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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Respiratory Distress, Newborn
• Intervention / Treatment: Device: HVNI

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Putri Maharani Tristanita Marsubrin, MD, PhD; Phone Number: +62 812-8126-640; Email: putristanita2806@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

**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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effectiveness of HVNI to prevent intubation within 72 hours	The primary outcome was treatment failure/success within 72 hours of treatment between HVNI and CPAP	Intubation rates within 72 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of stay	Duration from birth until discharge	30 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraventricular Hemmorhage (IVH)	The occurrence of bleeding in lateral and third or fourth ventricles characterized by hyper-attenuating fluid typically seen as layering within the ventricles in imaging studies	one week
Bronchopulmonary Dysplasia (BPD)	Prolonged need for supplemental oxygen in preterm infants after 28 days of age or after 36 weeks postmenstrual age and who do not have other conditions requiring oxygen	Within 28 days

Collaborators and Investigators

• Sponsor: Indonesia University

Study record dates

Study Major Dates

• Study Start (Estimated): May 20, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 20, 2024
• First Submitted That Met QC Criteria: May 29, 2024
• First Posted (Actual): May 31, 2024

Study Record Updates

• Last Update Posted (Actual): May 31, 2024
• Last Update Submitted That Met QC Criteria: May 29, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 336/UN2.F1/ETIK/PPM.00.02/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes