No new trials were identified as a result of this updated search. The conclusions of the review are unchanged.
Newborn nurseries and neonatal intensive care units often require staff and visitors to wear overgowns with the intention of preventing the spread of infection. It has also been thought that putting on an overgown will remind people to wash their hands, which is of proven importance in preventing infection. A review of the medical literature identified eight clinical trials on gowning in these settings, involving 3811 newborns. Infection rates, death rates, or the length of stay of infants were not significantly affected by wearing gowns. Only two of the trials were considered to be of good quality, and there was variation between trials regarding gowning policies. Gowning did not increase the rate of handwashing. There is no evidence to support the use of gowning by staff to prevent the spread of infection. Based on these studies, gowning may not be a cost effective policy.
Organisms introduced into the nursery may be transmitted to other infants by a variety of routes making cross infection a particular problem (Baltimore 1998). A colonised or infected infant has the potential to impact on the colonisation or infection rates in particular time periods. Handwashing is recognised as the single most effective method of reducing the transmission of microorganisms between patients (Larson 1999) and is an integral part of hospital infection control programs. Other practices, such as various barrier methods, are also used to control cross infection in hospitals. Gowning is one barrier method of infection control frequently used to restrict the transmission of infection (Cloney 1986). It is common practice for attendants and visitors to wear overgowns in some neonatal intensive care nurseries. For attendants, this is to prevent patient-to-patient transmission of microorganisms and infection; for visitors, it is to protect newborns from organisms which they may carry. Although wearing overgowns is believed to increase compliance with hand washing, one non-controlled study has not demonstrated this effect (Donowitz 1987). In recent times, cost considerations have led some institutions to abandon the use of overgowns in newborn nurseries (Thigpen 1991).
Although many centres use overgowns for attendants and visitors as a means of infection control in newborn nurseries and neonatal intensive care units, the benefits and risks of gowning remain unclear.
Review authors independently assessed whether studies met the inclusion criteria, and extracted data. Results were compared and discrepancies resolved by consensus or referral to a third party.
Data from each trial were analysed using the Cochrane Neonatal Group's standard methods which include the use of relative risk for categorical data and mean difference for data measured on a continuous scale. 95% confidence intervals are presented for all measures of treatment effect. Trials which allocated clusters of patients to each intervention were not analysed using the number of clusters as the unit of analysis, as intended in the protocol, but analysed as if the allocation was by individual. This was necessary because none of the authors of these trials used the cluster as the unit of analysis. Analysing cluster trials in this way has the potential to over-estimate the effect of treatment (Mollison 2000). Consequently, for each outcome there is a meta-analysis of all trials and also of two sub-groups where appropriate, one which includes the trials which randomised the individual participant and one which includes the cluster allocated trials. For meta-analysis, we used a fixed effect model.
We assessed heterogeneity between results using the I2 statistic (Higgins 2003). This examined the percentage of total variation across studies due to heterogeneity rather than chance. We used a random effects model where the values of I2 were over 50%, indicating a high level of heterogeneity. For all other meta analyses, we used a fixed effect model.
Three of the studies randomised by individual infants. Each of these was conducted in a well baby, full-term nursery (Forfar 1958; Birenbaum 1990; Rush 1990). In two of these studies, rooming in was practiced and infants spent only short periods of time in the nursery (Birenbaum 1990; Rush 1990) . Methods used in the three studies were similar with staff and visitors in the control arm using gowns and those in the experimental arm not wearing gowns. In both groups, infection control precautions, such as handwashing before entering the nursery and before and after handling infants, were observed.
Five studies used cluster allocation by alternating blocks of time for the gown and no-gown periods, in either neonatal intensive care or special care nurseries (Silverman 1967; Evans 1971; Agbayani 1981; Pelke 1994; Tan 1995). In the gowning time periods, gowns were worn by all staff and visitors on entering the nursery and for all infant contacts. In the no-gown time periods, there were between study variations in how 'gowning' was defined. In the earlier studies (Silverman 1967; Evans 1971; Agbayani 1981), gowns were not worn when entering the nursery but they were worn if the incubator hood was opened or when an infant was being held. In the two later studies (Pelke 1994; Tan 1995), gowns were not used at all during the no-gown periods. In the Tan 1995 trial, gowns were defined as a plastic apron.
Alternate time periods used in each study were two or three-month blocks, and the length of studies varied between eight to 25 months. One study attempted to eliminate exposure effects from one time period to another by excluding infants who were admitted in the last 10 days of each two month interval (Agbayani 1981). Adjustment for seasonal biases was made in a further study where the gowning period was extended for one month at the end of the first 12 months to ensure a different distribution of gowning periods in the second year (Silverman 1967). One study provided evidence of community follow-up to establish if any infections had occurred after hospital discharge (Birenbaum 1990).
