration of phototherapy.
Absolute change in SBR/hr over treatment period. % change in SBR/hr over treatment period. Failure of treatment. |
Author unable to be contacted | C |
| Sarici 2000 | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Term infants, >2500g.
Infants with haemolysis, contained haemorrhage, infection, congenital malformations or elevated direct SBR excluded. Qualifying SBR >255. Combination n=50, conventional n=50. |
Combination: Wallaby at 9.8 microwatts/cm2/nm (measured) and Ohio 5
special blue lamps at 18.7 microwatts/cm2/nm (measured).
Conventional: Ohio 5 special blue lamps at 18.4 microwatts/cm2/nm (measured). |
Duration of phototherapy.
Absolute change in SBR/hr over treatment period. % change in SBR/hr over treatment period. Failure of treatment. |
Author unable to be contacted | C |
| Tan 1994 (Co: Prem) | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Combination n=35, conventional n=35. |
Combination: BiliBlanket at 19.01 microwatts/cm2/nm (measured) and
Phillips Daylight (1 bank with 7 white tubes) at 6.73 microwatts/cm2/nm
(measured).
Conventional: Phillips Daylight (1 bank with 7 tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | C |
| Tan 1994 (Co: Term) | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Healthy term infants.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Combination n=55, conventional n=55. |
Combination: BiliBlanket at 19.01 microwatts/cm2/nm (measured) and
Phillips Daylight (1 bank with 7 white tubes) at 6.73 microwatts/cm2/nm
(measured).
Conventional: Phillips Daylight (1 bank with 7 tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | C |
| Tan 1994 (Prem) | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Premature infants.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Fibreoptic n=35, conventional n=35. |
Fibreoptic: BiliBlanket at 19.01 microwatts/cm2/nm (measured).
Conventional: Phillips Daylight (1 bank with 7 white tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | C |
| Tan 1994 (Term) | Blinding of randomisation: no
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Healthy term infants.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Fibreoptic n=55, conventional n=55. |
Fibreoptic: BiliBlanket at 19.01 microwatts/cm2/nm (measured).
Convnetional: Phillips Daylight (1 bank with 7 white tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | C |
| Tan 1997 (Double) | Blinding of randomisation: can't tell
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants >37 weeks GA.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Double fibreoptic n=42, conventional n=44. |
Double: Two BiliBlankets at 19.01 microwatts/cm2/nm (measured).
Convnetional: Phillips Daylight (1 bank of 7 white tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | B |
| Tan 1997 (Single) | Blinding of randomisation: can't tell
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Term infants >37 weeks GA.
Haemolysis excluded. Qualifying SBR >222 up to 48 hours and >255 after 48 hours. Fibreoptic n=42, conventional n=44. |
Fibreoptic: BiliBlanket at 19.01 microwatts/cm2/nm (measured).
Convnetional: Phillips Daylight (1 bank of 7 white tubes) at 6.73 microwatts/cm2/nm (measured). |
% decline in SBR/day over treatment period.
% decline in SBR/hr over treatment period. Duration of phototherapy. Use of additional phototherapy. |
Further data requested | B |
| van Kaam 1998 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: no Blinding of outcome measurement: can't tell |
Premature infants, <2000g.
Haemolysis excluded. Qualifying SBR determined by age and birthweight from graphs. Fibreoptic n=56, conventional n=68. |
Fibreoptic: BiliBlanket at 35 microwatts/cm2/nm (measured).
Convnetional: White light (4 Phillips TLK 40 W/03) at 16 microwatts/cm2/nm (measured). |
Duration of phototherapy.
Use of exchange transfusion. Use of additional phototherapy. |
Further data requested | A |
| Woodall 1992 | Blinding of randomisation: yes
Blinding of intervention: can't tell but probably impossible Complete follow-up: yes Blinding of outcome measurement: can't tell |
Healthy term infants >37 weeks GA, 48-96 hours of age.
