N/A
N=360
NHFOV as Primary Support in Very Preterm Infants With RDS
to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates
Bottom Line
View on ClinicalTrials.gov: NCT05141435 ↗Enrolled (actual)
360
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcome: Primary: Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation — 48; 27 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- infants receive primary non-invasive respiratory support by mean of nCPAP (Procedure); infants receive primary non-invasive respiratory support by mean of NHFOV (Procedure)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Jiulongpo No.1 People's Hospital
- Primary completion
- Aug 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation |
48; 27 | — |
| SECONDARY Rate of Airleaks(Pneumothorax and/or Pneumomediastinum) Occurred During Noninvasive Respiratory Support |
4; 1 | — |
Summary
This will be a prospective, multi-center, two-arms,parallel, randomized, controlled trial with a superiority design,conducted in China. The investigators conduct this multi-centre, randomized, controlled trial to test the hypothesis that NHFOV is more effective than nCPAP in the treatment of respiratory distress syndrome (RDS) in infants with a gestational age of less than 28 weeks when used as a primary noninvasive ventilation (NIV) mode.
Eligibility Criteria
Inclusion Criteria
(1) Gestational age between 240/7 and 286/7 weeks; (2) diagnosis of RDS. The diagnosis of RDS will be based on clinical manifestations (tachypnea, nasal flaring and or grunting) and a fraction of inspired oxygen (FiO2) greater than 0.25 for target saturation of peripheral oxygen (SpO2) 89% to 94%；（3） Age less than 2 hours
Exclusion Criteria
- Intubated forany reasons at birth
- Major congenital malformations or known complex congenital heart disease
- No parental consent
Data sourced from ClinicalTrials.gov (NCT05141435). 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.