Surfactant replacement therapy in respiratory distress syndrome. Meta-analysis of clinical trials of single-dose surfactant extracts

H. M. Hennes, M. B. Lee, A. A. Rimm, D. L. Shapiro

Research output: Contribution to journalArticle

43 Citations (Scopus)

Abstract

Replacement therapy with surfactant extracts in premature infants with respiratory distress syndrome has been evaluated in several clinical trials. The results of individual trials do not provide conclusive evidence that administration of a single dose of surfactant improves morbidity or mortality. Meta-analysis is a statistical method to combine the results of such clinical trials, and combined analysis provides a means to overcome the problem of not being able to detect significant small differences in individual trials due to these small sample sizes. Seven clinical trials (277 patients treated with nonhuman surfactant extract and 263 controls) met the criteria for analysis; five outcome measurements (mortality, patent ductus arteriosus, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia) were selected to estimate the treatment effect. The meta-analysis showed that a single dose of surfactant administered before the first breath or within 15 hours of birth significantly decreased the mortality rate (95% confidence interval= -0.19 to -0.03) and the risk of developing pneumothorax (95% confidence interval= -0.28 to -0.14) in infants with respiratory distress syndrome. Further clinical trials are needed to evaluate other aspects of surfactant replacement therapy in premature infants because inconsistent results were observed among the seven analyzed studies.

Original languageEnglish (US)
Pages (from-to)102-104
Number of pages3
JournalAmerican Journal of Diseases of Children
Volume145
Issue number1
StatePublished - 1991

Fingerprint

Respiratory Therapy
Surface-Active Agents
Meta-Analysis
Clinical Trials
Pneumothorax
Mortality
Confidence Intervals
Newborn Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Patent Ductus Arteriosus
Premature Infants
Individuality
Sample Size
Therapeutics
Parturition
Hemorrhage
Morbidity

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health

Cite this

Surfactant replacement therapy in respiratory distress syndrome. Meta-analysis of clinical trials of single-dose surfactant extracts. / Hennes, H. M.; Lee, M. B.; Rimm, A. A.; Shapiro, D. L.

In: American Journal of Diseases of Children, Vol. 145, No. 1, 1991, p. 102-104.

Research output: Contribution to journalArticle

@article{dbb4c4a07976460daf04f89c0e9f50f2,
title = "Surfactant replacement therapy in respiratory distress syndrome. Meta-analysis of clinical trials of single-dose surfactant extracts",
abstract = "Replacement therapy with surfactant extracts in premature infants with respiratory distress syndrome has been evaluated in several clinical trials. The results of individual trials do not provide conclusive evidence that administration of a single dose of surfactant improves morbidity or mortality. Meta-analysis is a statistical method to combine the results of such clinical trials, and combined analysis provides a means to overcome the problem of not being able to detect significant small differences in individual trials due to these small sample sizes. Seven clinical trials (277 patients treated with nonhuman surfactant extract and 263 controls) met the criteria for analysis; five outcome measurements (mortality, patent ductus arteriosus, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia) were selected to estimate the treatment effect. The meta-analysis showed that a single dose of surfactant administered before the first breath or within 15 hours of birth significantly decreased the mortality rate (95{\%} confidence interval= -0.19 to -0.03) and the risk of developing pneumothorax (95{\%} confidence interval= -0.28 to -0.14) in infants with respiratory distress syndrome. Further clinical trials are needed to evaluate other aspects of surfactant replacement therapy in premature infants because inconsistent results were observed among the seven analyzed studies.",
author = "Hennes, {H. M.} and Lee, {M. B.} and Rimm, {A. A.} and Shapiro, {D. L.}",
year = "1991",
language = "English (US)",
volume = "145",
pages = "102--104",
journal = "JAMA Pediatrics",
issn = "2168-6203",
publisher = "American Medical Association",
number = "1",

}

TY - JOUR

T1 - Surfactant replacement therapy in respiratory distress syndrome. Meta-analysis of clinical trials of single-dose surfactant extracts

AU - Hennes, H. M.

AU - Lee, M. B.

AU - Rimm, A. A.

AU - Shapiro, D. L.

PY - 1991

Y1 - 1991

N2 - Replacement therapy with surfactant extracts in premature infants with respiratory distress syndrome has been evaluated in several clinical trials. The results of individual trials do not provide conclusive evidence that administration of a single dose of surfactant improves morbidity or mortality. Meta-analysis is a statistical method to combine the results of such clinical trials, and combined analysis provides a means to overcome the problem of not being able to detect significant small differences in individual trials due to these small sample sizes. Seven clinical trials (277 patients treated with nonhuman surfactant extract and 263 controls) met the criteria for analysis; five outcome measurements (mortality, patent ductus arteriosus, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia) were selected to estimate the treatment effect. The meta-analysis showed that a single dose of surfactant administered before the first breath or within 15 hours of birth significantly decreased the mortality rate (95% confidence interval= -0.19 to -0.03) and the risk of developing pneumothorax (95% confidence interval= -0.28 to -0.14) in infants with respiratory distress syndrome. Further clinical trials are needed to evaluate other aspects of surfactant replacement therapy in premature infants because inconsistent results were observed among the seven analyzed studies.

AB - Replacement therapy with surfactant extracts in premature infants with respiratory distress syndrome has been evaluated in several clinical trials. The results of individual trials do not provide conclusive evidence that administration of a single dose of surfactant improves morbidity or mortality. Meta-analysis is a statistical method to combine the results of such clinical trials, and combined analysis provides a means to overcome the problem of not being able to detect significant small differences in individual trials due to these small sample sizes. Seven clinical trials (277 patients treated with nonhuman surfactant extract and 263 controls) met the criteria for analysis; five outcome measurements (mortality, patent ductus arteriosus, pneumothorax, intraventricular hemorrhage, and bronchopulmonary dysplasia) were selected to estimate the treatment effect. The meta-analysis showed that a single dose of surfactant administered before the first breath or within 15 hours of birth significantly decreased the mortality rate (95% confidence interval= -0.19 to -0.03) and the risk of developing pneumothorax (95% confidence interval= -0.28 to -0.14) in infants with respiratory distress syndrome. Further clinical trials are needed to evaluate other aspects of surfactant replacement therapy in premature infants because inconsistent results were observed among the seven analyzed studies.

UR - http://www.scopus.com/inward/record.url?scp=0025967063&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=0025967063&partnerID=8YFLogxK

M3 - Article

C2 - 1824667

AN - SCOPUS:0025967063

VL - 145

SP - 102

EP - 104

JO - JAMA Pediatrics

JF - JAMA Pediatrics

SN - 2168-6203

IS - 1

ER -