Haemolysis excluded. Qualifying SBR 171-308. Fibreoptic n=7, conventional n=8. |
Fibreoptic: Wallaby at 8 microwatts/cm2/nm (measured).
Convnetional: Aequitron 7100(1 bank of daylight and blue lamps) at 8 microwatts/cm2/nm (measured). |
Duration of phototherapy.
Absolute change in SBR/hr over treatment period. |
Further data requested | A |
| Study | Reason for exclusion |
| Hysmith 1992 | Patients allocated to intervention or control according to physician preference. |
| Rosenfeld 1990 | Patients allocated to intervention or control according to physician preference. |
| Schuman 1992 | Patients allocated to intervention or control according to physician preference and equipment availability. |
Al-Alaiyan S. Fiberoptic, conventional and combination phototherapy for treatment of nonhemolytic hyperbilirubinemia in neonates. Ann Saudi Med 1996;16:633-6.
Al-Alaiyan 1996 (Co) {published and unpublished data}
Al-Alaiyan S. Fiberoptic, conventional and combination phototherapy for treatment of nonhemolytic hyperbilirubinemia in neonates. Ann Saudi Med 1996;16:633-6. (Same study as Al-Alaiyan 1996).
Costello 1995 {published and unpublished data}
Costello SA, Nyikal J, Yu VYH, McCloud P. BiliBlanket phototherapy system versus conventional phototherapy: A randomized controlled trial in preterm infants. J Paediatr Child Hlth 1995;31:11-3.
Crawshaw 1992 {unpublished data only}
Crawshaw A. Bili-Blanket versus conventional phototherapy: a prospective trial. Unpublished trial.
Dani 2000 {published and unpublished data}
Dani C, Martelli E, Reali M, Bertini G, Panin G, Rubaltelli F. Effects of fiberoptic and conventional phototherapy on the skin of premature. J Pediatr 2000 in press.
de Carvalho 1992 {published and unpublished data}
de Carvalho M, Lins M, Goldani M, Lopes J, Ennever J. Comparacao entre fototerapia convencional e de fibra otica [Comparison between conventional and fibreoptic phototherapy]. Jornal de Pediatria 1992;68:289-92.
Donzelli 1996 {published and unpublished data}
*Donzelli GP, Moroni M, Rapisardi G, Agati G, Fusi F. Fibreoptic phototherapy in the management of jaundice in low birthweight infants. Acta Paediatr 1996;85:366-70.
Donzelli GP, Moroni M, Paparo M, Cardellini L, Vecchi C. Phototherapy for neonatal jaundice: a comparative study of fiber optic light and fluorescent lamps. Pediatr Res 1992;32:625A.
Gale 1990 {published data only}
Gale R, Dranitzki Z, Dollberg S, Stevenson DK. A randomized, controlled application of the Wallaby phototherapy system compared with standard phototherapy. J Perinatol 1990:239-42.
George 1994 {published data only}
George P, Lynch M. Ohmeda Bililanket vs Wallaby Phototherapy System for the reduction of bilirubin levels in the home-care setting. Clin Pediatr 1994;33:178-80.
Holtrop 1992a {published data only}
*Holtrop PC, Madison K, Maisels J. A clinical trial of fiberoptic phototherapy vs conventional phototherapy. Amer J Dis Child 1992;146:235-7.
Holtrop PC, Madison K, Maisels MJ. A randomized trial of fiberoptic phototherapy (FP) vs conventional phototherapy (CP). Pediatr Res 1990;27:209A.
Holtrop 1992b {published data only}
*Holtrop PC, Ruedisueli K, Maisels MJ. Double versus single phototherapy in low birthweight newborns. Pediatrics 1992;90:674-7.
Holtrop PC, Ruedisueli K, Regan R, Maisels MJ. Double versus single phototherapy in low birthweight infants. Pediatr Res 1991;29:218A.
Ittman 1992 (<1250g) {published and unpublished data}
Ittman PI, Schumacher RE. Blue light special: randomized trial of fiberoptic phototherapy in preterm infants. Pediatr Res 1992;31:205A.
