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

NCT ID: NCT01277874

Last Updated: 2017-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2017-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Respiratory Distress Syndrome Prematurity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Nasal CPAP

Standard Nasal CPAP

Group Type ACTIVE_COMPARATOR

Nasal CPAP

Intervention Type DEVICE

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

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.

Group Type ACTIVE_COMPARATOR

Oscillatory NCPAP

Intervention Type DEVICE

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

Interventions

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Nasal CPAP

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

Intervention Type DEVICE

Oscillatory NCPAP

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

Intervention Type DEVICE

Other Intervention Names

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Bird Industries

Eligibility Criteria

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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
Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Utah

OTHER

Sponsor Role lead

Responsible Party

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University of Utah / Primary Childrens Medical Center

Principal Investigators

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Donald Null, MD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

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Valley Children's Healthcare

Madera, California, United States

Site Status

Primary Children's Medical Center

Salt Lake City, Utah, United States

Site Status

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Site Status

Countries

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United States

Other Identifiers

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36738

Identifier Type: -

Identifier Source: org_study_id

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