NCT06436222

Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

Effectiveness of High Velocity Nasal Insufflation (HVNI) in Infants <32 Weeks Gestational Age(GA) or Birth Weight <1500 Grams With Moderate Respiratory Distress in Dr.Cipto Mangunkusumo Hospital

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Indonesia University · Academic / Other
• Sex: All
• Age: 28 Weeks – 32 Weeks
• Healthy volunteers: Accepted

Summary

Neonatal respiratory distress is a common problem in preterm infants. The application of CPAP is widely used in neonatal units as a primary mode of respiratory support for respiratory distress. However, discomfort, nasal injuries, and fixation difficulties have been reported as obstacles when applying CPAP. High velocity nasal insufflation (HVNI) may serve as an alternative to CPAP. Trials are needed to evaluate the effectiveness of HVNI in reducing the incidence of respiratory distress. The aim of this study is to compare the clinical effectiveness and safety of HVNI as an alternative therapy to CPAP in premature infants with moderate respiratory distress. This study is a prospective, non-inferiority, randomized, unblinded controlled trial to compare the efficacy of HVNI and CPAP. The subjects were randomly allocated to receive either HVNI or CPAP according to the study protocol. They were randomly assigned using blocks of four. The completion of HVNI therapy was determined by therapeutic failure within 72 hours following enrollment, indicated by the need for intubation.

Conditions

• Respiratory Distress, Newborn

Interventions

Type	Name	Description
DEVICE	HVNI	Preterm infants with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams. The infant has moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.

Timeline

• Start date: 2024-05-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2024-05-31
• Last updated: 2024-05-31

Regulatory

• FDA-regulated device study