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

Primary Purpose

Respiratory Distress Syndrome, Prematurity

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Nasal CPAP
Oscillatory NCPAP
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Distress Syndrome

Eligibility Criteria

undefined - 28 Days (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Valley Children's Healthcare
  • Primary Children's Medical Center
  • University of Utah Health Sciences Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Nasal CPAP

Oscillatory NCPAP

Arm Description

Standard Nasal CPAP

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.

Outcomes

Primary Outcome Measures

Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.
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.
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.
Determine the total amount of oxygen exposure in each study group.

Full Information

First Posted
January 13, 2011
Last Updated
March 9, 2017
Sponsor
University of Utah
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1. Study Identification

Unique Protocol Identification Number
NCT01277874
Brief Title
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Official Title
Oscillatory Versus Non-Oscillatory Nasal Continuous Airway Pressure Neonatal Respiratory Support
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Withdrawn
Why Stopped
PI has left Institution
Study Start Date
December 2014 (undefined)
Primary Completion Date
April 2017 (Anticipated)
Study Completion Date
April 2017 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Utah

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Prematurity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal CPAP
Arm Type
Active Comparator
Arm Description
Standard Nasal CPAP
Arm Title
Oscillatory NCPAP
Arm Type
Active Comparator
Arm Description
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 Type
Device
Intervention Name(s)
Nasal CPAP
Intervention Description
NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.
Intervention Type
Device
Intervention Name(s)
Oscillatory NCPAP
Other Intervention Name(s)
Bird Industries
Intervention Description
Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.
Primary Outcome Measure Information:
Title
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP
Description
Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Time Frame
2 months
Title
Need for mechanical ventilation following the initiation of NCPAP.
Description
The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.
Time Frame
2 months
Secondary Outcome Measure Information:
Title
Total duration of non-invasive and invasive respiratory support in each study group.
Description
Determine the total duration of non-invasive and invasive respiratory support in each study group.
Time Frame
2 months
Title
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.
Description
Determine the total amount of oxygen exposure in each study group.
Time Frame
2 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
28 Days
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Donald Null, MD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Valley Children's Healthcare
City
Madera
State/Province
California
ZIP/Postal Code
93636
Country
United States
Facility Name
Primary Children's Medical Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
University of Utah Health Sciences Center
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

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

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