Early randomized intervention with high-frequency jet ventilation in respiratory distress syndrome.
To determine whether early use of high-frequency jet ventilation reduces neonatal mortality or pulmonary morbidity rates, we randomly selected 42 infants with clinical and radiographic evidence of severe respiratory distress syndrome to receive either high-frequency jet ventilation or conventional ventilation. Separate sequential analyses (two-sided, alpha = 0.05, power = 0.95 to detect 85:15 advantage) were performed for mortality rates, air leaks, bronchopulmonary dysplasia, intraventricular hemorrhage, and assignment crossover, and a combined analysis was performed, with death overriding other outcome variables. Enrollment was completed when the combined analysis reached the sequential design boundary indicating no treatment difference. Mortality rates (19% among infants receiving high-frequency jet ventilation vs 24% among infants receiving conventional ventilation), the incidence of air leaks (48% vs 52%), bronchopulmonary dysplasia (39% vs 41%), and intraventricular hemorrhage (33% vs 43%), and assignment crossovers (14% vs 24%) did not differs significantly between the treatment groups. We conclude that early use of high-frequency jet ventilation does not prevent or substantially reduce mortality or morbidity rates associated with assisted ventilation.
Carlo
W A
WA
Department of Pediatrics, Rainbow Babies and Children's Hospital, Case Western Reserve University, Cleveland, Ohio 44106.
Siner
B
B
Chatburn
R L
RL
Robertson
S
S
Martin
R J
RJ
D000367:Age Factors; D002245:Carbon Dioxide / Q000097:blood; D005260:Female; D006611:High-Frequency Jet Ventilation; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D010100:Oxygen / Q000097:blood; D012121:Respiration, Artificial; D012127:Respiratory Distress Syndrome, Newborn / Q000401:mortality / Q000628:therapy*; D013997:Time Factors
D002245:Carbon Dioxide; D010100:Oxygen