Intravenous in-line filters for preventing morbidity and mortality in neonates
Preterm or sick newborn infants are often fed with nutrients and fluids that are delivered directly into a vein. This intravenous delivery can be associated with infection, toxins released by bacteria, and tiny particles that may be in the fluids, such as rubber and plastic, going into the blood. In adults, placing a filter in the intravenous line has been reported to be effective in reducing such risks and filters are increasingly being recommended for use in newborn infants. The review authors searched the medical literature and identified three eligible studies, which recruited a total of 262 newborns. Septicaemia and illness, deaths or problems with the intravenous catheters were no different with or without a filter. These were small studies that provided limited information. This review is unable to recommend their use due to insufficient evidence.
Infusion therapy carries a risk for catheter-associated septicaemia (Geiss 1992). Infection can originate from the catheter tubing, the ports, at the cannula site or from contaminated infusion fluid. Factors cited as increasing the risk for catheter related infection include type of IV fluid, for example total parenteral nutrition solutions or solutions with high concentrations of dextrose (Pearson 1996). While not all infections lead to septicaemia, immuno-compromised patients such as neonates, are at greater risk, and infection becomes a major problem (Ng 1989). In adult patients, use of the bacterial retention filter lead to fewer clinically significant bacteremias (Quercia 1986).
Contamination of IV administration sets with gram-negative bacteria has been reported to lead to rapid proliferation of endotoxins (Bethune 2001). In adults, endotoxins have been implicated in several serious disease processes, including respiratory distress syndrome (Parsons 1989), septic shock (Glauser 1991), multiple organ failure, endotoxic shock and systemic inflammatory response syndrome (Glauser 1991; Casale 1990; Suffredini 1989a). Cardiovascular changes such as increased heart rate, decreased vascular resistance and depressed left ventricular function (Suffredini 1989b) and increased intestinal permeability (O'Dwyer 1988) have also been reported. Periventricular leukomalacia (PVL) is an ischaemic lesion of the periventricular white matter that is primarily seen in premature neonates (Hill 1992). Animal studies have demonstrated the development of PVL in the brains of newborn kittens following injection of endotoxins (Gilles 1977) and it has been postulated that endotoxins may be involved in the pathogenesis of a proportion of cases of PVL in the human neonate (Volpe 2001). Positively-charged in-line filters are reported to be effective in the retention of endotoxins (Barnett 1996).
Particulate matter may cause localized phlebitis (Marshall 1987). The duration of cannulation has been found to contribute to the development of infusion-related phlebitis (Maki 1991), and this may require the cannula to be replaced. Frequent cannula change is an added cost to treatment and may cause the patient pain and distress (Chee 2002). Several adult studies have shown that IV in-line filtration significantly reduces the incidence (Chee 2002; Roberts 1994) and delays the onset of phlebitis, (Roberts 1994; Allcutt 1983) resulting in extended line survival (Roberts 1994), fewer recannulations (Chee 2002) and lower costs.
Adverse systemic effects of particulate matter including granulomata formation in the lung (Marshall 1987) and ischaemic necrosis, are a common finding in necrotizing enterocolitis (Ballance 1990). Garvan examined IV fluids available in Australia, England, Europe and the United States of America for the presence of particulates. Microscopic analysis found rubber particles, crystals, cellulose fibers, fungal spores, starch granules and a crustacean claw (Garvan 1964). More recent studies found glass fragments from the opening of glass ampoules (Shaw 1985), and particles from rubber stoppers and intravenous equipment (Kirkpatrick 1988). Inorganic elements such as calcium, silicon, aluminium, lead and iron, that may have originated from the manufacture and packaging processes (Backhouse 1987), have also been found. The use of in-line filters in adults has been shown to be effective in the removal of particulates, and particularly effective in the removal of particles caused from drug precipitate such as antibiotics (Ball 2003; Chee 2002; Roberts 1994).
In-line IV filters were conceived and first utilized in the 1960s
for the retention of particulate contamination. Since then, filter systems
have been further refined. In-line IV filters are currently claimed to be
an effective strategy for the removal of bacteria, endotoxins and particulates
associated with intravenous therapy in adults (Ball 2003; Kunac 1999) and have also been cited as leading to favourable patient outcomes such as shortened duration of hospital stays (Koekenberg 1983). They are also increasingly being recommended for use in neonates (Bethune 2001; Kunac 1999).
