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. 2000;1997(2):CD000511.
doi: 10.1002/14651858.CD000511.

Prophylactic natural surfactant extract for preventing morbidity and mortality in preterm infants

R F Soll  1
Affiliations

Prophylactic natural surfactant extract for preventing morbidity and mortality 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 prophylactic intratracheal administration of natural surfactant extract in preterm newborns at risk for developing respiratory distress syndrome (RDS).

Search strategy: Searches were made of the Oxford Database of Perinatal Trials, Medline (MeSH terms: pulmonary surfactant; limits: age groups; newborn infants), previous reviews including cross references, abstracts, conference and symposia proceedings, expert informants and journal hand searching in the English language.

Selection criteria: Randomized controlled trials which compared the effect of prophylactic natural surfactant administration (surfactant obtained from human or bovine sources, either modified with additional phospholipids or not) administered to high risk preterm newborns at or shortly after birth in order to prevent respiratory distress syndrome, other complications of prematurity, and mortality.

Data collection and analysis: Data regarding clinical outcomes including incidence of pneumothorax, pulmonary interstitial emphysema, patent ductus arteriosus, necrotizing enterocolitis, intraventricular hemorrhage (any grade and severe intraventricular hemorrhage), bronchopulmonary dysplasia, mortality, bronchopulmonary dysplasia or death, and retinopathy of prematurity were excerpted from the reports of the clinical trials by the reviewer. Data analysis was done in accordance with the standards of the Cochrane Neonatal Review Group.

Main results: All of the included studies note an initial improvement in respiratory status and a decrease in the risk of respiratory distress syndrome in infants who receive prophylactic natural surfactant extract. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.35, 95% CI 0.26, 0.49; typical risk difference -0.15, 95% CI -0.20, -0.11), a decrease in the risk pulmonary interstitial emphysema (typical relative risk 0.46, 95% CI 0.35, 0.60; typical risk difference -0.19, 95% CI -0.25, -0.13), a decrease in the risk of neonatal mortality (typical relative risk 0. 60, 95% CI 0.44, 0.83; typical risk difference -0.07, 95% CI -0.12, -0.03), and a decrease in the risk of bronchopulmonary dysplasia or death (typical relative risk 0.84, 95% CI 0.75, 0.93; typical risk difference -0.10, 95% CI -0.16, -0.04. No differences are reported in the risk of intraventricular hemorrhage, patent ductus arteriosus, necrotizing enterocolitis or retinopathy of prematurity. Few data are available on long-term followup of treated infants.

Reviewer's conclusions: Prophylactic intratracheal administration of natural surfactant extract to infants judged to be at risk of developing respiratory distress syndrome (intubated infants <30 weeks gestation) has been demonstrated to improve clinical outcome. Infants who receive prophylactic natural surfactant extract have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, a decreased risk of mortality, and a decreased risk of bronchopulmonary dysplasia or death.

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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).

Figures

1.1
1.1. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 1 Effect on pneumothorax.
1.2
1.2. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 2 Effect on pulmonary interstitial emphysema.
1.3
1.3. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 3 Effect on patent ductus arteriosus.
1.4
1.4. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 4 Effect on sepsis.
1.5
1.5. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 5 Effect on necrotizing enterocolitis.
1.6
1.6. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 6 Effect on intraventricular hemorrhage.
1.7
1.7. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 7 Effect on severe intraventricular hemorrhage.
1.8
1.8. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 8 Effect on bronchopulmonary dysplasia.
1.9
1.9. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 9 Effect on neonatal mortality.
1.10
1.10. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 10 Effect on mortality prior to hospital discharge.
1.11
1.11. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 11 Effect on BPD or death.
1.12
1.12. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 12 Effect on retinopathy of prematurity.
1.13
1.13. Analysis
Comparison 1 Animal derived surfactant extract vs. control, Outcome 13 Retinopathy of prematurity, stages 2‐4.
See this image and copyright information in PMC

