Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Utah System of Higher Education (USHE)

Status: Withdrawn

Conditions: Prematurity; Respiratory Distress Syndrome

Treatments: Device: Oscillatory NCPAP; Device: Nasal CPAP

Study type: Interventional

Funder types: Other

Identifiers

NCT01277874

36738

Details and patient eligibility

About

This study will seek to enroll neonates requiring Nasal Continuous Airway Pressure (NCPAP) respiratory support and randomize them to either oscillatory (Osc-NCPAP, study group) or non-oscillatory (NCPAP, control group) mode. The goal of the research is to determine if Osc-NCPAP provides improved ventilation support compared to routine NCPAP, i.e. NCPAP without oscillations. This will be measured by need for change to ventilator support, improvement in pCO2 values, and reduction in respiratory rate and frequency of apnea during the period of NCPAP treatment. Other respiratory outcomes will also be compared, including time on NCPAP, time on High-Flow Nasal Cannula support following NCPAP, and time-averaged PiO2 from start of study to end of respiratory treatment.

Sex: All

Ages: Under 28 days old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
• Ordered respiratory treatment of NCPAP

Exclusion criteria

• Major congenital defect
• Known or suspected chromosomal disorder

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Nasal CPAP

Active Comparator group

Description:

Standard Nasal CPAP

Treatment:

Device: Nasal CPAP

Oscillatory NCPAP

Active Comparator group

Description:

NCPAP will be given to infant via prongs in the infant's nose. A Bird Industries pneumatic oscillating diaphragm to drive a Bird Industries phasatron which is attached by T-connector to the NCPAP patient circuit.

Treatment:

Device: Oscillatory NCPAP