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

Status

Withdrawn

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01277874

Enrollment

Registered

2011-01-17

Start date

2014-12-31

Completion date

2017-04-30

Last updated

2017-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Distress Syndrome, Prematurity

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.

Interventions

DEVICENasal CPAP

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

DEVICEOscillatory NCPAP

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

No minimum to 28 Days

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Physiologic respiratory stability of Oscillating versus Non-Oscillating NCPAP	2 months	Determine the physiologic respiratory stability (pCO2, respiratory rate, apnea frequency) during treatment with NCPAP
Need for mechanical ventilation following the initiation of NCPAP.	2 months	The rate of mechanical ventilation following both Oscillating and Non-Oscillating groups.

Secondary

Measure	Time frame	Description
Total duration of non-invasive and invasive respiratory support in each study group.	2 months	Determine the total duration of non-invasive and invasive respiratory support in each study group.
total amount of oxygen exposure in each study group. Total amount of oxygen exposure in each study group.	2 months	Determine the total amount of oxygen exposure in each study group.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026