There are two main IV filter pore sizes. The 0.22 micron filter is
used for aqueous solutions, and the 1.2 micron filter is recommended for
larger molecule solutions such as lipids. The 0.22 micron filter has also
been reported to remove air, microorganisms and particulate matter. In addition,
endotoxin retention is reportedly achieved by using a positively charged
filter membrane; toxic macro-molecules are released by gram-negative bacteria
and are claimed to be effective for up to ninety six hours ( Bethune 2001).
The benefits of using IV in-line filters have been challenged by several authors. The Centre for Disease Control and Prevention recommends the filtration of infusates during manufacture as a more cost-effective and practical way to remove particulates than IV in-line filters (Pearson 1996; Newell 1998). Friedland (Friedland 1985) reported that some solutions caused a reduction in flow rate or clogging of the filter. He also reported that certain drugs such as antibiotics may be retained in the filters causing a reduction in potency. There are no known adverse effects from the use of IV in-line filters. If the filters block, they need to be changed leading to the increased manipulation of the IV administration set creating a potential for the introduction of contamination. However, blocking of the filter is claimed to be indicative of a problem such as microprecipitation that is a potentially harmful source of particulate matter (Bethune 2001). Friedland (Friedland 1985) also argued that filters could not reduce the risk of infection caused by contaminants entering the line below the in-line filter. A study by Newell (Newell 1998) found no difference in the rate of septicaemia between children in an oncology unit who had filters fitted and those who did not. They concluded from their results that the added cost of using IV in-line filters was not warranted.
The aim of this study is to systematically review evidence on the effectiveness of in-line filters on intravenous lines in neonates.
Pre-specified sub-group analysis will be carried out according to:
1. Type of filter (approximate diameter 0.2 micron; 1.2 micron)
2. Gestation : term and preterm (defined as < 37 weeks) or extreme preterm (defined as < 30 weeks gestation)
3. Type of intravenous line (central; peripheral)
4. Type of intravenous fluid (crystalloid solutions, total parenteral nutrition, antibiotics, lipids)
Methodological quality of the studies was judged according to: (1) blinding of randomization, (2) blinding of intervention, (3) completeness of follow-up and (4) blinding of outcome measurement. In addition, allocation concealment was ranked using the Cochrane approach: Grade A: Adequate concealment; Grade B: Uncertain; Grade C: Clearly inadequate concealment; Grade D: Not used.
Methods used to synthesise data:
Statistical analysis followed the procedures of the Cochrane Neonatal
Review Group. Dichotomous data is expressed as relative risk (RR and 95%
confidence intervals (CI)), risk difference (RD with 95% CI) and number needed
to treat (NNT) for dichotomous outcomes. Continuous variables was analysed
using weighted mean differences (WMD) and 95% confidence intervals. The heterogeneity of studies was estimated using an I-squared statistic.
Thomas (Thomas 1989) assessed the effect of in-line filters on duration of cannula patency in 63 neonates requiring IV fluids. Thomas (Thomas 1989) used a 0.2 micron CathivexTM filter that is only recommended for the removal of particulate and air. Similar to the van Lingen (van Lingen 2004) study, the filters in the study group were positioned before the cannulae, except where fluids such as blood, plasma protein fraction, fresh frozen plasma or emulsions were being administered. On these occasions, the filter was positioned upstream of the three way tap used for adding such fluids to the primary infusion line. In the control group, an extension set was substituted for the filter. This was included as it provided an equal number of connections and manipulations in the lines for both groups. The intravenous lines and filters were changed every 24 hours in the control and study groups. Cannula site preparation was limited to swabbing the skin with isopropyl alcohol. Following cannulation, the site was covered with a sterile dressing. No extra cannula site care was performed (such as application of antibiotic cream or spray) during the study. Cannula life was assessed by duration of patency and volume of IV fluid passed by the site. Nursing staff observations of the infusion site were used to subjectively determine the end point. Nursing staff routinely checked and recorded the condition of the IV cannula sites and the volume of fluid delivered every hour. No information was provided on the length of the study period.
Bennion (Bennion 1991) assessed the effect of IV in-line filters on serum gentamycin level results, incidence of necrosed areas at the infiltration site and cost of administration sets with and without an IV in-line filter in 111 neonates. Bennion (Bennion 1991) used a 0.22 micron Pall Posidyne ELD96TM that was used by van Lingen 2004. The intravenous sets were changed every four days in the treatment group and daily in the control group. A record of the administration sets was made each day together with serum gentamycin level results for each baby and any necrosed areas that developed. Serum gentamycin levels were checked on the third dose of the antibiotic. No information was provided on cannula site preparation.
