Background: Controversy still exits with respect to timing of surfactant administration in preterm infants at risk for or with manifest RDS. We therefore aimed to investigate in a multicenter trial whether early (<1h following birth) or late (>2h following birth) surfactant administration would be superior. Subjects and methods: All infants with a gestational age from 27-32 weeks were enrolled stratified by center after prenatal parental informed consent. Early treatment with surfactant (100 mg/kg b.w. Alveofact® i.t.) was given to infants requiring intubation following birth, late treatment was given with an identical dosage to infants on mechanical ventilation with a FiO2 >0.4 between hours 2-6 following birth. The primary end point was the time on mechanical ventilation, secondary endpoints included mortality, BPD (28 days FiO2 >0.21 or mechanical ventilation), IVH >III/PVL. Sample size calculation revealed a total of 200 infants would have to be included to (α=0.05; β=0.80).Results: 236 infants were enrolled, 146 needed intubation and mechanical ventilation. Table 1 gives an overview on most relevant study data (intent-to-treat analysis).

Table 1
Full size table

In early treated infants on mechanical ventilation (n=68), mean duration of mechanical ventilation was 7.39 days (±9.7) compared to 7.01±7.39 days in the late treatment group (n=78).Conclusion: Early natural surfactant given to infants of 27-32 weeks GA with need for intubation following birth offers no advantage compared with late treatment in terms of time on mechanical ventilation and other relevant neonatal outcome variables.