MedTrace Logo

A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation

NCT03292562 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2020-03-17

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if among infants \<30 weeks gestational age on nasal continuous positive airway pressure (NCPAP), whether discontinuing CPAP after gradual reduction in continuous positive airway pressure (CPAP) pressure leads to successful weaning off CPAP when compared to discontinuing CPAP without weaning pressure.

Conditions

  • Apnea of Prematurity
  • Respiratory Distress Syndrome

Interventions

DEVICE

Discontinue NCPAP after weaning pressures

After randomization, CPAP pressure will be weaned by 1 every 24hours as long as the subjects continue to meet stability criteria after each wean, until CPAP of 4. If after decrease in CPAP pressure, the subject meets CPAP failure criteria pressure will be increased back to the previous level and after stabilization for 24 hours weaning process will be started again. Once the subject meets stability criteria on CPAP of 4, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

DEVICE

Discontinue NCPAP without weaning pressures

After randomization, once the subject meets stability criteria, NCPAP will be stopped and subject will be placed on nasal cannula (NC) according to unit guidelines (max 1 Liter flow, 30% FiO2).

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Brittany Duyka, MD · The University of Texas Health Science Center, Houston

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-19
Primary Completion
2019-03-01
Completion
2019-03-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

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 NCT03292562 on ClinicalTrials.gov