The effects of a single dose of
surfactant TA were assessed in premature neonates (
birth weight 750 to 1749 g) with
respiratory distress syndrome (RDS) in a multicenter, double-blind, randomized clinical trial. Only neonates with
surfactant deficiency and without ultrasonographic evidence of
intracranial hemorrhage greater than or equal to grade II were enrolled. Fifty-four patients received
surfactant (100 mg of
phospholipid per kilogram of
body weight) and 46 patients received an air placebo within 8 hours of life. Treatment with this
surfactant resulted in a significant reduction in the severity of RDS with a concomitant increase in the proportion of neonates with mild disease. The frequency of
pulmonary interstitial emphysema and of
pneumothorax was significantly lower in treated neonates compared with control neonates (2% vs 26%, P = .0008, and 7% vs 39%, P = .0004, respectively). The frequency of
intracranial hemorrhage was significantly lower in the
surfactant group compared with the control group (20% vs 54%, P = .0008) and was also reduced for the smallest neonates in the
surfactant group (13% vs 73%, P = .00008). When categorized according to severity of
intracranial hemorrhage and severity of
bronchopulmonary dysplasia, the
surfactant group was at a significant advantage (adjusted Cochran-Mantel-Haenszel X2 = 10.72, P less than .001 and X2 = 4.43, P = .036, respectively). The proportion of neonates surviving without
intracranial hemorrhage and/or
bronchopulmonary dysplasia was 63% in the
surfactant group vs 26% in the control group (P = .0004); as for the smallest neonates, it was 58% in the
surfactant group vs 4% in the control group (P = .0002). There were no differences between the groups with respect to the frequency of
patent ductus arteriosus (46% vs 37%), pulmonary
hemorrhage (6% vs 7%),
necrotizing enterocolitis (0% vs 2%),
sepsis (4% vs 2%),
retinopathy of prematurity (13% vs 22%), or death (15% vs 22%). It is concluded that treatment with the single-dose
surfactant regimen used in this study reduces the severity of respiratory distress during the 48 hours
after treatment and decreases the major pulmonary morbidity and
intracranial hemorrhage in premature neonates with RDS. Further studies are needed to determine whether (1) treatment at birth or as soon as after RDS is diagnosed and (2) the use of multiple dose of this
surfactant would result in any additional benefits.