Prophylactic synthetic surfactant for preventing morbidity and mortality in preterm infants.

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

OBJECTIVES: To assess the effect of prophylactic administration of synthetic surfactant 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; publication type, clinical trial), 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 synthetic surfactant administered to high risk preterm newborns at or shortly after birth in order to prevent respiratory distress syndrome and other complications of prematurity.

DATA COLLECTION AND ANALYSIS: Data regarding clinical outcomes including the 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, retinopathy of prematurity (any retinopathy, and retinopathy stages 3-4) mortality to one year of age, and 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: Studies of prophylactic administration of synthetic surfactant note a variable improvement in the respiratory status and a decrease in respiratory distress syndrome in infants who receive prophylactic synthetic surfactant. The meta-analysis supports a decrease in the risk of pneumothorax (typical relative risk 0.67, 95% CI 0.50, 0.90; typical risk difference -0.05, 95% CI -0.09, -0. 02), a decrease in the risk of pulmonary interstitial emphysema (typical relative risk 0.68, 95% CI 0.50, 0.93; typical risk difference -0.06, 95% CI -0.11, -0.01), and a decrease in risk of neonatal mortality (typical relative risk 0.70, 95% CI 0.58, 0.85; typical risk difference -0.07, 95% CI -0.11, -0.03). No differences were seen in the risk of intraventricular hemorrhage, necrotizing enterocolitis, bronchopulmonary dysplasia, retinopathy of prematurity and cerebral palsy. The meta-analysis supports an increase in the risk of patent ductus arteriosus associated with prophylactic synthetic surfactant administration (typical relative risk 1.11, 95% CI 1.00, 1.22; typical risk difference 0.05, 95% CI 0. 00,0.10), and an increase in the risk of pulmonary hemorrhage (typical relative risk 3.28, 95% CI 1.50, 7.16; typical risk difference 0.03, 95% CI 0.01, 0.05).

REVIEWER'S CONCLUSIONS: Prophylactic intratracheal administration of synthetic surfactant to infants judged to be at risk of developing respiratory distress syndrome has been demonstrated to improve clinical outcome. Infants who receive prophylactic synthetic surfactant have a decreased risk of pneumothorax, a decreased risk of pulmonary interstitial emphysema, and a decreased risk of neonatal mortality. Infants who receive prophylactic synthetic surfactant have an increased risk of developing patent ductus arteriosus and pulmonary hemorrhage.