Hypothesis: HFOV as first line therapy for respiratory failure in preterm infants will lead to less treatment failures (TF) than an IPPV with a high rate (60-80/min) and low peak pressures. Treatment failure criteria were extraalveolar air (EAL), bronchopulmonary dysplasia (BPD, defined as need for supplemental oxygen at 36 weeks postmenstrual age), death or exceed of an oxygenation index (EOI) of 35-45, depending on the gestational age (GA).Methods: Infants with a GA between 24+0/7 and 29+6/7 weeks (W), who needed mechanical ventilation within 6 hours after birth, were randomly assigned to receive either IPPV or HFOV (with optimization of the lung volume), for 10 days or until extubation or meeting treatment failure criteria. The expected sample size for finding at least a 12% difference in the frequency of treatment failures was between 270 and 373 patients, according to a group sequential plan (α=0.05, β=0.2, onesided test). Secondary outcome criteria were the frequency of grade 3-4 intracranial hemorrhages (IVH), the administration of exogenous surfactant (AES) and the age at the final extubation (AFE). Results: The trial was terminated after recruitment of 284 infants because scheduled interim analyses did not show a reduction of treatment failures in HFOV. Speculation: HFOV may not be less traumatic than a high rate IPPV in preterm infants. Table

Table 1 No caption available.
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