Ittman 1992 (>1250g) {published and unpublished data}
Ittman PI, Schumacher RE. Blue light special: randomized trial of fiberoptic phototherapy in preterm infants. Pediatr Res 1992;31:205A. (Same study as Ittman 1992 (<1250g)).
Kang 1995 {published data only}
*Kang JH, Shankaran S. Double phototherapy with high irradiance compared with single phototherapy in neonates with hyperbilirubinemia. Am J Perinatol 1995;12:178-80.
Kang JH, Shankaran S. Double phototherapy with high irradiance compared with standard phototherapy. Pediatr Res 1992;31:207A.
Maisels 1998 {published and unpublished data}
Maisels MJ, Kring EA, Klarr J. Comparison of the efficacy of two fiberoptic phototherapy blankets. Pediatr Res 1998;43:183A.
Pezzati 2000 {published and unpublished data}
Pezzati M, Biagiotti R, Vangi V, Lombardi E, Wiechmann L, Rubaltelli F. Changes in mesenteric blood flow response to feeding: conventional versus fiber-optic phototherapy. Pediatrics 2000;105:350-3.
Pometta 1997 {published data only}
Pometta P, Rodono A, Distefano G, Amato M. Fototerapia doppia con fibre ottiche Wallaby versus fototerapia convenzionale. Contributo casistico [Double phototherapy with Wallaby optic fibers versus conventional phototherapy. Case reports]. Pediatr Med Chir 1997;19:187-91.
Romagnoli 1992 {published and unpublished data}
Romagnoli C, Frezza S, De Carolis MP, Zecca E, Papacci E, Tortorolo G. Un nuovo sistema di fototerapia nel trattamento dell'itero neonatale [A new device for phototherapy of neonatal jaundice]. Minerva Pediatr 1992;44:551-4.
Romagnoli 1994 (B) {published and unpublished data}
Romagnoli C, Frezza S, Greco F, Vento G, Papacci P, De Carolis MP, Zecca E, Menonna A, Tortorolo G. Il trattamento fototerapico dell'iperbilirubinemia del neonato a termine: Fibre ottiche o sistemi tradizionali? [Phototherapic treatment of the hyperbilirubinemia of the full-term neonate: Fiberoptic or conventional systems?]. Aggiornamento Pediatrico 1994;45:61-7.
Romagnoli 1994 (W) {published and unpublished data}
Romagnoli C, Frezza S, Greco F, Vento G, Papacci P, De Carolis MP, Zecca E, Menonna A, Tortorolo G. Il trattamento fototerapico dell'iperbilirubinemia del neonato a termine: Fibre ottiche o sistemi tradizionali? [Phototherapic treatment of the hyperbilirubinemia of the full-term neonate: Fiberoptic or conventional systems?]. Aggiornamento Pediatrico 1994;45:61-7. (Same study as Romagnoli 1994 (B)).
Romagnoli 1995 (B) {published and unpublished data}
Romagnoli C, Frezza S, Menonna NM, De Carolis MP, Gallini F, Rizzo V, Tortorolo G. Fototerapia a fibre ottiche o tradizionale nel trattamento dell'iperbilirubinemia neonatale [Fiberoptic phototherapy or conventional phototherapy in the treatment of neonatal hyperbilirubinemia]. Riv Ital Pediatr 1995;21:198-205.
Romagnoli 1995 (W) {published and unpublished data}
Romagnoli C, Frezza S, Menonna NM, De Carolis MP, Gallini F, Rizzo V, Tortorolo G. Fototerapia a fibre ottiche o tradizionale nel trattamento dell'iperbilirubinemia neonatale [Fiberoptic phototherapy or conventional phototherapy in the treatment of neonatal hyperbilirubinemia]. Riv Ital Pediatr 1995;21:198-205. (Same study as Romagnoli 1995 (B)).
