N/A N=66 Randomized Supportive Care

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

Apnea of Prematurity · Respiratory Distress Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT03292562 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Mar 2020

Primary outcome: Primary: Number of Days on NCPAP or Mechanical Ventilation — 17.3; 12.3 days

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Discontinue NCPAP after weaning pressures (Device); Discontinue NCPAP without weaning pressures (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: The University of Texas Health Science Center, Houston
Primary completion: Mar 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Days on NCPAP or Mechanical Ventilation	17.3; 12.3	—
SECONDARY Duration of Endotracheal Ventilation	—	—
SECONDARY Number of Participants Who Failed to Wean Off NCPAP	13; 16	—
SECONDARY Number of Participants Who Developed Bronchopulmonary Dysplasia	18; 14	—
SECONDARY Number of Participants Who Developed Necrotizing Enterocolitis	0; 0	—
SECONDARY Number of Days of Life at Which Infant Starting Taking All Feeds by Mouth	78; 73	—
SECONDARY Length of Hospital Stay	91.2; 93.3	—
SECONDARY Number of Participants Who Developed Air Leak Disorders	0; 0	—

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03292562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.