References

References to studies included in this review

Bevilacqua 1996 {published data only}
    1. Bevilacqua G, Parmigiani S, Robertson B. Prophylaxis of respiratory distress syndrome by treatment with modified porcine surfactant at birth: a multicentre prospective randomized trial. Journal of Perinatal Medicine 1996;24:609‐20. - PubMed
Dunn 1991 {published data only}
    1. Dunn M, Shennan A, Possmayer F. Bovine surfactant prophylaxis in neonates less than 30 weeks' gestation: A Randomized controlled trial of prophylaxis versus treatment. Pediatrics 1991;87:377‐386. - PubMed
Enhorning 1985 {published data only}
    1. Enhorning G, Shennan A, Possmayer F, Dunn M, Chen CP, Milligan J. Prevention of neonatal respiratory distress syndrome by tracheal instillation of surfactant: a randomized clinical trial. Pediatrics 1985;76:145‐53. - PubMed
Hoekstra 1991 {published data only}
    1. Hoekstra RE, Jackson JC, Myers TF, Frantz ID, Stern ME, Powers WF, Maurer M, Raye JR, Carrier ST, Gunkel JH, Gold AJ. Improved neonatal survival following multiple doses of bovine surfactant in very premature neonates at risk for respiratory distress syndrome. Pediatrics 1991;88:10‐8. - PubMed
Kendig 1988 {published data only}
    1. Kendig JW, Notter RH, Cox C, Aschner JL, Benn S, Bernstein RM, Hendricks‐Munoz K, Maniscalco WM, Metlay LA, Phelps DL, Sinkin RA, Woo9d BP, Shapiro DL. Surfactant replacement therapy at birth: final analysis of a clinical trial and comparisons with similar trials. Pediatrics 1988;82:756‐62. - PubMed
Kwong 1985 {published data only}
    1. Kwong MS, Egan EA, Notter RH, Shapiro DL. Double‐blind clinical trial of calf lung surfactant extract for the prevention of hyaline membrane disease in extremely premature infants. Pediatrics 1985;76:585‐92. - PubMed
Merritt 1986 {published data only}
    1. Merritt TA, Hallman M, Bloom BT, Berry C, Benirschke K, Sahn D, Key T, Edwards D, Jarvenpaa AL, Pohjavuori M, Kankaanpaa K, Kunnas M, Paatero H, Rapola J, Jaaskelainen J. Prophylactic treatment of very premature infants with human surfactant. New England Journal of Medicine 1986;315:785‐90. - PubMed
Shennan 1989 {published data only}
    1. Shennan A, Dunn M. Surfactant replacement trials ‐ the need to maintain concurrent placebo controls. Pediatric Research 1989;25:231A.
Soll 1990 {published data only}
    1. Soll RF, Hoekstra RE, Fangman JJ, Corbet AJ, Adams JM, James LS, Schulze K, Oh W, Roberts JD, Dorst JP, Dramer SS, Gold AJ, Zola EM, Horbar JD, McAuliffe TL, Lucey JF, Ross Collaborative Surfactant Prevention Study Group. Multicenter trial of single‐dose modified bovine surfactant extract (Survanta) for prevention of respiratory distress syndrome. Pediatrics 1990;85:1092‐102. - PubMed

Additional references

Enhorning 1972
    1. Enhorning G, Robertson B. Lung expansion in the premature rabbit fetus after tracheal disposition of surfactant. Pediatrics 1972;50:58‐66. - PubMed
Jobe 1984
    1. Jobe A, Ikegami M, Jacobs M, Jones S. Surfactant and pulmonary blood flow distributions following treatment of premature lambs with natural surfactant. Journal of Clinical Investigation 1984;73:848‐56. - PMC - PubMed
Nilsson 1978
    1. Nilsson R, Grossman G, Robertson B. Lung surfactant and the pathogenesis of neonatal bronchiolar lesions induced by artificial ventilation. Pediatric Research 1978;12:249‐55. - PubMed
Raju 1993
    1. Raju TN, Langenberg P. Pulmonary hemorrhage and exogenous surfactant. Journal of Pediatrics 1993;123:603‐10. - PubMed
Soll 2001
    1. Soll RF, Morley CJ. Prophylactic versus selective use of surfactant in preventing morbidity and mortality in preterm infants. Cochrane Database of Systematic Reviews 2001, Issue 2. [DOI: 10.1002/14651858.CD000510] - DOI - PubMed
Soll 2010
    1. Soll R, Özek E. Prophylactic protein free synthetic surfactant for preventing morbidity and mortality in preterm infants. Cochrane Database of Systematic Reviews 2010, Issue 2. [DOI: 10.1002/14651858.CD001079.pub2] - DOI - PMC - PubMed

References to other published versions of this review

Soll 1997
    1. Soll RF. Prophylactic natural surfactant extract for preventing morbidity and mortality in preterm infants. Cochrane Database of Systematic Reviews 1997, Issue 4. [DOI: 10.1002/14651858.CD000511] - DOI - PMC - PubMed

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