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

NCT01277874 | Withdrawn

• 1 other identifier: 36738
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

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.

Conditions

Respiratory Distress Syndrome; Prematurity

Outcome Measures

Primary Outcomes (2)

• Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP

  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.

  The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.

  2 months

Secondary Outcomes (2)

• 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.

  2 months

Study Arms (2)

Nasal CPAP

ACTIVE COMPARATOR

Standard Nasal CPAP

Device: Nasal CPAP

Oscillatory NCPAP

ACTIVE COMPARATOR

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

Interventions

Nasal CPAP DEVICE

NCPAP is delivered via nasal prongs placed into infant's nares. It may be delivered via ventilator or by bubble.

Nasal CPAP

Oscillatory NCPAP DEVICE

Bird Industries pneumatic diaphragm is attached to NCPAP patient circuit to provide oscillations.

Also known as: Bird Industries

Oscillatory NCPAP

Eligibility Criteria

• Age: Up to 28 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Newborn (0-28 days of age) admitted to Neonatal Intensive Care Unit (NICU)
• Ordered respiratory treatment of NCPAP

You may not qualify if:

• Major congenital defect
• Known or suspected chromosomal disorder

Sponsors & Collaborators

• University of Utah: lead

Study Sites (3)

Valley Children's Healthcare

Madera, California, 93636, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113, United States

Location

University of Utah Health Sciences Center

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Respiratory Distress Syndrome; Premature Birth

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Donald Null, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 13, 2011
• First Posted: January 17, 2011
• Study Start: December 1, 2014
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2017
• Last Updated: March 13, 2017

Record last verified: 2017-03

Locations

US (3)