Each infant was allocated to the gowning and no-gowning groups according to the gowning policy in place during the month the infant was admitted, and outcomes for that infant were attributed to the gowning policy as allocated on admission.
Evans 1971 and Agbayani 1981 reported nasal and umbilical colonisation rates by day of life for the gown and no-gown groups (Evans 1971 on days 2, 4, 6, 8, 10, 14 and 21 and Agbayani 1981 on days 1, 2, 4, 7, 10, 21 and 28). We chose day four results for the meta-analysis to ensure that colonisation was nosocomial (i.e. acquired more than 48 hours after admission) and to maximise the number included in the sample (i.e. it was not until day 10 when similar days were again used for reporting and by this time, many of the infants had been discharged). Groin swabs were also analysed using day four results (Agbayani 1981).
Effect by visitors and attendants
None of the studies reported on
independent effects of wearing gowns by either visitors or attendants. All of
the included studies focused on comparisons when both the visitors and
attendants wore or did not wear gowns.
Concealment of allocation
There was adequate concealment of
allocation in two of the trials (Birenbaum 1990; Rush 1990), each
randomising the individual patient. One used shuffled sealed envelopes (Birenbaum 1990) and
the second used consecutively numbered sealed envelopes that contained a folded
card with the group allocation (Rush 1990). No information
was provided for the allocation technique used by Forfar 1958, but it is
stated that infants were randomly assigned to one of two full term nurseries.
None of the trials using cluster allocation used randomly allocated periods for
the intervention; all use pre-determined two or three month blocks.
Blinding
Blinding of the intervention was not possible. Blinding of
outcome assessment was reported in only one study (Rush 1990).
Completeness of follow-up
In the Birenbaum 1990 study,
there was no indication of how many infants were randomised on admission to
either the gown or no-gown groups. Infants were excluded if they did not have
nose and umbilical cultures taken within six hours of delivery or if they did
not have cultures taken before discharge. This makes the possibility of
attrition bias likely. Rush
1990 enrolled 234 infants in the no-gown group and 239 infants in the gown
group. Length of stay was the only outcome calculated using these numbers.
Infection and colonisation data were reported on 222 infants and 230 infants
respectively. In the Forfar 1958 trial,
follow-up data are complete for infection but not for colonisation. There were
also incomplete colonisation data in the Evans 1971; Agbayani 1981; and the
Pelke 1994 trials.
Eight studies met the inclusion criteria and reported on 3,811 infants who
were cared for by attendants who wore or did not wear gowns.
PRIMARY
OUTCOMES
Death before discharge (Table 01.01)
The death rate
was reported in all the cluster allocation trials, each conducted in intensive
care settings (Silverman 1967; Evans 1971; Agbayani 1981; Tan 1995; Pelke 1994). None of the
trials found a statistically significant effect on death. The meta-analysis was
confined to four trials (Silverman 1967; Evans 1971; Agbayani 1981; Tan 1995). Overall, not
wearing a gown was associated with a trend towards reduction in death rate,
[typical RR 0.84 (95% CI 0.70, 1.02)]; typical RD -0.03 (95% CI -0.05, 0.00)],
but these results did not reach statistical significance. The death rate as
reported by Pelke 1994
was similar between groups (0.44 per 100 patient days in the no gown periods and
0.51 per 100 patient days in the gown periods), but due to the way in which they
were reported, these data could not be included in the
meta-analysis.
Systemic nosocomial infection (Table 01.02)
Five
cluster allocation trials reported information on systemic infection
(septicaemia, meningitis, necrotizing enterocolitis, pneumonia), (Silverman 1967; Evans 1971; Agbayani 1981; Pelke 1994; Tan 1995). One of these (Silverman 1967),
reported only meningitis or septicaemia confirmed by postmortem examination.
None of the trials found a statistically significant effect on the incidence of
systemic nosocomial infection. The meta-analysis, confined to four trials not
including Pelke 1994, found no significant effect on systemic nosocomial
infection, [typical RR 0.95 (95% CI 0.40, 2.23)]. Substantial heterogeneity was
found in this comparison (I2= 57.1%) so a random effects model ws
used for the meta-analysis. Pelke 1994 also provided
data for systemic infections (no gowning period 1.38 infections per 100 patient
days; gowning period 1.21 infections per 100 patient days); the difference was
not statistically significant. Due to the way in which they were reported, the
data of Pelke 1994 could not be included in the
meta-analysis.
Localised nosocomial infection (Table
01.03)
Four studies were identified that evaluated localised nosocomial
infection. Two were trials that randomised the individual patient (Forfar 1958; Rush 1990). These showed
no statistically significant effect, [typical RR 1.17 (95% CI 0.74, 1.86)]. Two
were cluster allocation trials (Evans 1971; Agbayani 1981). These
also showed no significant effect on localised nosocomial infection, typical RR
1.29 (95% CI 0.84, 2.00). The overall estimate for the four studies showed no
significant effect, [typical RR 1.24 (95% CI 0.90, 1.71)].
