Nasal flow-synchronized intermittent positive pressure ventilation to facilitate weaning in very low-birthweight infants: Unmasked randomized controlled trial

Background: Nasal flow-synchronized intermittent positive pressure ventilation (NFSIPPV) is a new non-invasive ventilatory mode that delivers synchronized mechanical breaths through the nasal prongs. An unmasked, prospective randomized controlled trial was conducted to compare the efficacy of NFSIPPV and conventional nasal continuous positive airway pressure (NCPAP) in increasing the likelihood for successful extubation in very low-birthweight infants. Methods: Consecutive infants who weighed < 1251 g at birth, required endotracheal intubation within 48 h of birth and met specific predetermined criteria for extubation by day 14 of life were recruited. Each infant was randomized to receive either NFSIPPV or NCPAP soon after extubation. Extubation was deemed successful if re-intubation was not needed for at least 72 h. Criteria for re-intubation were persistent severe respiratory acidosis (arterial pH < 7.20 with pCO2 > 70 mmHg), severe recurrent apneic episodes not responding to increased ventilatory settings and then requiring bag ventilation, and hypoxemia (SaO2 < 90% or pO2 < 60 mmHg with FiO2 >= 0.70). Results: There were no significant differences in clinical characteristics between the two groups at randomization. Ninety-four percent (30/32) infants were successfully extubated to NFSIPPV but only 61% (19/31) to conventional NCPAP (P > 0.005). Infants assigned to NCPAP failed extubation mainly because of apnea and hypercapnia, and those assigned to NFSIPPV because of hypoxia. Neither procedure induced major adverse effects. Conclusions: NFSIPPV in the post-extubation period is safe and more effective than NCPAP in preventing re-ventilation.