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NCT01277874 Clinical Trial

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

Respiratory Distress Syndrome Clinical Trial

Official title:
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT01277874
Other study ID # 36738
Secondary ID
Status Withdrawn
Phase N/A
First received January 13, 2011
Last updated March 9, 2017
Start date December 2014
Est. completion date April 2017

Study information
Verified date March 2017
Source University of Utah
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date April 2017
Est. primary completion date April 2017
Accepts healthy volunteers No
Gender All
Age group N/A to 28 Days
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Nasal CPAP
NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
• Oscillatory NCPAP
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.

Locations
Country Name City State
United States Valley Children's Healthcare Madera California
United States Primary Children's Medical Center Salt Lake City Utah
United States University of Utah Health Sciences Center Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
University of Utah

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP 2 months
Primary Need for mechanical ventilation following the initiation of NCPAP. The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups. 2 months
Secondary Total duration of non-invasive and invasive respiratory support in each study group. Determine the total duration of non-invasive and invasive respiratory support in each study group. 2 months
Secondary total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group. Determine the total amount of oxygen exposure in each study group. 2 months
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