SECONDARY OUTCOMES
Colonisation
The methods used to
collect and process swabs were similar, but the days on which swabs were taken
varied between studies. Two of the trials limited their investigation to
staphylococcal carriage (Forfar 1958; Rush 1990) and one to
methicillin resistant Staphylococcus aureus carriage (MRSA) (Tan 1995). In the Tan 1995 study, the site of
colonisation was not noted but carriage rates were similar between groups
(no-gown group 4/1002 MRSA positive swabs, gown group 6/904 MRSA positive
swabs).
Nasal colonisation (Table 01.04)
Nasal colonisation data was
compared in six of the eight included studies. Three trials that randomised the
individual patient (Forfar 1958; Birenbaum 1990; Rush 1990) found no
significant differences in nasal colonisation rates, [typical RR 1.02 (95% CI
0.89, 1.18)]. There was also no significant effect seen in the two cluster
trials (Evans 1971; Agbayani 1981),
typical RR 0.91(95% CI 0.77, 1.07). When the results of all five trials were
combined in an overall meta-analysis, there was no significant effect, [typical
RR 0.98 (95% CI 0.88, 1.09)]. In the Pelke 1994 trial the
number of swabs taken was used as the denominator with no indication of how many
infants were swabbed. There were no significant differences in the rate of
positive cultures between the no-gowning and gowning periods (no-gown group
179/375 positive swabs; gown group 208/351 positive swabs).
Umbilical colonisation (Table 01.05)
Six trials provided data on
umbilical colonisation. Those randomising by individual (Forfar 1958; Birenbaum 1990; Rush 1990) showed no
significant effect on this outcome [typical RR 1.03 (95% CI 0.93, 1.14)].
Results from two of the cluster allocation trials (Agbayani 1981; Evans 1971) also showed
no significant difference on this outcome [typical RR 0.96 (95% CI 0.82, 1.12)].
When results from the five trials were combined, the result was not significant,
[typical RR 1.01 (95% CI 0.93, 1.10)]. The other cluster allocation trial, Pelke 1994, reported
similar proportions of positive cultures among the total cultures taken (no-gown
group 92/213 positive swabs; gown group 86/167 positive swabs).
Eye
colonisation (Table 01.06)
One study using random allocation by
individual (Forfar
1958) collected data on eye colonisation. No significant difference was
found between the no-gowned and gowned groups [RR 0.97 (95% CI 0.90, 1.05)].
Groin colonisation (Table 01.07)
One of the trials that randomised
by individual, reported collected data on groin colonisation (Birenbaum 1990).
Gowning policy did not significantly effect this outcome [RR 1.05 (95% CI 0.69,
1.57)].
Stool colonisation
In one study (Pelke 1994) there was a
significant difference in the rate of stool colonisation between the no-gown
(84/372) and the gown groups (48/346). A total of 718 cultures were taken from
230 infants, so it is unknown how many repeat cultures were taken from each
infant with a positive culture result.
Cost
The cost of wearing gowns was estimated in three of the
trials. Forfar 1958
included an estimate of the annual cost of gowning (nursing time, cost of gown
laundering and maintenance) and calculated that the cost of time alone was
equivalent to employing more than one full time equivalent nurse for one year.
Tan 1995 compared the
cost of gowns used in the no-gowning period with those used in the gowning
period. During the gowning period, the average number of gowns used was 312 per
day compared with 177 per day in the no-gowning periods. Gowns were defined as
plastic aprons and cost Singapore $0.05 each. This resulted in a cost difference
of S$1,696 per annum. Rush
1990 concluded that the projected annual cost savings associated with
discontinuing gowns would be approximately $US 8,000 per annum.
Handwashing
One cluster allocation trial compared handwashing
frequency between the no-gowning and gowning time periods (Pelke 1994). Direct
observation at an infant's bedside three times weekly for 30 minutes was used to
collect data. A sample of 87 contacts were observed in the no-gowning period and
34 infant contacts during the gowning period. The rate of hand wash compliance
was similar in the two groups (no gowning 60%, gowning 62%, p = 0.84).
Length of hospital stay (Table 01.08)
Length of hospital stay in a
well baby nursery was measured in three trials randomising the individual (Forfar 1958; Birenbaum 1990; Rush 1990). In the Rush 1990 study, hospital
stay was similar in both groups, [MD 0.40 days (CI -5.82, 6.62)]. The number of
in-patient days did not differ significantly in either the Forfar 1958 trial (no
gown 9.0 days, gown 8.5 days) or the Birenbaum 1990 trial
(no gown 2.81 days, gown 2.84 days). Standard deviations were unavailable for
these two studies, preventing inclusion of these data in the outcome table.