All studies were single centre studies. All three studies used 0.2 micron filters. The Bennion (Bennion 1991) and Thomas (Thomas 1989) studies used peripheral catheters, and the van Lingen 2004 study used central venous (percutaneous and umbilical) catheters to deliver the IV fluids. While all the studies compared the use of in-line filters with no in-line filter, the outcomes that were measured varied.
There were no other identified studies that assessed whether intravenous in-line filters prevent morbidity and mortality in neonates.
In-line intravenous filter vs. no filter
Three studies were identified for this comparison (van Lingen 2004; Bennion 1991; Thomas 1989).
Primary outcomes:
1) Mortality from any cause (Table 01.01):
Mortality was only reported in the van Lingen 2004
study of 88 infants. There were four deaths in the control group and none
in the treatment group; no significant impact on mortality was demonstrated.
RR 0.11 [(95% CI 0.01, 2.00), RD -0.09 (95% CI -0.18, 0.00)].
2) Proven septicaemic infection (positive bacterial or fungal blood culture) (Table 01.02):
Proven septicaemic infection was only reported in the van Lingen 2004 study of 88 infants and there was no statistical difference found.
[RR 0.40 (95% CI 0.14, 1.18), RD -0.14 (95% CI -0.29, 0.01)].
Secondary outcomes:
1) Localised phlebitis (redness, inflammation and tenderness at location of cannula) (Table 01.03):
Localised phlebitis was reported in the van Lingen 2004 study of 88 infants and Bennion 1991
reported the incidence of localised necrosis (undefined) in 111 infants.
Overall, no difference between the treatment and control groups was found.
Summary [RR 1.22 (95% CI 0.40, 3.77), RD 0.01 (95% CI -0.05, 0.08)] .
Thomas 1989 reported the incidence of 'tissuing' (undefined by authors but regarded as infiltration or leaking of fluids into the area surrounding the vein) related to number of cannulations rather than number of neonates and, therefore, could not be included in the above analysis. There were 59 incidences of phlebitis from 81 cannulations in the treatment group (n = 30), compared to 67 incidences of phlebitis from 86 cannulations in the control group (n = 33). There was no difference between the treatment and control groups.
2) Duration of cannula patency:
Two studies reported on duration of cannula patency. In the van Lingen 2004
study, the total duration for the catheters remaining in place for all neonates
in the study group (n=44) was a total of 525 patient days (mean 8.1 days
per neonate). In the control group, the total duration for the catheters
remaining in place for all neonates (n=44) was a total of 493 patient days
(mean 8.8 days per neonate). A difference between the treatment and control
groups was not found.
In the Thomas 1989 study, the median duration of catheter patency in the treatment group was 59 hours compared to 49 hours in the control group. The authors reported a statistical difference between the two groups (log rank test Chi squared = 4.024, p < 0.05) with a median increase in cannula patency of twenty percent in the treatment group compared to the control group.
3) Number of catheters inserted:
Two studies reported on the number of catheters inserted (Thomas 1989; van Lingen 2004). There was no difference between the treatment and control groups. In the van Lingen 2004
study there was a total of 65 IV catheter insertions. These were reported
as 23 percutaneous and 42 umbilical central venous catheter insertions (43
first, 17 second and 5 third) for the neonates in the study group (n = 44).
There were 56 (40 percutaneous and 16 umbilical) catheter insertions (42
first, 12 second and 2 third) for the neonates in the control group (n =
44). For the Thomas 1989 study there was a total
of 81 catheter (peripheral) insertions in the study group (n = 30) compared
to 86 catheter (peripheral) insertions in the control group (n = 33). Standard
deviations were not provided and, therefore, a weighted mean difference could
not be performed.
4) Suspected septicaemic infection (clinical symptoms consistent with septicaemia, but not proven) (Table 01.04):
The van Lingen 2004 study of 88 infants was the only study to report suspected septicaemic infection and found no difference.
[RR 0.57 (95% CI 0.18, 1.81), RD -0.07 (95% CI -0.21, 0.07)].
5) Local thrombosis (cannula insertion site, diagnosed by ultrasound) (Table 01.05):
Local thrombosis was only reported in the van Lingen 2004 study and no significant difference was found.
[RR 0.20 (95% CI 0.01, 4.05), RD -0.05 (95% CI -0.12, 0.03)].
