Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

Maimonides Medical Center

Status: Completed

Conditions: Respiratory Distress Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT02003846

MMC 2013-02-10 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 18 patients

Sex: All

Ages: 2 days to 3 months old

Volunteers: No Healthy Volunteers

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.

Trial design

18 participants in 1 patient group

Premature infant

Description:

Each premature infant will be on bubble nasal CPAP for 2 hours and on ventilator nasal CPAP for 2 hours