ADDITIONAL OUTCOMES FOR PRETERM INFANTS
Duration of mechanical
ventilation (Table 01.09)
One cluster allocation trial included results
on the duration of mechanical ventilation (Tan 1995). The number of
ventilator days was similar for infants admitted during the no-gowning and
gowning time periods, [MD 5.00 days, (95% CI -11.09, 21.09)].
Duration of neonatal intensive care nursery stay
Pelke 1994 measured
length of stay in a neonatal nursery environment. The mean length of stay
between the no-gown and gown groups was not statistically different (no-gowning
periods: mean number of days = 15; gowning periods: mean number of days = 20).
Antibiotic use in preterm infants
None of the trials provided data
for this outcome
OTHER OUTCOMES
Nursery traffic
In a cluster
allocation trial, Pelke
1994 used two 15-minute observation periods to monitor the number of people
entering the nursery. The patterns of traffic were identical during the no-gown
and gown periods with an average of 10 entries during each 15-minute observation
period.
Post discharge follow-up
In the Birenbaum 1990 study,
83 from the no-gown group and 81 infants in the gown group were able to be
followed up 4 weeks after discharge. Within this time, one infant from the
no-gowning group was treated for conjunctivitis and one infant from the gowning
group required hospitalisation for a viral infection.
SUBGROUP ANALYSIS
Effect by nursery type
All of the trials that randomised the
individual patient were conducted in well-baby nurseries and all of the cluster
allocation trials were undertaken in neonatal intensive care units. Thus, the
analyses, sub-categories for trials randomising the individual are synonymous
with well-baby nurseries and sub-categories for cluster allocation trials are
synonymous with neonatal intensive care units.
Effect by gestational age at birth
We intended to investigate the
effects of wearing gowns for subgroups of newborn infants by gestational age;
however, none of the trials reported outcomes specifically by gestational age so
this analysis could not be done.
Effect by visitors and
attendants
There were no eligible studies reporting the independent
effect of visitors or attendants wearing gowns on the study outcomes.
Among the five cluster allocation trials there were a number of methodological variations that made comparisons difficult. In one study, colonisation rates were reported as outcomes per swab rather than per infant, leading to non-independence of multiple measures of the same outcome in the same patient. Similarly, the day on which swabs were routinely taken varied between studies. Rates of colonisation tend to increase with length of hospital stay, so comparing data on this outcome was not feasible unless swabs had been collected on the same postnatal day. Other data were reported as a rate per 100 days making it impossible to combine these results with other outcome data to estimate an overall effect. In addition, although techniques are now available for analysing cluster allocated studies, results were all analysed as if allocation was by individual, ignoring the cluster design and creating a potential to over-estimate the intervention effect. However, based on the consistency of findings between studies, the method of analysis is unlikely to have changed the primary results of this review.
There was little evidence in this review of either harm or benefit of overgown use when outcomes such as systemic infection, localised infection or colonisation were compared. The only important outcome that showed a strong trend in either direction was death before discharge, where the trend was towards a lower death rate among infants nursed in the non-gowning periods. The two studies contributing to the trend were conducted over 30 years ago when death rates in neonatal intensive care units were very high (Silverman 1967; Evans 1971). Both of the studies used a cluster design and analysed results as though allocation was by individual, which may have tended to overestimate treatment effect. In addition, overgowns were worn by attendants and visitors whenever incubator lids were open or if the infant was removed from the cot, making it unlikely that gowning could account for the observed differences. In the most recent and largest trial, no deaths were reported in either the gowning or no-gowning periods (Tan 1995). The one result that showed a significant difference when overgowns were worn or not worn by visitors and attendants was stool colonisation, with a reduction during gown periods. This result was flawed by the study methodology, where there was evidence of repeat measures on the same infant.
Other outcomes such as handwashing frequency, length of hospital stay, duration of mechanical ventilation and traffic in and out of the nursery were not significantly affected by overgown use. Based on these results and considering the costs associated with gowning, hospital personnel may wish to review their policies.
Heterogeneity effected one comparison, systemic infection. This may be explained by some of the issues outlined above, or because there was some variation in outcome when the older studies were compared with more recent investigations.
All the NICU studies included in this review used cluster allocation rather than allocating individual patients to the experimental and control groups. Allocation by cluster might be seen as a strength of study design for this question. It mirrors the way the intervention is offered in practice, and minimises contamination of the experimental and control groups. Secondary cases (of colonisation, infection, death) are included in the measure of effect. If a favoured policy is identified in such a study, the application of that result in practice would be to use the favoured policy in all babies, thus mimicking a cluster allocation design. However, future trials which use cluster allocation should use truly random methods for allocating by cluster, and should analyse the data taking into account the clustering of allocation.
