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

Not Applicable

Withdrawn

• Conditions: Prematurity; Respiratory Distress Syndrome
• Interventions: Device: Oscillatory NCPAP; Device: Nasal CPAP

• Registration Number: NCT01277874
• Lead Sponsor: University of Utah

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-01-13
• Study First Submitted QC: 2011-01-13
• Study First Posted: 2011-01-17
• Study Start: 2014-12
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-09
• Last Update Posted: 2017-03-13
• Primary Completion: 2017-04
• Study Completion: 2017-04

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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Exclusion Criteria

• Major congenital defect
• Known or suspected chromosomal disorder

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oscillatory NCPAP	Oscillatory NCPAP	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.
Nasal CPAP	Nasal CPAP	Standard Nasal CPAP

Primary Outcome Measures

Name	Time	Method
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP	2 months	Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.	2 months	The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.

Secondary Outcome Measures

Name	Time	Method
Total duration of non-invasive and invasive respiratory support in each study group.	2 months	Determine the total duration of non-invasive and invasive respiratory support in each study group.
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.	2 months	Determine the total amount of oxygen exposure in each study group.

Trial Locations

Locations (3)

Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Valley Children's Healthcare; 🇺🇸 Madera, California, United States

University of Utah Health Sciences Center; 🇺🇸 Salt Lake City, Utah, United States