ONE-YEAR FOLLOW-UP OF 66 PREMATURE-INFANTS WEIGHING 500 TO 699 GRAMS TREATED WITH A SINGLE-DOSE OF SYNTHETIC SURFACTANT OR AIR PLACEBO AT BIRTH - RESULTS OF A DOUBLE-BLIND TRIAL

In a multicenter, double-blind, placebo-controlled trial that enrolled 215 premature infants with birth weights of 500 to 699 gm, 106 infant s were treated prophylactically with a single 5 ml/kg dose of syntheti c surfactant and 109 infants were given an equivalent dose of air plac ebo shortly after birth. In each group, 40 children survived infancy: 36 children in the air placebo group and 30 children in the synthetic surfactant group were available for follow-up. Weight, height, and hea d circumference measurements were similar for both groups at 1-year ad justed age. Infants who received synthetic surfactant at birth had sta tistically similar Bayley Scales of Infant Development scores (mental developmental index, 92 vs 83; psychomotor developmental index, 87 vs 82) compared with controls. Mild to moderate impairments in the synthe tic surfactant group were 7% versus 29% in the control group; these di fferences were not statistically significant. The incidence of retinop athy of prematurity, the number of hospital readmissions, the need for surgery after day 28, evidence of chronic lung disease, the need for respiratory support at 1-year adjusted age, and the incidence of aller gies were also not different between the two groups, However, the prop ortion of infants surviving without impairment was modestly higher in the synthetic surfactant group (8%, air placebo group; 23%, synthetic surfactant group). The findings from this small study indicate that in fants weighing 500 to 699 gm who receive a single prophylactic dose of synthetic surfactant at birth have neurodevelopmental outcomes at lea st equivalent to those of infants given air placebo at 1-year follow-u p.