Early Versus Late Surfactant Treatment in Preterm Infants of 27 to 32 Weeks' Gestational Age: A Multicenter Controlled Clinical Trial

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Abstract
Objective.: To investigate whether early (0.4 at 2 to 6 hours after birth. Primary endpoint: the time on mechanical ventilation. Main secondary endpoints: mortality, bronchopulmonary dysplasia, intraventricular hemorrhage ≥grade III, and periventricular leukomalacia. Sample size calculation: at least 280 infants to prove superiority of either approach (α = 0.05; β = 0.90).Results.: Enrollment of 317 infants, 154 randomized to early surfactant treatment, 163 to late surfactant treatment. Study infants (all following data intent-to-treat groups: early versus late surfactant) were similar with respect to: gestational age, 29.5 ± 1.6 weeks versus 29.7 ± 1.6 weeks; birth weight, 1227 ± 367 g versus 1269 ± 334 g; and the rate of prenatal corticosteroids, 79.9% versus 72.8%. Duration of mechanical ventilation: 3 days (0–8) versus 2 days (0–6) (median, interquartile); further outcome variables: death or bronchopulmonary dysplasia (day 28) 25.9% versus 23.9%, mortality 3.2% versus 1.8%, intraventricular hemorrhage ≥grade III 6.5% versus 3.7%, and periventricular leukomalacia 5.2% versus 5.5% not differing statistically.Conclusion.: In preterm infants with a high rate of prenatal glucocorticoids, early surfactant administration was not found to be superior to late treatment in terms of relevant outcome variables.

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