A Study to Evaluate the Efficacy of Seattle-PAP for the Respiratory Support of Premature Infants
Status unconfirmed · Not applicable
Conditions studied: Premature Birth
In brief
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).
Key facts
- Study ID
- NCT03085329
- Run by
- Seattle Children's Hospital
- People needed
- 220
- Starts
- 2017-02-10
- Expected to finish
- 2019-02-09
- Last updated by the study team
- 2017-03-22
Who can join
Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Informed consent from parents, less than 30 weeks postmenstrual age at birth, within 72 h of postnatal age spontaneously breathing and able to sustain SaO2 of greater than 90% on less than or equal to FiO2 of 0.40 and 6 cm H2O pressure
You may not qualify if…
- Cardiopulmonary malformations (cardiac valve atresia, lung atresia)
- Congenital malformations (examples: anencephaly, omphalocele, Tetralogy of Fallot) Genetic anomalies (examples: Trisomy 21, Trisomy 18).
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States (enrolling)
Full record on ClinicalTrials.gov
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