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. 2000;1998(2):CD001149.
doi: 10.1002/14651858.CD001149.

Synthetic surfactant for respiratory distress syndrome in preterm infants

R F Soll  1
Affiliations

Synthetic surfactant for respiratory distress syndrome in preterm infants

R F Soll. Cochrane Database Syst Rev. 2000.

Abstract

Background: This section is under preparation and will be included in the next issue.

Objectives: To assess the effect of intratracheal administration of synthetic surfactant in premature newborns with established respiratory distress syndrome (RDS).

Search strategy: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactants; limits: age groups, newborn infant; publication types, clinical trial), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants, and journal handsearching in the English language.

Selection criteria: Randomized controlled trials which compared the effect of synthetic surfactant treatment to routine management in the treatment of preterm infants with respiratory distress syndrome.

Data collection and analysis: Data regarding clinical outcome including the incidence of pneumothorax, pulmonary interstitial emphysema, pulmonary hemorrhage, patent ductus arteriosus, necrotizing enterocolitis, apnea of prematurity, intraventricular hemorrhage (any grade, and severe intraventricular hemorrhage), bronchopulmonary dysplasia, neonatal mortality, bronchopulmonary dysplasia or death, retinopathy of prematurity (any retinopathy, and retinopathy greater than Stage 3), mortality at hospital discharge, mortality to one year of age, and cerebral palsy (any, and moderate/severe cerebral palsy) was excerpted from the report of the clinical trials by the reviewer. Data were analyzed according to the standards of the Cochrane Neonatal Review Group.

Main results: Six randomized controlled trials of synthetic surfactant treatment of established respiratory distress syndrome were identified. Five of the studies used Exosurf Neonatal (a synthetic surfactant composed of dipalmitoylphosphatidylcholine, hexadecanol and tyloxapol); one small study utilized a mixture of dipalmitoylphosphatidylcholine (DPPC) and phosphatidylglycerol (PG). Treatment with intratracheal Exosurf Neonatal in premature infants with established respiratory distress syndrome improves pulmonary gas exchange and decreases the requirement for ventilatory support. In individual trials, the use of Exosurf Neonatal resulted in a statistically significant reduction in pneumothorax, patent ductus arteriosus, bronchopulmonary dysplasia (BPD), BPD or death at 28 days, and mortality. Similar results are seen when these large trials of Exosurf Neonatal are analyzed in conjunction with the smaller trial of dry powdered DPPC and phosphatidylglycerol (PG). The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.64, 95% CI 0.55, 0.76, typical risk difference -0.09, 95% CI -0.12,-0.06), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.62, 95% CI 0.54, 0.71, typical risk difference -0.12, 95% CI -0.16, -0.09), a decrease in the risk of patent ductus arteriosus (typical relative risk 0.90, 95% CI 0.84, 0.97; typical risk difference -0.06 95% CI -0.10, -0.02), a decrease in the risk of intraventricular hemorrhage (typical relative risk 0.88, 95% CI 0.77, 0.99; typical risk difference -0.04, 95% CI -0.08, -0.00), a decrease in the risk of bronchopulmonary dysplasia (typical relative risk 0.75, 95% CI 0.61, 0.92; typical risk difference -0.04, 95% CI -0.06, -0.01), a decrease in the risk of neonatal mortality (typical relative risk 0. 73, 95% CI 0.61, 0.88; typical risk difference -0.05, 95% CI -0.07, -0.02), a decrease in the risk of bronchopulmonary dysplasia or death at 28 days (typical relative risk 0.73, 95% CI 0.65, 0.83; typical risk difference -0.06, 95% CI -0.11, -0.05), a decrease in the risk of mortality prior to hospital discharge (typical relative risk 0.79, 95% CI 0.68, 0.92; typical risk difference -0.05, 95% CI -0.07, -0.02) and a decrease in the risk of mortality during the first year of life (typical relative risk 0.80, 95% CI 0.69, 0.94; typical risk difference -0.04, 95% CI -0.07, -0.01). (ABS

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Conflict of interest statement

Dr. R. Soll has acted as a consultant and invited speaker for several of the pharmaceutical companies which manufacture surfactant preparations (Abbott Laboratories, Ross Laboratories, Chiesi Pharmaceuticals, Dey Laboratories, Burroughs Wellcome).

References

References to studies included in this review

Long 1991 {published data only}
    1. Courtney SE, Long W, McMillan A, Walter D, Thompson T, Sauve R, Conway B, Bard H. Double‐blind 1 year follow‐up of 1540 infants with respiratory distress syndrome randomized to rescue treatment with two doses of synthetic surfactant or air in four clinical trials. Journal of Pediatrics 1995;126:543‐52. - PubMed
    1. Long W, Corbet A, Cotton R, Courtney S, McGuiness G, Walter D, Watts J, Smyth J, Bard H, Chernick V, American Exosurf Neonatal Study Group 1, and the Canadian Exosurf Neonatal Study Group. A controlled trial of synthetic surfactant in infants weighing 1250 g or more with respiratory distress syndrome. New England Journal of Medicine 1991;325:1696‐703. - PubMed
    1. Sauve R, Long W, Vincer M, Bard M, Derletri D, Stevenson D, Pauly T, Robertson C. Outcome at 1‐year adjusted age of 957 infants wighing more than 1250 grams with respiratory distress syndrome randomized to receive synthetic surfactant or air placebo. Journal of Pediatrics 1995;126:575‐580. - PubMed
McMillan 1995 {published data only}
    1. Courtney SE, Long W, McMillan A, Walter D, Thompson T, Sauve R, Conway B, Bard H. Double‐blind 1 year follow‐up of 1540 infants with respiratory distress syndrome randomized to rescue treatment with two doses of synthetic surfactant or air in four clinical trials. Journal of Pediatrics 1995;126:543‐52. - PubMed
    1. McMillan D, Chernick V, Finer N, Schiff D, Bard H, Watts J, Krzeski R, Long W and The Canadian Exosurf Neonatal Study Group. Effects of two rescue doses of synthetic surfactant in 344 infants with respiratory distress syndrome weighing 750 to 1249 grams: A double‐blind placebo controlled multicenter Canadian trial. Journal of Pediatrics 1995;126:590‐598. - PubMed
    1. Saigal S Robertson C, Sankaran K, Bingham W, Casiro O, MacMurray B, Whitfield M, Long W. One year outcome in 232 premature infants with birthweights of 750 to 1249 grams and respiratory distress syndrome randomized to rescue treatment with two doses of synthetic surfactant or air placebo. Journal of Pediatrics 1995;126:561‐7. - PubMed
Phibbs 1991 {published data only}
    1. Phibbs RH, Ballard RA, Clements JA, Heilbron DC, Phibbs CS, Schlueter MA Sniderman SH, Tooley WH, Wakeley A. Initial clinical trial of Exosurf, a protein‐free synthetic surfactant, for the prophylaxis and early treatment of hyaline membrane disease. Pediatrics 1991;88:1‐9. - PubMed
Smyth 1995 {published data only}
    1. Casiro O, Bingham W, MacMurray B, Whitfield M, Saigal S, Vincer M, Long W. One year follow‐up of 89 infants with birth weights of 500 to 749 grams and respiratory distress syndrome randomized to two rescue doses of synthetic surfactant or air placebo. Journal of Pediatrics 1995;126:553‐60. - PubMed
    1. Courtney SE, Long W, McMillan A, Walter D, Thompson T, Sauve R, Conway B, Bard H. Double‐blind 1 year follow‐up of 1540 infants with respiratory distress syndrome randomized to rescue treatment with two doses of synthetic surfactant or air in four clinical trials. Journal of Pediatrics 1995;126:543‐52. - PubMed
    1. Smyth J, Allen A, MacMurray B, Peliowski A, Sankaran K, Volbert F, Shukla A, Long W. Canadian Exosurf Neonatal Study Group. Double‐blind, randomized, placebo controlled Canadian multicenter trial of two doses of synthetic surfactant or air placebo in 224 infants weighing 500‐749 grams with respiratory distress syndrome. Journal of Pediatrics 1995;126:581‐9. - PubMed
US Exosurf 1991 {published data only}
    1. Courtney SE, Long W, McMillan A, Walter D, Thompson T, Sauve R, Conway B, Bard H. Double‐blind 1 year follow‐up of 1540 infants with respiratory distress syndrome randomized to rescue treatment with two doses of synthetic surfactant or air in four clinical trials. Journal of Pediatrics 1995;126:543‐52. - PubMed
    1. Gong A, Anday E, Boros S, Bucciarelli R, Burchfield D, Zucker J, Long W. One year follow‐up evaluation of 260 premature infants with respiratory distress syndrome and birthweights of 700 to 1350 grams randomized to 2 rescue doses of synthetic surfactant or air placebo. Journal of Pediatrics 1995;126:568‐74. - PubMed
    1. Long WA, Thompson T, Sundell H, Schumacher R, Volberg F, Guthrie R, American Exosurf Neonatal Study Group 1. Effects of two rescue doses of a synthetic surfactant on mortality rate and survival without bronchopulmonary dysplasia in 700‐ to 1350‐gram infants with respiratory distress syndrome. Journal of Pediatrics 1991;118:595‐605. - PubMed
Wilkinson 1985 {published data only}
    1. Wilkinson AR, Jenkins PA, Jeffrey JA. Two controlled trials of dry artificial surfactant: early effects and later outcome in babies with surfactant deficiency. Lancet 1985;2:287‐291. - PubMed

References to studies excluded from this review

Chu 1967 {published data only}
    1. Chu J, Clements JA, Cotten E, Klaus MH, Sweet AY, Tooley WH. Neonatal pulmonary ischemia. Pediatrics 1967;40 Suppl:709‐82. - PubMed
Robillard 1964 {published data only}
    1. Robillard E, Alarie Y, Dagenais‐Perusse P, Baril E, Guilbeault A. Micro‐aerosol administration of synthetic dipalmitoyl lecithin in the respiratory distress syndrome: A preliminary report. Canadian Medical Association Journal 1964;90:55‐7. - PMC - PubMed

Additional references

Cochrane 1996
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Dechant 1991
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Enhorning 1992
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Jobe 1993
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Raju 1993
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Soll 1992
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Soll 1997a
    1. Soll RF, Morley CJ. Prophylactic surfactant vs treatment with surfactant. Cochrane Database of Systematic Reviews 1998, Issue 1.
Soll 1997b
    1. Soll RF. Natural surfactant extract vs. synthetic surfactant in the treatment of established respiratory distress syndrome. Cochrane Database of Systematic Reviews 1998, Issue 1.
Soll RF 1998
    1. Soll RF: Prophylactic Synthetic Surfactant in Preterm Infants (Cochrane Review). In: The Cochrane Library, Issue 2. Oxford: Update Software; 1998. Update Software; 1998. Updated Quarterly.
Tooley 1987
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Van Houten
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References to other published versions of this review

Soll 1992
    1. Soll RF, McQueen MC. Respiratory distress syndrome. In: Sinclair JC, Bracken MB editor(s). Effective Care of the Newborn Infant. Oxford: Oxford University Press, 1992:325‐58.

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