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

This study has suspended participant recruitment.
(PI has left Institution)
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01277874
First received: January 13, 2011
Last updated: December 23, 2015
Last verified: December 2015
  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 CPAP
Device: Oscillatory NCPAP

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:


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: December 2014
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bird Industries

  Eligibility

Ages Eligible for Study:   up to 28 Days   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
United States, California
Valley Children's Healthcare
Madera, California, United States, 93636
United States, Utah
Primary Children's Medical Center
Salt Lake City, Utah, United States, 84113
University of Utah Health Sciences Center
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Donald Null, MD University of Utah
  More Information

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: December 23, 2015
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 September 30, 2016