CompletedNot Applicable

NHFOV as Primary Support in Very Preterm Infants With RDS

China360 participantsStarted 2022-08-01

Plain-language 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.

Who can participate

Age range0 Hours – 2 Hours

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Treatment Failure Within 72 Hours After Randomization 72 Hours After Randomization Need for Invasive Mechanical Ventilation

Timeframe: within 72 hrs from the beginning of the study mode

Trial details

NCT IDNCT05141435

SponsorJiulongpo No.1 People's Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-08-05

Results submitted2024-08-13

View on ClinicalTrials.gov More to Test the Hypothesis That NHFOV is More Effective Than nCPAP in the Treatment of Respiratory Distress Syndrome (RDS) in Verypreterm Neonates trials