N/A
N=100
Extending CPAP Therapy in Stable Preterm Infants to Increase Lung Growth and Function
Neonatal · Premature Birth · Respiratory Distress Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT04295564 ↗Enrolled (actual)
100
Serious AEs
2.0%
Results posted
Aug 2025
Primary outcome: Primary: Alveolar Volume — 500.2; 418.1 mL — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Additional 2 weeks of CPAP (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Cynthia McEvoy
- Primary completion
- Sep 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Alveolar Volume |
500.2; 418.1 | <0.05 sig |
| SECONDARY Lung Diffusion |
3.4; 2.8 | <0.02 sig |
| SECONDARY Forced Expiratory Flows at 50% of the Expired Volume (FEF50) |
500.6; 437.9 | <0.05 sig |
Summary
This is a study to see if an extra 2 weeks of continuous positive airway pressure (CPAP) in stable preterm infants in the neonatal intensive care unit (NICU) can cause increased lung growth and lung function in the infants as measured at 6 months of age by pulmonary function testing.
Eligibility Criteria
Inclusion Criteria
- Infants born at >24 to ≤ 32 weeks gestation
- Treated with CPAP for ≥ 24 hours for respiratory distress (either as initial therapy or following extubation)
Exclusion Criteria
- Significant congenital heart disease
- Major malformations
- Chromosomal anomalies
- Culture proven sepsis at consent
- Complex maternal medical conditions
- Clinical instability
- Multiple gestations > twins
- 97th percentile for weight85
- Participating in another neonatal randomized clinical trial with a competing outcome
- Mother/legal guardian without stable method of communication
Data sourced from ClinicalTrials.gov (NCT04295564). 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.