Comparing High Flow Nasal Cannulas and CPAP for Breathing Support in Children
Impact of Increasing Flow Rates in High-flow Nasal Cannula and CPAP on Diaphragmatic Work in Newborn and Paediatric Population: Non-inferiority Study
This study is testing whether High Flow Nasal Cannulas or CPAP works better for helping babies and young children with breathing problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 34 Weeks to 6 Years |
| Sex | All |
| Sponsor | University Hospital, Clermont-Ferrand Academic / other |
| Locations | 1 site (Clermont-Ferrand) |
| Trial ID | NCT06249009 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of High Flow Nasal Cannulas (HFNC) and Continuous Positive Airways Pressure (CPAP) in providing respiratory support to neonates and children weighing less than 20 kg with respiratory failure. Participants will receive different flow rates of HFNC and CPAP, and the study will analyze diaphragmatic contraction through electrical activity measurements. The trial will also assess clinical tolerance, safety, and the incidence of side effects associated with both methods. By using a cross-over design, each participant will experience both interventions, allowing for a direct comparison of their effectiveness.
Who should consider this trial
Good fit: Ideal candidates include newborns over 34 weeks' amenorrhea and pediatric patients under 20 kg who require non-invasive ventilatory support.
Not a fit: Patients requiring immediate intubation or those with specific contraindications to HFNC or CPAP will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a less invasive and equally effective alternative to CPAP for managing respiratory failure in young patients.
How similar studies have performed: Previous studies have explored similar non-invasive ventilation methods, but this specific comparison of HFNC and CPAP in this pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Newborns over 34 SA and paediatric patients weighing less than 20 kg. * Need for ventilatory support by HFNC or CPAP for respiratory failure * Need for enteral feeding via nasogastric tube * Hospitalized in PICU or NICU at Clermont-Ferrand University Hospital, * Covered by Social Security. * Whose parents or guardians are able to provide informed consent to participate in the research. Exclusion Criteria: * Respiratory failure requiring immediate intubation. * Use of HFNC or CPAP as a relay to extubation. * Acquired or congenital abnormality of the gastrointestinal tract. * Diaphragmatic paralysis and/or neuromuscular pathology * Failure of central ventilatory control (e.g. intra-ventricular haemorrhage, anoxic-ischaemic encephalopathy, massive vascular accident, intracranial process, cerebral edema and/or intracranial hypertension). * Contraindications listed in the CPAP and HFNC user manuals: absence of spontaneous ventilation, choanal atresia, diaphragmatic hernia, tracheo-oesophageal fistula, nasal trauma, severe deformity likely to be aggravated by the nasal mask or nasal cannula, pneumothorax, pneumencephaly, Cerebrospinal Fluid leak, hypotension. * Refusal by parents or guardians.
Where this trial is running
Clermont-Ferrand
- CHU Clermont-Ferrand — Clermont-Ferrand, France (Recruiting)
Study contacts
- Principal investigator: Nadia Savy — University Hospital, Clermont-Ferrand
- Study coordinator: Lise Laclautre
- Email: promo_interne_drci@chu-clermontferrand.fr
- Phone: 334.73.754.963
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.