THE PROVE MULTICENTER EARLY HIGH-FREQUENCY OSCILLATORY VENTILATION TRIAL - IMPROVED PULMONARY AND CLINICAL OUTCOME IN RESPIRATORY-DISTRESS SYNDROME

Objective. To compare the hospital course and clinical outcome of pret erm infants with respiratory distress syndrome treated with surfactant and managed with high-frequency oscillatory ventilation (HFOV) or con ventional mechanical ventilation (CV) as their primary mode of ventila tor support. Design. A prospective randomized clinical trial. Setting. Three community-based level III neonatal intensive care units. Subjec ts. A total of 125 neonates who were 35 weeks or less estimated gestat ion requiring intubation and assisted ventilation for respiratory dist ress syndrome with arterial to alveolar oxygen ratio less than .50. In terventions. Patients were randomized to continue CV (61 patients) or be changed to HFOV (64 patients) after exogenous surfactant administra tion (100 mg/kg). HFOV was used in a strategy to promote lung recruitm ent and maintain lung volume. protocol respiratory care guidelines wer e followed; otherwise routine care was provided by each neonatal inten sive care unit. Measurements and Main Results. No differences were not ed in demographic features between the two study groups. The study pop ulation birth weight was 1.51 +/- .47 kg (mean +/- SD), gestational ag e was 30.9 +/- 2.5 weeks, and study entry age was 2 to 3 hours. Patien ts randomized to HFOV demonstrated the following significant findings compared with CV-treated patients: vasopressor support was less intens ive; surfactant redosing was not as frequent; oxygenation improved mor e rapidly and remained higher during the first 7 days; fewer infants r equired prolonged supplemental oxygen or ventilator support; treatment failure was reduced; more patients survived without chronic lung dise ase at 30 days; need far continuous supplemental oxygen at discharge w as less; frequency of necrotizing enterocolitis illness was lower; the re were fewer abnormal hearing tests; and hospital casts were decrease d. No differences were seen between the two study groups in the freque ncy or severity of patent ductus arteriosus, air leak retinopathy of p rematurity, or intraventricular hemorrhage. Length of hospital stay an d survival to discharge were similar for HFOV- and CV-treated infants. Conclusions. When used early with a lung recruitment strategy, HFOV a fter surfactant replacement resuited in clinical outcomes consistent w ith a reduction in both acute and chronic lung injury. Benefit was evi dent for preterm infants both less than or equal to 1 kg and more than 1 kg. In addition, early HFOV treatment may have had a more global ef fect on patient health throughout the hospitalization, resulting in re duced morbidity and decreased health tare cost.