## Protocol Section
### Identification Module
**NCT ID:** NCT06436222

**Brief Title:** Effectiveness of HVNI in Preterm Infants With Moderate Respiratory Distress

**Official Title:** 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

#### Organization Study ID Info
**ID:** 336/UN2.F1/ETIK/PPM.00.02/2024
#### Organization
**Class:** OTHER
**Full Name:** Indonesia University
### Status Module
#### Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2024-12-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-20

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-31
**Type:** ESTIMATED
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-29
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Indonesia University

#### Responsible Party

**Investigator Affiliation:** Indonesia University

**Investigator Full Name:** Dr. dr. Putri Maharani Tristanita Marsubrin, Sp. A(K)

**Investigator Title:** Principal Investigator of Perinatology Division

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**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 Module

**Conditions:**

- Respiratory Distress, Newborn

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

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

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Count:** 60

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Device: HVNI

**Label:** HVNI (Intervention Group)

**Type:** OTHER

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Device: HVNI

**Label:** CPAP(Control Group)

**Type:** OTHER

### Interventions

#### Intervention 1

**Arm Group Labels:**

- CPAP(Control Group)

- HVNI (Intervention Group)

**Description:** 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.

**Name:** HVNI

**Type:** DEVICE

### Outcomes Module

#### Other Outcomes

**Description:** 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

**Measure:** Intraventricular Hemmorhage (IVH)

**Time Frame:** one week

**Description:** 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

**Measure:** Bronchopulmonary Dysplasia (BPD)

**Time Frame:** Within 28 days

#### Primary Outcomes

**Description:** The primary outcome was treatment failure/success within 72 hours of treatment between HVNI and CPAP

**Measure:** Effectiveness of HVNI to prevent intubation within 72 hours

**Time Frame:** Intubation rates within 72 hours

#### Secondary Outcomes

**Description:** Duration from birth until discharge

**Measure:** Length of stay

**Time Frame:** 30 days

### Eligibility Module

**Eligibility Criteria:** \*\*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.

**Healthy Volunteers:** True

**Maximum Age:** 32 Weeks

**Minimum Age:** 28 Weeks

**Sex:** ALL

**Standard Ages:**

- CHILD

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** putristanita2806@yahoo.com

**Name:** Putri Maharani Tristanita Marsubrin, MD, PhD

**Phone:** +62 812-8126-640

**Role:** CONTACT

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M25869

- Name: Premature Birth

- Relevance: LOW

- As Found: Unknown

- ID: M5006

- Name: Birth Weight

- Relevance: LOW

- As Found: Unknown

- ID: M5114

- Name: Body Weight

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
