2-YEAR FOLLOW-UP OF INFANTS TREATED FOR NEONATAL RESPIRATORY-DISTRESSSYNDROME WITH BOVINE SURFACTANT

In 1988 and 1989, a total of 1228 infants were studied in four double- blind, controlled, multidose clinical trials establishing the safety a nd efficacy of beractant (Survanta intratracheal suspension, Ross Prod ucts Division of Abbott Laboratoties), a modified bovine lung extract, in prevention and treatment of neonatal respiratory distress syndrome in premature infants. Data on clinical status were collected for surv iving infants at hospital discharge and at 6, 12, and 24 months of adj usted age. Significantly fewer beractant-treated infants required supp lemental 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 low er incidence of cerebral palsy (p = 0.020). At 12 months of adjusted a ge, 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 beract ant were found in serum samples at 6 and 12 months of age. these resul ts suggest that the increased survival rate associated with beractant treatment is followed through 2 years of adjusted age by outcomes equi valent to those of untreated control infants.