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

University of Utah

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Respiratory Distress Syndrome Prematurity

Interventions

Nasal CPAPDEVICE

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

Oscillatory NCPAPDEVICE

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

Eligibility

Sex: ALLMax age: 28 Days

Medical Language ↔ Plain English

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

Locations (3)

Valley Children's Healthcare

Madera, California, United States

Primary Children's Medical Center

Salt Lake City, Utah, United States

University of Utah Health Sciences Center

Salt Lake City, Utah, United States

Outcomes

Primary Outcomes

Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP

Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP

Time frame: 2 months

Need for mechanical ventilation following the initiation of NCPAP.

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

Time frame: 2 months

Secondary Outcomes

Total duration of non-invasive and invasive respiratory support in each study group.

Determine the total duration of non-invasive and invasive respiratory support in each study group.

Time frame: 2 months

total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.

Determine the total amount of oxygen exposure in each study group.

Time frame: 2 months

Data from ClinicalTrials.gov

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