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Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

NCT06436222 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-05-31

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Indonesia University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
32 Weeks
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-05-20
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06436222 on ClinicalTrials.gov