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

March 9, 2017 updated by: University of Utah
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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Madera, California, United States, 93636
        • Valley Children's Healthcare
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah Health Sciences Center
      • Salt Lake City, Utah, United States, 84113
        • Primary Children's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 weeks (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Nasal CPAP
Standard Nasal CPAP
Device: Nasal CPAP
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: Oscillatory NCPAP
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
Other Names:
  • Bird Industries

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total duration of non-invasive and invasive respiratory support in each study group.
Time Frame: 2 months
Determine the total duration of non-invasive and invasive respiratory support in each study group.
2 months
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.
Time Frame: 2 months
Determine the total amount of oxygen exposure in each study group.
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2014

Primary Completion (ANTICIPATED)

April 1, 2017

Study Completion (ANTICIPATED)

April 1, 2017

Study Registration Dates

First Submitted

January 13, 2011

First Submitted That Met QC Criteria

January 13, 2011

First Posted (ESTIMATE)

January 17, 2011

Study Record Updates

Last Update Posted (ACTUAL)

March 13, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36738

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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