The question of gowning in neonatal intensive care settings has not been tested using a randomised controlled design. Future investigations in this area should focus on important outcomes such as death and systemic infection using high quality randomised controlled designs of sufficient size to yield a conclusive result. Future studies that use cluster allocation should use truly random rather than quasi-random methods for allocating by cluster, and should analyse the data using methods which take into account the cluster design.
| Study | Methods | Participants | Interventions | Outcomes | Notes | Allocation concealment |
| Agbayani 1981 | Single centre cluster-allocation trial.
Blinding of randomisation: No. Blinding of intervention: No. Blinding of outcome assessment: Unknown. Completeness of follow-up: |
A total of 724 outborn (123) and inborn (601) term and preterm
infants. A subgroup of 273 newborns who met the following inclusion criteria were swabbed for the presence of colonising bacteria. Inclusion criteria: admitted to the NICU between Monday and Thursday who were less than 12 hours old and who had negative blood cultures on admission. Infants who were enrolled in the last 10 days of each two month interval were excluded. |
No gown: Hands and forearms were washed with povidone-iodine for two minutes. Jewelry was removed from wrists and fingers. Nurses wore scrub gowns. Street clothes were worn by physicians, other staff and visitors. Gown: As for no gown periods but gowns were donned before entering the nursery. In both gown and no gown groups, gowns were worn by anyone holding an infant. Anterior nares, umbilicus and groin were swabbed on admission to the nursery and on days 2,4,7,10,14,21 and 28 only among the subgroup of infants. |
1) Death before discharge 2) Systemic nosocomial infection, defined by documented sepsis, meningitis and necrotising enterocolitis. 3) Localised nosocomial infection, defined as conjunctivitis, pustules and abscesses. 4) Colonisation (prevalence of bacteria from the nares, umbilicus and groin) amongst the subgroup at 7 different time points from day 1 to day 28. |
This trail was analysed as if allocation was by individual. It was unclear how all infections were diagnosed. Pathology results were available for systemic infections but not for localised infections. Death, systemic and localised infection was reported for the whole sample. Colonisation data was available for a subgroup of 273 infants. |
C |
| Birenbaum 1990 | Single centre randomised controlled trial.
Blinding of randomisation: Yes. Blinding of intervention: Blinding of outcome assessment : Completeness of follow-up: |
Drawn from 1218 deliveries with no indication of how many were
randomised. Study outcomes were reported for 202 infants. Inclusion
criteria: (for 202 infants) Admission to a combination of newborn nursery
and rooming in care. Exclusion criteria: Infants with mothers determined to be clinically unwell (e.g. defined by fever chorioamnionitis and premature or prolonged rupture of membranes), infant requiring intensive or intermediate care, infants for whom admission cultures were not obtained within 6 hours of delivery, and infants who did not have all admission and discharge cultures performed. |
No gown: Attendants and visitors washed their hands before entering the nursery or mothers room. Gowns were not worn when handling the infant. Gown: As for no gowns except a gown was worn for all infant related procedures. Routines in the nursery remained unchanged. Four swabs were taken from infants, two within 6 hours of admission (nose and umbilicus) and two on discharge. |
1) Nasal colonisation on admission and on discharge 2) Umbilical colonisation on admission and on discharge Any organic growth was considered to be a positive nose or umbilical culture. |
Strong possibility of post-randomised exclusions (infants who did not have initial cultures within 6 hours of delivery and those who did not have 4 cultures performed). | A |
| Evans 1971 | Single centre cluster-allocation trial.
Blinding of randomisation: No. Blinding of intervention: No Blinding of outcome assessment: Completeness of follow-up: unknown |
604 preterm infants admitted to the premature nursery.
Inclusions: Infants nursed in incubators Exclusions: Infants who were severely ill (no definition provided). |
No gown: Visitors and attendants did not cover their outer clothing
and nor did they wash their hands before entering the room. Nurses wore
the white uniforms used to travel to the hospital. Those handling newborn
infants through ports did not wear gowns but scrubbed for 3 minutes with
an antiseptic soap. When infants were removed from an isolette, or when a
hood was opened, all persons in the room wore a gown. Gown: Attendants and visitors removed their outer jackets, washed their hands for 3 minutes and donned a gown before entering the room. Nurses changed into scrub gowns at the beginning of their shift. Both anterior nares and the umbilicus were swabbed 4 to 5 mornings weekly until the infant was transferred from an incubator to an open crib. |
1) Death 2) Systemic infection (pneumonia, meningitis, sepsis) 3) Localised infection (pyodermia, conjunctivitis and diarrhea) 4) Colonisation of the nares and umbilicus were reported at 7 time points from day 1 to 21 but were tabulated by day of life acquired and by species. No overall prevalence by group was reported. |
This trial was analysed as if allocation was by individual. The study was interrupted in September, during a nongowning period, because of transfer of the nursery to a new building. It was unclear how all infections were diagnosed. Pathology results were available for systemic infections but not for localised infections. |
C |
| Forfar 1958 | Single centre randomised controlled trial.