Sarici 1999 {published data only}
Sarici SU, Alpay F, Unay B, Ozcan O, Gokcay E. Comparison of the efficacy of conventional special blue light phototherapy and fiberoptic phototherapy in the management of neonatal hyperbilirubinaemia. Acta Paediatr 1999;88:1249-53.
Sarici 2000 {published data only}
Sarici SU. Alpay F, Unay B, Ozcan O, Gokcay E. Double versus single phototherapy in term newborn infants with significant hyperbilirubinemia. J Trop Pediatr 2000;46:36-9.
Tan 1994 (Co: Prem) {published data only}
Tan KL. Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia. J Pediatr 1994;125:607-12.
Tan 1994 (Co: Term) {published data only}
Tan KL. Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia. J Pediatr 1994;125:607-12. (Same study as Tan 1994 (Co: Prem)).
Tan 1994 (Prem) {published data only}
Tan KL. Comparison of the efficacy of fiberoptic and conventional phototherapy for neonatal hyperbilirubinemia. J Pediatr 1994;125:607-12. (Same study as Tan 1994 (Co: Prem)).
Tan 1994 (Term) {published data only}
Tan KL. Comparison of the efficacy of fibreoptic and conventional phototherapy for neonatal hyperbilirubinaemia. J Pediatr 1994;125:607-12. (Same study as Tan 1994 (Co: Prem)).
Tan 1997 (Double) {published data only}
Tan KL. Efficacy of bidirectional fiber-optic phototherapy for neonatal hyperbilirubinemia. Pediatr Res 1997;99:E13.
Tan 1997 (Single) {published data only}
Tan KL. Efficacy of bidirectional fiber-optic phototherapy for neonatal hyperbilirubinemia. Pediatr Res 1997;99:E13. (Same study as Tan 1997 (Double)).
van Kaam 1998 {published data only}
van Kaam AHLC, van Beek RHT, Vergunst-van Keulen JG, van der Heijden J, Lutz-Dettinger N, Hop W, Sauer PJJ. Fibre optic versus conventional phototherapy for hyperbilirubinaemia in preterm infants. Eur J Pediatr 1998;157:132-7.
Woodall 1992 {published data only}
Woodall D, Karas JG. A new light on jaundice. Clin Pediatr 1992;31:353-6.
Hysmith T, Hysmith S, Farmer D. A comparison of fiberoptic vs overhead fluorescent bank methods of phototherapy for the home-care-appropriate preterm infant. J Perinatol 1992;XII:91.
Rosenfeld 1990 {published data only}
Rosenfeld W, Twist P, Concepcion L. A new device for phototherapy treatment of jaundiced infants. J Perinatol 1990;10:243-8.
Schuman 1992 {published data only}
Schuman AJ, Karush G. Fiberoptic vs conventional home phototherapy for neonatal hyperbilirubinemia. Clin Pediatr 1992;31:345-52.
Amato M, Feller CH, Huppi P. Conventional versus fiberoptic phototherapy for treatment of neonatal hyperbilirubinemia. Dev Physiopat Clin 1992;3:61.
de Luca 1991 {published data only}
De Luca G, Mocerino P, Vetrella A. A new phototherapy: the optical fibers phototherapy. In: Proceedings of the Fourth Neonatology Congress of North Italy; 1991 Nov 21-23; Venice. 1991.
Ennever 1991 {published data only}
Ennever JF, de Carvalho M, Lopes JM, Gerdes JS, Polin RA. Bright light is the right light: multicenter trial of a novel phototherapy device. Pediatr Res 1991;29:213A.
Omenaca 1994 {published data only}
Omenaca F, Paredes C, Peszek I, Lain D. A multi-center, open label, controlled, randomized, clinical trial using fiberoptic light for treatment of jaundice in neonates. In: Proceedings of the 39th Annual Japanese Society for Premature and Newborn Medicine; 1994 Oct 28-29; Tokyo. 1994.
* indicates the primary reference for the study
Al-Salihi FL, Curran YP. Airway obstruction by displaced eye mask during phototherapy. Am J Dis Child 1975;129:1362.
