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

Not Applicable

Completed

• Conditions: Apnea of Prematurity; Respiratory Distress Syndrome

• Registration Number: NCT03292562
• Lead Sponsor: The University of Texas Health Science Center, Houston

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-19
• Study First Submitted: 2017-09-21
• Study First Submitted QC: 2017-09-21
• Study First Posted: 2017-09-25
• Primary Completion: 2019-03-01
• Study Completion: 2019-03-31
• Status Verified: 2020-02
• Results First Submitted: 2020-02-29
• Results First Submitted QC: 2020-02-29
• Last Update Submitted: 2020-02-29
• Results First Posted: 2020-03-17
• Last Update Posted: 2020-03-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

• All infants < 30 weeks by dates, on NCPAP therapy, on caffeine 10mg/kg daily
• Meet CPAP stability criteria for ≥ 12hours (CPAP 6 cm water (H2O), FiO2 </=0.25 and stable (to maintain sats 85-95%), Respiratory rate consistently less than 60, Mild to no subcostal/intercostal retractions, No Apnea or bradycardia event that requires bag mask ventilation, Less than 3 apnea/brady/desat episodes in any 1 hour period for previous 6 hours, Tolerated time off CPAP during routine CPAP care (~15 min)

Exclusion Criteria

• Major congenital anomalies including congenital heart disease
• Anomalies that prevent discontinuation of NCPAP
• Undergoing current evaluation for and/or treatment of sepsis

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Number of Days on NCPAP or Mechanical Ventilation	from randomization until 28 days post-randomization	Subjects might go on and off NCPAP or mechanical ventilation throughout the 28 days after randomization, and the total number of days will be reported.

Secondary Outcome Measures

Name	Time	Method
Duration of Endotracheal Ventilation	from randomization until 28 days post-randomization	Subjects might go on and off endotracheal ventilation throughout the 28 days after randomization, and the total number of days will be reported.
Length of Hospital Stay	from admission to hospital until discharge (about 92 days)
Number of Participants Who Developed Necrotizing Enterocolitis	from randomization until discharge (about 92 days)
Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth	from randomization until discharge (about 92 days)
Number of Participants Who Developed Bronchopulmonary Dysplasia	from randomization until discharge (about 92 days)
Number of Participants Who Developed Air Leak Disorders	from randomization until discharge (about 92 days)	Air leak disorders include pneumothorax, pneumomediastinum, and pulmonary interstitial emphysema.
Number of Participants Who Failed to Wean Off NCPAP	from randomization until discharge (about 92 days)

Trial Locations

Locations (1)

The University of Texas Health Science Center at Houston; 🇺🇸 Houston, Texas, United States