N/A
N=80
Effective Approaches & Strategies to Ease Off Nasal CPAP In Preterm Infants
Neonatal Respiratory Distress Syndrome · Extremely Low Birth Weight Infant (ELBW) · BronchoPulmonary Dysplasia
Bottom Line
View on ClinicalTrials.gov: NCT02819050 ↗Enrolled (actual)
80
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcome: Primary: Number of Participants With Successful Wean Off CPAP at the First Attempt — 31; 30 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NCPAP (Device)
- Age
- Pediatric, Adult, Older Adult · 0+ yrs
- Sex
- All
- Sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Primary completion
- Jan 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Wean Off CPAP at the First Attempt |
31; 30 | — |
| SECONDARY Number of Participants With Bronchopulmonary Dysplasia |
11; 14 | — |
| SECONDARY Number of Participants With Retinopathy of Prematurity (ROP) |
12; 15 | — |
| SECONDARY Number of Participants With Periventricular Leukomalacia (PVL) |
0; 1 | — |
| SECONDARY Length of Stay (Days) |
82.5; 78 | — |
| SECONDARY Corrected Gestational Age at Time of Discharge/Transfer |
33.4; 33.2 | — |
| SECONDARY Number of Attempts to Wean Off CPAP |
1; 1 | — |
| SECONDARY Number of Days on Protocol |
7; 7 | — |
Summary
Though Nasal Continuous Positive Airway Pressure (NCPAP) is a commonly used form of non-invasive neonatal respiratory support, the optimal method of weaning off NCPAP is not well established. In this prospective, two-center randomized control trial we hypothesize that gradually increasing time off NCPAP (sprinting) increases the success of weaning NCPAP off in infants born between 23 0/7-30 6/7 weeks of gestational age.
Eligibility Criteria
Inclusion Criteria
- Born between 23 0/7 - 30 6/7 weeks GA
- At least 26 0/7 weeks corrected GA.
- On NCPAP for at least 24 hours
- Stable on ≤0.3 FiO2 for at least 24 hours
Initiation of study protocol, i.e., weaning from NCPAP, was started when infant met all of the following criteria for at least 24 hours:
- Requiring NCPAP of 4-6 cm of H2O and FiO2 ≤0.3.
- All babies 86%) and otherwise deemed clinically stable for weaning off non-invasive ventilation by medical team
- If post-surgery, infant must be at least 2 weeks post-operative and off antibiotics with no concern or need for repeat surgery.
- A documented hemoglobin of more than 8 g/dl within 7 days of initiation of the study.
- Meeting "stability criteria" defined below:
- The infant had to be tolerating a flow of no more than 2 liters NC on a FiO2 of 0.30 or less to keep oxygen saturations above 85% (should match what you wrote below in failure criteria)%.
- Have a respiratory rate of less than 70 on average over 24 hours for more than 24 hours
- The infant could have no significant chest recession (sternal/diaphragmatic)
Exclusion Criteria
- Evidence of a hemodynamically or clinically significant (worsening respiratory status or pulmonary edema on chest x-ray) Patent ductus arteriosus, diagnosed either clinically or echocardiographically.
- Any significant congenital abnormality (abnormalities affecting a major organ system, airway, or musculoskeletal system).
- Hemodynamic/respiratory instability or currently being treated for suspected or proven sepsis (positive blood culture)
- Grade IV intraventricular hemorrhage
- Inability to obtain informed parental consent
Data sourced from ClinicalTrials.gov (NCT02819050). 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.