Two-year follow-up of infants treated for neonatal respiratory distress syndrome with bovine surfactant. Survanta Multidose Study Group.
In 1988 and 1989, a total of 1228 infants were studied in four double-blind, controlled, multidose clinical trials establishing the safety and efficacy of beractant (Survanta intratracheal suspension, Ross Products Division of Abbott Laboratories), a modified bovine lung extract, in prevention and treatment of neonatal respiratory distress syndrome in premature infants. Data on clinical status were collected for surviving infants at hospital discharge and at 6, 12, and 24 months of adjusted age. Significantly fewer beractant-treated infants required supplemental oxygen at discharge (p = 0.036). At 6 months of adjusted age, beractant-treated infants had more wheezing (p = 0.023) than control infants, a reduced need for supplemental oxygen (p = 0.019), and a lower incidence of cerebral palsy (p = 0.020). At 12 months of adjusted age, beractant-treated infants had less wheezing than control infants (p = 0.005), and this finding persisted at 24 months of adjusted age (p = 0.008). No circulating antibodies to the proteins present in beractant were found in serum samples at 6 and 12 months of age. These results suggest that the increased survival rate associated with beractant treatment is followed through 2 years of adjusted age by outcomes equivalent to those of untreated control infants.
D001688:Biological Products; D004311:Double-Blind Method; D005500:Follow-Up Studies; D006801:Humans; D007231:Infant, Newborn; D007234:Infant, Premature; D007235:Infant, Premature, Diseases / Q000188:drug therapy; D011663:Pulmonary Surfactants / Q000627:therapeutic use*; D012127:Respiratory Distress Syndrome, Newborn / Q000188:drug therapy*; D016896:Treatment Outcome
D001688:Biological Products; D011663:Pulmonary Surfactants; C072197:beractant