6) Systemic thrombus (diagnosed by ultrasound):
No data available.
7) Proven necrotizing enterocolitis (Bell's stage two or greater) (Table 01.06):
Proven necrotizing enterocolitis (NEC) was only reported in the van Lingen 2004 study and there were no significant differences.
[RR 0.20 (95% CI 0.01, 4.05), RD -0.05 (95% CI -0.12, 0.03)].
8) Suspected necrotizing enterocolitis (clinical symptoms consistent with NEC, but not proven):
No data were available.
9) Periventricular leukomalacia (cystic changes in the periventricular areas):
No data available
10) Neurodevelopment (assessed up to 2 years corrected age, as measured by a validated assessment tool):
No data were available.
11) Financial costs:
For the van Lingen 2004 study, costs
attributable to patients in both control and study groups were calculated
on a 'cost of disposables' basis during a standard eight day stay. Additionally,
the time taken for line change was calculated by 'direct assessment', and
an estimate of the relative nursing costs was built into the analysis. In
the study group, filters and intravenous sets were changed every 96 hours
and in the control group, the intravenous sets were changed daily. The total
cost per neonate in the control group was 85.75 Euro and for the study group
was 37.44 Euro showing a saving of 48.31 Euros per neonate over a period
of eight days.
The Bennion 1991 study reported the average cost of an administration system as approximately 17.28 Pounds per day for the control group compared to 8.84 Pounds per day in the study group (showing a daily saving of 8.44 Pounds in the treatment group). This was calculated by dividing the total cost of the equipment used by the number of cot days occupied by babies in each group. The intravenous sets were changed every 96 hours in the control group and in the control group, the intravenous sets were changed daily.
12) Length of stay in hospital (days):
No data were available.
13) Adverse affects reported in the trials:
Bennion 1991 was the only study that reported
any adverse effects. Precipitate was found to clog the filter and the flow
of intravenous fluids.
There was no data available to be able to perform subgroup analysis on type of filter, gestation, type of intravenous line, type of intravenous fluid.
Study | Methods | Participants | Interventions | Outcomes | Notes | Allocation concealment |
Bennion 1991 | Blinding
of randomisation - no (each baby that required intravenous infusion was entered
into the study, with alternate babies having an in-line filter). Blinding of treatment - no Blinding of outcome - no Complete followup - yes | 111 neonates requiring IV fluids via peripheral venous line. Gestation - 28-37 wks. Birthweight - 1170-3240 gms. No exclusions. | Exp. group - 0.22 micron intravenous in-line filter (N=55). Control group - No filter or placebo. Administration set changed daily in control group and every 96 hours in treatment group. (N=56). | 1. Effect of intravenous in-line filters on gentamycin level results. 2. Incidence of necrosed area at infiltration site. 3. Cost of administration sets when an in-line filter is used, compared to the cost when a filter is not used. 4. Duration of IV in progress 5. Duration of IV infusion in progress | C | |
Thomas 1989 | Blinding of
randomisation - no (each baby that required intravenous infusion was entered
into the study, with alternate babies having an in-line filter). Blinding of treatment - no Blinding of outcome - no Complete followup - yes | 63 neonates requiring IV fluids via peripheral venous line. Mean gestation - 34.13- 34.91wks. Mean birthweight - 2230-2350 gms. No exclusions. | Exp. group - 0.2 micron intravenous filter (N=30) Control group - No filter but extension set substituted for filter. (N=33). Administration sets changed every 24 hours in treatment and control groups. | 1. Duration of cannula patency 2. Extravasation 3. Leaking at infusion site 4. Number of catheter insertions | C | |
van Lingen 2004 | blinding
of randomisation - yes (computer generated randomization and sealed numbered
envelopes were opened on admission of the neonate and neonates allocated
to either study or control group). blinding of treatment - no Blinding of outcome - no complete followup - yes | 88
neonates requiring IV fluids via an umbilical or percutaneous central venous
line. Premature infants with RDS and term infants with asphyxia or pneumonia/
septicaemia were eligible. Gestation - 26.3-42.3 wks. Birthweight 585 - 4100 gms. Ineligible if congenital malformation present and infants <26 weeks gestation. | Exp. group - 0.22 micron intravenous filter (N=44) Control group - No filter or placebo . (N=44) Full blood count on admission Catheter tips cultured after removal. Administration set changed daily in the control group. Administration set changed every 96 hours in treatment group | 1. Phlebitis 2. Extravasation 3. Thrombosis 4. Proven Sepsis: 'characteristic clinical symptoms' +ve blood culture, + abnormal tests, (leucocytosis, leucopenia, granulocytopenia CRP> 10mg/l) 5. Unproven sepsis: 'characteristic clinical symptoms' + negative blood culture +abnormal tests 6. NEC 7. Duration of cannula patency 7. Number of catheter insertions. 8. Duration of catheter insertion Secondary septicaemia | A |
Study | Trial name or title | Participants | Interventions | Outcomes | Starting date | Contact information | Notes |
van den Hoogen 2006 | In-line filters in central venous catheters in a neonatal intensive care unit | 442 neonates requiring IV fluids via a central venous catheter (CVC) | sepsis, nursing time and costs, catheter days and number of catheters used were assessed | Dr. Tannette G. Krediet Dept. of Neonatology, Wilhelmina Children's Hospital University Medical Centre PO Box 85090 3508 AB Urecht, The Netherlands. t.krediet@wkz.azu.nl |
Bennion D, Martin K. In-line filtration. Paediatric Nursing 1991;June:20-21.
