Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-20

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Respiratory Distress, Newborn

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are assigned to two groups either HVNI (intervention group) or CPAP (control group)

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HVNI (Intervention Group)

The infant was given therapy using HVNI with an initial flow of 6 L/min. Inspiratory fraction of oxygen (FiO2) started with 30% following the SpO2 target. The maximum flow is 8L/min. FiO2 can be increased by 5% until the target SpO2 is reached.

Group Type OTHER

HVNI

Intervention Type DEVICE

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.

CPAP(Control Group)

The infant was given therapy using CPAP with an initial pressure of 7 cmH20. Inspiratory fraction of oxygen (FiO2) starting with 30% following the SpO2 target.The maximum of CPAP pressure is 8 cmH2O. FiO2 can be increased by 5% until the target SpO2 is reached.

Group Type OTHER

HVNI

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Preterm infants born in Cipto Mangunkusumo Hospital with gestational age (GA) less than 32 weeks or birth weight less than 1500 grams.
* Infants with moderate respiratory distress (Downe score ≤ 6) detected within 24 hours after birth.
* Parents are willing to participate in the study.

Exclusion Criteria

* Infants with severe respiratory distress (Downe score ≥ 6) requiring invasive treatment in the form of mechanical ventilation, or apnea indicated by surfactant administration via endotracheal tube.
* Infants with contraindications to the use of non-invasive ventilation such as esophageal atresia, diaphragmatic hernia, air leak syndrome, and other conditions.
* Infants with respiratory distress due to non-pulmonary abnormalities.
* Infants with congenital metabolic disorders.
* Infants with congenital abnormalities that exacerbate respiratory distress.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes