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

This study is not yet open for participant recruitment.

Verified June 2013 by University of Utah

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT01277874

First received: January 13, 2011

Last updated: June 14, 2013

Last verified: June 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

January 13, 2011

Last Updated Date

June 14, 2013

Start Date ^ICMJE

September 2013

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01277874 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Total duration of non-invasive and invasive respiratory support in each study group. [ Time Frame: 2 months ] [ Designated as safety issue: No ]
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. [ Time Frame: 2 months ] [ Designated as safety issue: Yes ]
Determine the total amount of oxygen exposure in each study group.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Respiratory Distress Syndrome
Prematurity

Intervention ^ICMJE

Device: Nasal Continuous Positive Airway Pressure (NCPAP)
NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
Device: Oscillating Nasal Continuous Positive Airway Pressure
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.

Other Name: Bird Industries

Study Arm (s)

Active Comparator: Non-Oscillating NCPAP
Standard Nasal Continuous Positive Airway Pressure

Intervention: Device: Nasal Continuous Positive Airway Pressure (NCPAP)
Active Comparator: 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.

Intervention: Device: Oscillating Nasal Continuous Positive Airway Pressure

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

246

Estimated Completion Date

January 2015

Estimated Primary Completion Date

January 2015 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

up to 28 Days

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Karen Osborne, RN	801.587.7052	Karen.Osborne@hsc.utah.edu
Contact: Donald Null, MD	801.587.7052	Donald.Null@imail.org

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01277874

Other Study ID Numbers ^ICMJE

36738

Has Data Monitoring Committee

Responsible Party

Donald Null M.D., University of Utah / Primary Childrens Medical Center

Study Sponsor ^ICMJE

University of Utah

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Donald Null, MD

University of Utah

Information Provided By

University of Utah

Verification Date

June 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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