PROSPECTIVE, RANDOMIZED COMPARISON OF HIGH-FREQUENCY OSCILLATION AND CONVENTIONAL VENTILATION IN CANDIDATES FOR EXTRACORPOREAL MEMBRANE-OXYGENATION

Objective: To compare the safety and efficacy of high-frequency oscill ation (HFO) with conventional ventilation in the treatment of neonates with respiratory failure. Design: We conducted a multicenter, prospec tive, randomized trial. Patients were stratified according to pulmonar y diagnosis and then were randomly selected for conventional ventilati on or HFO. A balanced crossover design offered patients who met criter ia of treatment failure a trial of the alternative mode of ventilation . Setting: Four tertiary, level 3 neonatal intensive care units accept ing regional referrals for extracorporeal membrane oxygenation. Patien ts: Neonates were eligible for enrollment if their gestational age was >34 weeks, their birth weight was greater than or equal to 2 kg, they were <14 days of age, they required fractional inspired oxygen >0.50 and a mean airway pressure >0.98 kPa (10 cm H2O) to support adequate o xygenation, and they required a peak inspiratory pressure >2.9 kPa (30 cm H2O) and a rate >40 breaths per minute to support adequate ventila tion. Exclusion criteria were lethal congenital anomalies, profound sh ock, need for cardiopulmonary resuscitation, and failure to obtain con sent. Main results: Of 79 patients studied, 40 were assigned to conven tional ventilation and 39 to HFO. Neonates randomly assigned to HFO re quired higher peak pressure (3.8 +/- 0.5 vs 3.3 +/- 0.8 kPa, 39 +/- 5 vs 34 +/- 8 cm H2O; p = 0.004) and more often met extracorporeal membr ane oxygenation criteria (67% vs 40%; p = 0.03) at study entry than di d those given conventional ventilation. Twenty-four patients (60%) ass igned to conventional ventilation met treatment failure criteria compa red with 17 (44%) of those assigned to HFO (not significant). Of the 2 4 patients in whom conventional ventilation failed, 15 (63%) responded to HFO; 4 (23%) of the 17 in whom HFO failed responded to conventiona l ventilation (p = 0.03). There were no differences between the two gr oups with respect to outcome, need for extracorporeal membrane oxygena tion, or complications. Conclusions: We conclude that HFO is a safe an d effective rescue technique in the treatment of neonates with respira tory failure in whom conventional ventilation fails.