A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
- Conditions
- Apnea of PrematurityRespiratory Distress Syndrome
- Interventions
- Device: Discontinue NCPAP after weaning pressuresDevice: Discontinue NCPAP without weaning pressures
- Registration Number
- NCT03292562
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 66
- 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)
- 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
- Arm && Interventions
Group Intervention Description Discontinue NCPAP after weaning pressures 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). Discontinue NCPAP without weaning pressures 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).
- 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 Number of Participants Who Failed to Wean Off NCPAP from randomization until discharge (about 92 days) 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.
Trial Locations
- Locations (1)
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States