Aim: To prove the hypothesis that sustained pressure-controlled inflation compared to intermittent mandatory ventilation for lung recruitment via nasopharyngeal tube after delivery is more effective in reducing the rate of endotracheal intubation and mechanical ventilation in very preterm infants.
Methods: The study was designed as a randomized, controlled trial. The setting was the delivery room and neonatal intensive care unit of a university hospital in Germany. Subjects were 61 infants (25.0-28.9 wk of gestation) with signs of respiratory distress immediately after birth. The infants were randomized in the delivery room to two different respiratory interventions: either to sustained pressure-controlled inflation (15 s) or to intermittent mandatory ventilation (rate 60 min(-1)). This respiratory support was given by a nasopharyngeal tube. The inflation pressure or peak inspiratory pressure was increased stepwise (20-25-30 cm H2O) according to the response of heart rate and oxygenation.
Results: The main outcome measure was treatment failure, i.e., endotracheal intubation and mechanical ventilation according to given intubation criteria. Treatment failure occurred in 61% (95% CI, sustained pressure-controlled inflation: 42-78) and 70% (95% CI, intermittent mandatory ventilation: 51-85) (p = 0.59). The rates of mortality (3/61), severe intraventricular haemorrhage (5/61) and chronic lung disease (10/58) were not different between groups.
Conclusion: Sufficient spontaneous breathing within the first 48 h of life without endotracheal intubation and mechanical ventilation was achieved in about 30% with both methods of initial respiratory support.