NCT03292562

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

A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation - a Feasibility Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: The University of Texas Health Science Center, Houston · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2017-09-19
• Primary completion: 2019-03-01
• Completion: 2019-03-31
• First posted: 2017-09-25
• Last updated: 2020-03-17
• Results posted: 2020-03-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study