Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants
Completed
Conditions studied: Respiratory Distress Syndrome
In brief
There are various methods to generate the pressure needed for Nasal CPAP. Some neonatal intensive care units (NICU) use an underwater bubbling system and others use a ventilator to generate the pressure. There is no right or wrong way to generate the pressure and both methods are approved and accepted. The aim of this study is to compare the two systems of Nasal CPAP by placing the baby on each for a defined time period and reviewing the infant's vital signs. The investigators expect that the pressure generated by bubble CPAP will be better and lead to improved vital signs.
Key facts
- Study ID
- NCT02003846
- Run by
- Maimonides Medical Center
- People needed
- 18
- Starts
- 2013-11-01
- Expected to finish
- 2014-10-01
- Last updated by the study team
- 2015-06-30
Who can join
Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Neonates between 26-32 weeks gestational age who have been on Nasal CPAP for at least 48hrs on fraction of inspired oxygen (FiO2) of < or = 0.3. Parental consent will be obtained prior to enrollment.
You may not qualify if…
- Infants with severe congenital anomalies, such as airway or chest wall deformities, pulmonary hypoplasia, congenital heart disease, neurologic abnormalities including severe intraventricular hemorrhage (IVH) and need for surgery eg. for necrotizing enterocolitis will be excluded from the study. Any infants with genetic/chromosomal abnormalities will be excluded.
Where it is running
- Maimonides Medical Center — Brooklyn, New York, United States
Full record on ClinicalTrials.gov
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