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

This study is currently recruiting participants.

Verified January 2013 by University of Utah

Sponsor:

Information provided by:

University of Utah

ClinicalTrials.gov Identifier:

NCT01277874

First received: January 13, 2011

Last updated: January 4, 2013

Last verified: January 2013

History of Changes

Purpose

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.

Condition	Intervention
Respiratory Distress Syndrome Prematurity	Device: Nasal Continuous Positive Airway Pressure (NCPAP) Device: Oscillating Nasal Continuous Positive Airway Pressure

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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.

Estimated Enrollment:	246
Study Start Date:	January 2012
Estimated Study Completion Date:	January 2014
Estimated Primary Completion Date:	January 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Non-Oscillating NCPAP Standard Nasal Continuous Positive Airway Pressure	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.
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.	Device: Oscillating Nasal Continuous Positive Airway Pressure Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations. Other Name: Bird Industries

Eligibility

Ages Eligible for Study:	up to 28 Days
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01277874

Contacts

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

Locations

United States, Utah
Primary Children's Medical Center	Recruiting
Salt Lake City, Utah, United States, 84113
Contact: Donald N-u-l-l, MD 801-662-4100 donald.null@hsc.utah.edu
Principal Investigator: Donald N-u-l-l, MD
University of Utah Health Sciences Center	Recruiting
Salt Lake City, Utah, United States, 84132
Contact: Donald Null, MD 801-662-4100 donald.null@hsc.utah.edu
Contact: Dale Gerstmann, MD 801-588-3865
Principal Investigator: Donald N-u-l-l, MD

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Donald Null, MD

University of Utah

More Information

No publications provided

Responsible Party:	Donald Null M.D., University of Utah / Primary Childrens Medical Center
ClinicalTrials.gov Identifier:	NCT01277874 History of Changes
Other Study ID Numbers:	36738
Study First Received:	January 13, 2011
Last Updated:	January 4, 2013
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Lung Diseases
Respiratory Tract Diseases

Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases

ClinicalTrials.gov processed this record on May 23, 2013

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