A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants

This study is designed to test the hypothesis that among infants born at less than 30 weeks,
weighing less than 1500 g at delivery, and receiving initial respiratory support
non-invasively or on invasive respiratory support and meeting extubation criteria in the
first 72 h of life, fewer neonates managed on Seattle--PAP will require endotracheal
intubation and conventional mechanical ventilation (CMV) than will neonates managed from
birth on bubble nasal continuous positive airway pressure (Bn-CPAP) using the Fischer- &
Paykel (FP) device. Neonates on nasal continuous positive airway pressure (CPAP) in the
delivery room or who are stabilized on mechanical ventilation as their initial form of
respiratory support and meet our criteria for extubation within 72 h of birth will be
eligible for randomization and study.

The primary endpoint of this study is the cumulative incidence of respiratory failure
requiring intubation that occurs in patients after randomization and before 36 weeks post
menstrual age (PMA) or discharge, whichever comes first. Presently, the literature supports
that this age group typically exhibits intubation rates of 50% or more, which is consistent
with the data from the Nationwide Children's Hospital/Ohio State University (NCH/OSU)
Neonatal Intensive Care Unit (NICU).