Diaphragmatic swing by CPAP flow in very preterm babies
Official title: Diaphragmatic Activity During Constant or Variable Flow CPAP in Neonates: a Non-inferiority, Randomized, Alternating Treatments Trial
Run by Centre Hospitalier Intercommunal Creteil · NCT07513051 · Data updated 2026-11-12
This study tests whether constant-flow CPAP with a nasal mask works as well as variable-flow CPAP with a nasal mask for supporting breathing in preterm babies 32 weeks or earlier gestational age.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 72 Hours to 10 Weeks |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Centre Hospitalier Intercommunal Creteil Academic / other |
| Locations | 1 site (Créteil) |
| Status | Recruiting |
| Started | June 10, 2026 |
| Main results expected | June 12, 2026 |
| Study ends | December 12, 2027 |
| Registry record updated | June 23, 2026 |
| Trial ID | NCT07513051 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Neonates born at ≤32 weeks gestational age, on CPAP for more than 24 hours, with EAdi monitoring, and whose parent/legal guardian has consented.
✕Probably not a fit
Infants with frequent apnea/hypercapnic events, high FiO2 needs, ARDS, pneumothorax, nasal injuries, congenital diseases, or hemodynamic instability may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
In this NICU study, researchers compare two CPAP approaches—constant-flow and variable-flow—using diaphragmatic electrical activity (EAdi) to gauge breathing effort in premature neonates. The goal is to see if constant-flow CPAP is not worse than variable-flow CPAP in reducing respiratory effort. The trial uses EAdi monitoring to quantify effort and to inform whether one CPAP modality better supports lung recruitment and comfort. Eligible infants are ≤32 weeks gestational age, on CPAP for at least 24 hours, and equipped with EAdi catheters. The study emphasizes noninvasive, nasal-mask interfaces and ongoing safety monitoring in a tertiary hospital NICU.
Why it matters
Potential benefit: If successful, the findings could clarify which CPAP approach better supports breathing with similar comfort, potentially guiding device selection in preterm care.
How similar studies have gone: Prior work has explored CPAP modalities, but this study aims to directly compare CF-CPAP and VF-CPAP using EAdi as a primary respiratory-effort endpoint.
Who can join: the full rules
Show full inclusion / exclusion criteria
Above mentioned age limits (72 hours to 10 weeks) apply to postnatal age. Inclusion criteria apply to gestational age at birth and postmenstrual age (in weeks). Inclusion Criteria: * Neonates born at ≤ 32 weeks GA (gestational age) * Hospitalized in our tertiary hospital NICU (Neonatal intensive care unit) * Receiving CPAP since \> 24 hours at inclusion * Equipped with EAdi catheters. * Aged more than 72 hours * With parental consent * Affiliated to or benefiting from a social security system Non inclusion Criteria: * More than 1 episode of apnea / hour and/or hypercapnic acidosis (defined as pH \< 7.20 and/or pCO2 \> 65) * FiO2 \> 60% * Neonatal ARDS (acute respiratory distress syndrome) according to the Montreux definition * Pneumothorax/ pneumomediastinum * Nasal lesions contraindicating nasal noninvasive ventilation * Major congenital malformation/Chromosomopathies * Congenital neuromuscular diseases * Hemodynamic instability
Where it's running
-
Centre Hospitalier Intercommunal de Créteil
Créteil, France Recruiting
Study contacts
- Study coordinator: Xavier DURRMEYER, MD, PhD
- Email: Durrmeyer.xavier@chicreteil.fr
- Phone: 0157023468
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.