Comparing Bubble and Ventilator Nasal CPAP in Preterm Infants

Completed

• Conditions: Respiratory Distress Syndrome

• Registration Number: NCT02003846
• Lead Sponsor: Maimonides Medical Center

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-19
• Study First Submitted QC: 2013-12-02
• Study First Posted: 2013-12-06
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-27
• Last Update Posted: 2015-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Physiologic parameters	2 hours	heart rate, respiratory rate, oxygen saturation

Secondary Outcome Measures

Name	Time	Method
Physiologic parameters	2 hours	cerebral oxygen tissue extraction

Trial Locations

Locations (1)

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States