N/A
Completed N=66
A Comparison of Methods of Discontinuing Nasal CPAP in Premature Infants <30 Weeks Gestation
Apnea of Prematurity · Acute Respiratory Distress Syndrome
Source: ClinicalTrials.gov NCT03292562 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcomePrimary: Number of Days on NCPAP or Mechanical Ventilation — 17.3; 12.3 days
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.
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 | — |
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
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. Informational only — not medical advice.