OUTCOME AT 1-YEAR ADJUSTED AGE OF 957 INFANTS WEIGHING MORE THAN 1250GRAMS WITH RESPIRATORY-DISTRESS SYNDROME RANDOMIZED TO RECEIVE SYNTHETIC SURFACTANT OR AIR PLACEBO
R. Sauve et al., OUTCOME AT 1-YEAR ADJUSTED AGE OF 957 INFANTS WEIGHING MORE THAN 1250GRAMS WITH RESPIRATORY-DISTRESS SYNDROME RANDOMIZED TO RECEIVE SYNTHETIC SURFACTANT OR AIR PLACEBO, The Journal of pediatrics, 126(5), 1995, pp. 75-80
This study determined outcomes at 12-months adjusted age of 957 infant
s weighing more than 1250 gm at birth who were subjects in a randomize
d, double-blind, controlled trial of synthetic surfactant or air place
bo administered in a rescue trial at 23 hospitals in the United States
and 13 hospitals in Canada. Follow-up results were available for 475
of 563 surviving infants who received air placebo (84%) and 482 of 571
infants who received synthetic surfactant (84%), Developmental outcom
e was equivalent in the two groups, Morbidity was less in the syntheti
c surfactant group as assessed by the need for medication for chronic
lung disease (52 of 475 (11%) for the air placebo group vs 32 of 482 (
7%) for the synthetic surfactant group) or respiratory support (10 of
475 (2%) for the air placebo group vs 1 of 482 (<1%) for the synthetic
surfactant group) at 1-year adjusted age. Bayley Scales of Infant Dev
elopment (mental development index: 102 for both the air placebo and s
ynthetic surfactant groups; psychomotor development index: 95 for the
air placebo group vs 94 for the synthetic surfactant group) and impair
ment rates (94 of 475 (20%) for the air placebo group vs 86 of 482 (18
%) for the synthetic surfactant group) were similar in the two groups.
Infants weighing more than 1250 gm who have respiratory distress synd
rome have previously been shown to have improved survival rates and lo
wer neonatal morbidity after treatment with synthetic surfactant. Thes
e follow-up data confirm that developmental outcome as determined at 1
2-months adjusted age is at least as good in those receiving synthetic
surfactant.