Thomas 1989 {published data only}
Thomas PH. In-line terminal filtration of intravenous fluids and its effect on cannula patency in neonates. Proceedings- Guild of Hospital Pharmacy 2004;26:3-10.
van Lingen 2004 {published data only}
van Lingen RA, Baerts W, Marquering AC, Ruijs GJ. The use of in-line intravenous filters in sick newborn infants. Acta Paediatrica 2004;93:658-62.
* van den Hoogen A, Uiterwaal CSPM, Bolenius JFGA, Geraards LJ, Fleer A, Krediet TG. In-line filters in central venous catheters in a neonatal intensive care unit. Correspondence.
* indicates the primary reference for the study
Allcutt DA, Lort D, McCollum CN. Final inline filtration for intravenous infusions: a prospective hospital study. British Journal of Surgery 1983;70:111-13.
Backhouse CM, Ball PR, Booth S, Kelshaw MA, Potter SR, McCollum CN. Particulate contaminants of intravenous medications and infusions. Journal of Pharmacy and Pharmacology 1987;39:241-5.
Ball PA. Intravenous in-line filters: filtering the evidence. Current Opinion in Cinical Nutrition and Metabolic Care 2003;6:319-25.
Ballance WA, Dahms BB, Shenker N, Kliegman RM. Pathology of neonatal necrotizing enterocolitis: a ten year experience. Journal of Pediatrics 1990;117:S6-S13.
Barnett MI, Cosslett AG. Endotoxin retention capabilities of positively charged nylon and positively charged polysulphone membrane intravenous filters. Pharmaceutical Sciences 1996;2:319-20.
Bell MJ, Ternberg JL, Feigin RD, Keating JP, Marshall R, Barton L, Brotherton T. Neonatal necrotizing enterocolitis. Therapeutic decisions based upon clinical staging. Annals of Surgery 1978;187:1-7.
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Comparison or outcome | Studies | Participants | Statistical method | Effect size |
---|---|---|---|---|
01 Favours Filter vs FavoursControl | ||||
01 Mortality | 1 | 88 | RR (fixed), 95% CI | 0.11 [0.01, 2.00] |
02 Proven Septicaemia | 1 | 88 | RR (fixed), 95% CI | 0.40 [0.14, 1.18] |
03 Phlebitis | 2 | 199 | RR (fixed), 95% CI | 1.22 [0.40, 3.77] |
04 Suspected Septicaemia | 1 | 88 | RR (fixed), 95% CI | 0.57 [0.18, 1.81] |
05 Localised Thrombi | 1 | 88 | RR (fixed), 95% CI | 0.20 [0.01, 4.05] |
06 Necrotizing Enterocolitis | 1 | 88 | RR (fixed), 95% CI | 0.20 [0.01, 4.05] |
Marian Showell
New South Wales Pregnancy and newborn Services Network, University of Sydney
QEII Building D02
Sydney
NSW AUSTRALIA
2006
E-mail: marian.showell@bigpond.com.au
The review is published as a Cochrane review in The
Cochrane Library, Issue 2, 2006 (see http://www.thecochranelibrary.com for
information). Cochrane reviews are regularly updated as new evidence emerges
and in response to comments and criticisms, and The Cochrane Library should
be consulted for the most recent version of the Review. |