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NCT Number: NCT01277874

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

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.

Why the study stopped: PI has left Institution
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Key information

Conditions

Respiratory Distress Syndrome Female Urogenital Diseases and Pregnancy Complications Lung Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Prematurity Respiration Disorders Respiratory Tract Diseases Urogenital Diseases

Age range

Up to 28 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Valley Children's Healthcare, Madera, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

nasal CPAP

Device

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

Oscillatory NCPAP

Device

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

Other names: Bird Industries

Primary outcomes

  1. 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. 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.

Secondary outcomes

  1. 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. 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Registry information

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jan 17, 2011
Registry last updated
Aug 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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