Blinding of randomisation: Unknown. Blinding of intervention: No Blinding of outcome assessment: Unknown. Completeness of follow-up: Localised infection , yes. Colonisation, no |
167 infants admitted to either of two newborn nurseries without
rooming in facilities. Inclusion criteria: none documented. Exclusion criteria: none documented. |
No gowns: No gowns or masks were worn by attendants or visitors. Gown: Attendants and visitors observed a strict gowning and masking regime before entering the nursery. In addition, a 'personalised' gown, one for each baby was donned over the first gown, when handling that infant. Gowns were changed every 24 hours or when soiled. Staff were common to both nurseries. For each baby, an eye swab was taken on the fourth day, a nasal swab on the eighth day and an umbilical swab at the time of separation of the cord. Swabs were taken from infected lesions if possible. Microbiological examination was limited to staphylococcal positive species. |
1) Localised nosocomial infection, diagnosed clinically . 2) Nasal colonisation 3) Umbilical colonisation 4) Eye colonisation 5) Length of stay 6) Nursing time 7) Cost |
Infections were assessed clinically. If possible, a swab was taken from an infected lesion but pathology results were not reported. | B |
| Pelke 1994 | Single centre cluster-allocation trial:
Blinding of randomisation: No. Allocation was by alternate 2-month gowning and no gowning cycles (4 cycles over a period of 8 months). One entire 4 month period was repeated to eliminate the potential for seasonal variables and outbreaks. Blinding of intervention: No Blinding of outcome assessment: Completeness of follow-up: Unclear. The number of cultures exceeded the number of infants but it was unclear if all infants were swabbed. |
313 term and preterm infants admitted to the Neonatal Intensive Care
Unit Inclusion/exclusion criteria: None documented A subgroup of 230 infants (those who had cultures taken) were studied. |
No gown: Nursing staff wore scrub suits, which were home -laundered
and worn to the hospital from home. Other visitors and staff wore their
street clothes when entering the NICU. Residents were the only group who
continued to wear hospital-laundered scrubs and they wore an over-gown
when leaving the area. Gowns were available for parents to use when
holding their infants but these were not used. Gown: Nursery staff changed into scrub dresses or suits and covered these with a gown if they left the area. Other visitors or staff wore gowns over their street clothes when entering the NICU. Infants had nasopharyngeal (or tracheal aspirate if intubated), umbilical and rectal or stool swab taken weekly. Nursery traffic was monitored by tallying the number of people who entered the NICU during two 15-minute periods per day on two days per week. Handwashing compliance was studied by 30 minutes observation by one infants bedside three times weekly. Bedside areas were rotated each week. |
1) Neonatal mortality 2) Nasopharyngeal colonisation 3) Umbilical colonisation 3) Stool colonisation 4) RSV 5) NEC 6) Length of stay 7) Traffic flow 8) Handwashing compliance |
This trial was analysed as if allocation was by individual. Infection rates and mortality were reported as 'rate per 100 days'. Information about the numerator and denominator were requested but the author could not provide these details. | C |
| Rush 1990 | Single centre randomised controlled trial:
Blinding of randomisation: Yes, by sealed envelope. Blinding of Intervention: No Blinding of outcome: yes Complete follow- up: No, due to culture reports missing or research staff unavailable to abstract data |
473 infants. Sample drawn from 1130 infants consecutively admitted to
a newborn nursery. Inclusions: >2500 grams, at least 37 weeks gestation and Apgar at 5 minutes > 7 at 5 minutes. Exclusions: infants initially admitted to the NICU. |
No gown: No cover gowns were worn by staff or visitors during any infant contact. Gown: Staff and visitors wore cover gowns for all infant contact. In both groups, staff members, parents and visitors continued to be advised to wash their hands carefully before providing patient care. Nasal & umbilical swabs were taken by nursing staff on the 3rd postnatal day or before discharge, whichever was the sooner. |
1) Nasal colonisation 2) Umbilical colonisation 3) Colonisation of nose and umbilicus Clarification was requested and received for whether (i) all staff followed the protocol (ii) how infections were diagnosed and when, (iv) clarification of Table 2 and (v) how cost of gowns was estimated |
A | |
| Silverman 1967 | Single centre cluster-allocation trial:
Blinding of randomisation: No. Allocation was by 12 alternate 2 month periods over a 25 month time frame. At the end of the first year, the standard gowning period was extended for one month to ensure a different distribution of gowning periods in the second year. Blinding of Intervention: No Blinding of outcome: Unknown Complete follow- up: Yes |
745 high risk infants admitted to the special care nursery. Inclusion criteria: birthweight < 2kg, and others with major disorders. Exclusion criteria: infants with diarrhea. | No gown: Outer coats were not removed, nor were hands washed before entering the patients room. Outer coats were removed and hands washed before and after infant contact. In addition, gowns were worn if the incubator hood was open. Gown: Outer jackets were removed, hands were washed and a gown donned before entering the room. Hands were washed before and after any infant contact. |
1) Death 2) Systemic infection (included only infants who had died and had a confirmed diagnosis at postmortem of either meningitis or septicemia. |
This trial was analysed as if allocation was by individual. | C |
| Tan 1995 | Single centre cluster-allocation trial.
