Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

NCT06436222 | Not Yet Recruiting FDA Device

• 1 other identifier: 336/UN2.F1/ETIK/PPM.00.02/2024
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

Brief 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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Length of stay

  30 days

Other Outcomes (2)

• Intraventricular Hemmorhage (IVH)

  one week

• Bronchopulmonary Dysplasia (BPD)

  Within 28 days

Study Arms (2)

HVNI (Intervention Group)

OTHER

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

CPAP(Control Group)

OTHER

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

Interventions

HVNI 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); HVNI (Intervention Group)

Eligibility Criteria

• Age: 28 Weeks - 32 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

MeSH Terms

Conditions

Pulmonary Atelectasis

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Putri Maharani Tristanita Marsubrin, MD, PhD

CONTACT

+62 812-8126-640; putristanita2806@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator of Perinatology Division

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

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 31, 2024
• Study Start: May 20, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share