NCT02003846 - Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants | Crick

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

18

Conditions

Respiratory Distress Syndrome

Eligibility

Sex: ALLMin age: 2 DaysMax age: 3 Months

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

Locations (1)

Maimonides Medical Center

Brooklyn, New York, United States

Outcomes

Primary Outcomes

Physiologic parameters

heart rate, respiratory rate, oxygen saturation

Time frame: 2 hours

Secondary Outcomes

Physiologic parameters

cerebral oxygen tissue extraction

Time frame: 2 hours