Blinding of randomisation: Blinding of Intervention: No Blinding of outcome: Unknown Complete follow- up: Yes |
1906 infants admitted to a neonatal intensive care (212) or special
care nursery (1694). Exclusion criteria: infants who required strict isolation. |
No gown: Hands were washed but no gowning was required before entering the nursery. Aprons were worn by staff during both time periods if soiling was anticipated when infants were being handled. Gown: Health care professionals & visitors washed their hands and donned a plastic apron before entering the nursery. Twice weekly endotracheal aspirates were obtained from intubated infants. Nasal swabs (for MRSA only) were obtained on admission then weekly from day three. |
1) Death 2) Systemic infection 3) Localised infection 3) MRSA colonisation 4) Cost of gowns 5) Device related infections NB. Outcomes were reported separately by special care or intensive care unit |
This trial was analysed as if allocation was by
individual. Clarification sought from author about systemic and localised infections but no information received |
C |
| Study | Reason for exclusion |
| Altimier 1996 | Comparison with historical controls. |
| Haque 1989 | No randomisation. |
| Renaud 1983 | Comparison with historical controls. |
| Williams 1969 | Comparison with historical controls. |
Agbayani M, Rosenfeld W, Evans H, Salazar D, Jhaveri R, Braun J. Evaluation of modified gowning procedures in a neonatal intensive care unit. American Journal of Diseases of Children 1981;135:650-2.
Birenbaum 1990 {published data only}
Birenbaum HJ, Glorioso L, Rosenberger C, Arshad C, Edwards K. Gowning on a postpartum ward fails to decrease colonization in the newborn infant. American Journal of Diseases of Children 1990;144:1031-3.
Evans 1971 {published data only}
Evans HE, Akpata SO, Baki A. Bacteriologic and clinical evaluation of gowning in a premature nursery. Journal of Pediatrics 1971;78:883-6.
Forfar 1958 {published data only}
Forfar JO, MacCabe AF. Masking and gowning in nurseries for the newborn infant. Effect on staphylococcal carriage and infection. British Medical Journal 1958;1:76-9.
Pelke 1994 {published data only}
Pelke S, Ching D, Easa D, Melish ME. Gowning does not affect colonization or infection rates in the neonatal intensive care nursery. Archives of Pediatric and Adolescent Medicine 1994;148:1016-20.
Rush 1990 {published data only}
Rush J, Fiorina-Chiovitti R, Kaufman K, Mitchell A. A randomized controlled trial of a nursery ritual: wearing cover gowns to care for healthy newborns. Birth 1990;17:25-30.
Silverman 1967 {published data only}
Silverman WA, Sinclair JC.. Evaluation of precautions before entering a neonatal unit. Pediatrics 1967;40:900-1.
Tan 1995 {published data only}
Tan SG, Lim SH, Malathi I.. Does routine gowning reduce nosocomial infection and mortality rates in a neonatal nursery? A Singapore experience. International Journal of Nursing Practice 1995;1:52-8.
Altimier LB, Lott JW, McCain G. Research utilization: evaluating the use of cover gowns in a neonatal intensive care unit. Neonatal Intensive Care 1996;Nov/Dec:52-8.
Haque 1989 {published data only}
Haque KN, Chagla AH. Do gowns prevent infection in neonatal intensive care units. Journal of Hospital Infection 1989;14:159-62.
Renaud 1983 {published data only}
Renaud M. Effects of discontiuing cover gowns on a postpartal ward upon cord colonization of the newborn. Journal of Obstetric, Gynecologic, and Neonatal Nursing 1983;12:399-401.
Williams 1969 {published data only}
Williams CPS, Oliver TK. Nursery routines and staphylococcal colonization of the newborn. Pediatrics 1969;44:640-6.
* indicates the primary reference for the study
Baltimore RS. Neonatal nosocomial infections. Seminars in Perinatology 1998;22:25-32.
Barton L, Hodgman JE, Pavlova Z. Causes of death in the extremely low birth weight infant. Pediatrics 1999;103:446-51.
Chathas MK, Paton JB, Fisher DE. Percutaneous central venous catheterization. Three years' experience in a neonatal intensive care unit. American Journal of Diseases of Children 1990;144:1246-50.
