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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2014 by University of Utah
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT01277874
First received: January 13, 2011
Last updated: June 16, 2014
Last verified: June 2014
  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:


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: September 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (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
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

Contacts
Contact: Carolyn Smith, RN 801-662-4183 carolyn.smith@hsc.utah.edu
Contact: Donald Null, MD 801.587.7052 Donald.Null@imail.org

Locations
United States, Utah
Primary Children's Medical Center Not yet 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 Not yet 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: June 16, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Respiratory Distress Syndrome, Newborn
Infant, Newborn, Diseases
Infant, Premature, Diseases
Lung Diseases
Respiration Disorders
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on October 21, 2014