Fetus and Newborn Committee, Canadian Pediatric Society. Use of phototherapy for neonatal hyperbilirubinaemia. Can Med Assoc J 1986;134:1237-1245.
Maisels MJ. Jaundice in the newborn. Pediatr Rev 1982;3:305-319.
Maisels MJ. Neonatal jaundice. In: Sinclair JC, Bracken MB, editor(s). Effective Care of the Newborn Infant. Oxford: Oxford University Press, 1992:507-19.
01.02 Use of additional phototherapy
01.03 Change in serum bilirubin concentration over total treatment period (% change/d)
01.04 Change in serum bilirubin concentration over total treatment period (%change/hr)
02.01 Duration of phototherapy (hr)
02.02 Use of exchange transfusion
02.03 Use of additional phototherapy
02.04 Change in serum bilirubin concentration over total treatment period (% change/d)
02.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
02.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
02.07 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
02.08 Use of repeat phototherapy for rebound jaundice
02.10 Trans-epidermal water loss (mL/m2/hr)
02.11 Mesenteric blood flow velocity (m/s)
03.01 Duration of phototherapy (hr)
03.02 Use of additional phototherapy
03.03 Change in serum bilirubin concentration over total treatment period (% change/d)
03.04 Change in serum bilirubin concentration over total treatment period (% change/hr)
03.05 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
03.06 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
03.07 Use of repeat phototherapy for rebound jaundice
04.01 Duration of phototherapy (hr)
04.02 Use of exchange transfusion
04.03 Use of additional phototherapy
04.04 Change in serum bilirubin concentration over total treatment period (% change/d)
04.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
04.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
04.07 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
04.08 Use of repeat phototherapy for rebound jaundice
05.01 Duration of phototherapy (hr)
05.02 Use of exchange transfusion
05.03 Use of additional phototherapy
05.04 Change in serum bilirubin concentration over total treatment period (% change/d)
05.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
05.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
05.07 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
05.08 Use of repeat phototherapy for rebound jaundice
06.01 Duration of phototherapy (hr)
06.02 Use of exchange transfusion
06.03 Use of additional phototherapy
06.04 Change in serum bilirubin concentration over total treatment period (% change/d)
06.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
06.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
06.07 Use of repeat phototherapy for rebound jaundice
07.01 Duration of phototherapy (hr)
07.02 Use of exchange transfusion
07.03 Use of additional phototherapy
07.04 Change in serum bilirubin concentration over total treatment period (% change/d)
07.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
07.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
07.07 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
07.08 Use of repeat phototherapy for rebound jaundice
08.01 Duration of phototherapy (hr)
08.02 Use of additional phototherapy
08.03 Change in serum bilirubin concentration over total treatment period (% change/d)
08.04 Change in serum bilirubin concentration over total treatment period (% change/hr)
08.05 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
08.06 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
08.07 Use of repeat phototherapy for rebound jaundice
09.01 Duration of phototherapy (hr)
09.02 Use of additional phototherapy
09.03 Change in serum bilirubin concentration over total treatment period (% change/d)
09.04 Change in serum bilirubin concentration over total treatment period (% change/hr)
09.05 Use of repeat phototherapy for rebound jaundice
10.01 Duration of phototherapy (hr)
10.02 Use of exchange transfusion
10.03 Use of additional phototherapy
10.04 Change in serum bilirubin concentration over total treatment period (% change/d)
10.05 Change in serum bilirubin concentration over total treatment period (% change/hr)
10.06 Change in serum bilirubin concentration over first 24 hours of treatment (% change/24 hr)
10.07 Change in serum bilirubin concentration over first 48 hours of treatment (% change/48 hr)
10.08 Use of repeat phototherapy for rebound jaundice
11.01 Use of additional phototherapy
11.02 Change in serum bilirubin concentration over total treatment period (% change/hr)
11.03 Use of repeat phototherapy for rebound jaundice