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

NCT01277874 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2017-03-13

No results posted yet for this study

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

Interventions

DEVICE

Nasal CPAP

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

DEVICE

Oscillatory NCPAP

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

Sponsors & Collaborators

Principal Investigators

  • Donald Null, MD · University of Utah

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
28 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-04-30
Completion
2017-04-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01277874 on ClinicalTrials.gov