Cloney DL, Donowitz LG. Overgown use for infection control in nurseries and neonatal intensive care units. American Journal of Diseases of Children 1986;140:680-3.
Donowitz LG. Handwashing technique in a pediatric intensive care unit. American Journal of Diseases of Children 1987;141:683-5.
Foca M, Jacob K, Whittier S, Della Latta P, Factor S, Rubenstein D et al. Endemic pseudomonas aeruginosa infection in a neonatal intensive care unit. New England Journal of Medicine 2000;343:695-700.
Garner JS, Jarvis WR, Emori TG, Horan TC, Hughes JM. APIC Infection Control and Applied Epidemiology: Principles and Practice. St Louis: Mosby, 1996.
Gaynes RP, Edwards JR, Jarvis WR, Culver DH, Tolson JS, Martone WJ. Nosocomial infections among neonates in high-risk nurseries in the United States. National Nosocomial Infection Surveillance System. Pediatrics 1996;98:357-61.
Larson E. Skin hygiene and infection prevention: more of the same or different approaches? Clinical Infectious Diseases 1999;29:1287-94.
Levy O, Martin S, Eichenwald E, Ganz T, Valore E, Carroll SF et al. Impaired innate immunity in the newborn: newborn neutrophils are deficient in bactericidal/permeability increased protein. Pediatrics 1999;104:1327-33.
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Seaward PG, Hannah ME, Myhr TL, Farine D, Ohlsson A, Wang EE et al. International multicentre PROM study: evaluation of predictors of neonatal infection in infants born to patients with premature rupture of membranes at term. Premature Rupture of the Membranes. American Journal of Obstetrics and Gynecology 1998;179:635-9.
Thigpen JL. Responding to research: realistic use of scrub clothes and cover gowns. Neonatal Network 1991;9:41-4.
Webster J, Faoagali JL, Cartwright D. Elimination of methicillin-resistant Staphylococcus aureus from a neonatal intensive care nursery after handwasing with triclosan. Journal of Paediatrics and Child Health 1994;30:59-64.
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| Comparison or outcome | Studies | Participants | Statistical method | Effect size |
|---|---|---|---|---|
| 01 No Gowns vs Gowns | ||||
| 01 Death before discharge | 4 | 2285 | RR (fixed), 95% CI | 0.84 [0.70, 1.02] |
| 02 Systemic nosocomial infection | 4 | 3979 | RR (random), 95% CI | 0.95 [0.40, 2.23] |
| 03 Localised nosocomial infection | 4 | 1947 | RR (fixed), 95% CI | 1.24 [0.90, 1.71] |
| 04 Nasal colonisation | 5 | 1122 | RR (fixed), 95% CI | 0.98 [0.88, 1.09] |
| 05 Umbilical colonisation | 5 | 1116 | RR (fixed), 95% CI | 1.01 [0.93, 1.10] |
| 06 Eye colonisation | 1 | 159 | RR (fixed), 95% CI | 0.97 [0.90, 1.05] |
| 07 Groin colonisation | 1 | 200 | RR (fixed), 95% CI | 1.05 [0.69, 1.57] |
| 08 Length of hospital stay | 1 | 473 | WMD (fixed), 95% CI | 0.40 [-5.82, 6.62] |
| 09 Duration of mechanical ventilation | 1 | 212 | WMD (fixed), 95% CI | 5.00 [-11.09, 21.09] |
01.01 Death before
discharge
01.01.01 Trials randomising the individual
participant
01.01.02 Trials using cluster allocation
01.02 Systemic nosocomial
infection
01.02.01 Trials randomising the individual
participant
01.02.02 Trials using cluster allocation
01.03 Localised nosocomial
infection
01.03.01 Trials randomising the individual
participant
01.03.02 Trials using cluster allocation
01.04 Nasal
colonisation
01.04.01 Trials randomising the individual
participant
01.04.02 Trials using cluster allocation
01.05 Umbilical
colonisation
01.05.01 Trials randomising the individual
participant
01.05.02 Trials using cluster allocation
01.06 Eye
colonisation
01.06.01 Trials randomising the individual
participant
01.06.02 Trials using cluster allocation
01.07 Groin
colonisation
01.07.01 Trials randomising the individual
participant
01.07.02 Trials using cluster allocation
01.08 Length of hospital
stay
01.08.01 Trials randomising the individual
participant
01.08.02 Trials using cluster allocation
01.09 Duration of mechanical
ventilation
01.09.01 Trials randomising the individual
participant
01.09.02 Trials using cluster allocation
| This review is published as a Cochrane review in The
Cochrane Library, Issue 3, 2006 (see http://www.thecochranelibrary.com for
information). Cochrane reviews are regularly updated as new evidence
emerges and in response to feedback. The Cochrane Library should be
consulted for the most recent version of the
review. |
