HVNI vs CPAP in Children With Acute Respiratory Distress

NCT07336121 | Completed

• 2 other identifiers: FMASU MD 11/2023FMASU MD 11 /2023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Acute breathing problems are a common reason for children to be admitted to the pediatric intensive care unit, and many of these children need breathing support without a breathing tube. High-Velocity Nasal Insufflation (HVNI) and nasal Continuous Positive Airway Pressure (nCPAP) are commonly used to help children breathe, but there is limited information comparing how well they work and how comfortable they are for children. This study aims to compare the clinical outcomes and tolerability of HVNI and nCPAP in children aged 1 month to 5 years with acute respiratory distress admitted to the pediatric intensive care unit, using clinical assessment and lung ultrasound findings.

Conditions

Community Acquired Pneumonia; Bronchiolitis

Keywords

High -Velocity Nasal Insufflation; Continuous positive Airway Pressure; Pediatric Acute Respiratory Distress; pediatric intensive care unit

Outcome Measures

Primary Outcomes (1)

• Improvement in lung aeration assessed by lung ultrasound score

  To compare the effectiveness of High Velocity Nasal Insufflation versus Nasal Continuous Positive Airway Pressure in improving lung aeration in children with acute respiratory distress, assessed by daily lung ultrasound score during PICU stay. The LUS ranges from 0 to 36, where higher scores indicate worse lung aeration and lower scores indicate improvement.

  At Baseline, pre procedural , 48 hours .

Secondary Outcomes (1)

• Clinical improvement of respiratory distress assessed by Modified Respiratory Distress Score

  Baseline and 48 hours after initiation of respiratory support

Study Arms (2)

High Velocity Nasal Insufflation (HVNI)

ACTIVE COMPARATOR

Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using High Velocity Nasal Insufflation after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay.

Device: High Velocity Nasal Insufflation (HVNI)

Nasal Continuous Positive Airway Pressure (Nasal CPAP)

ACTIVE COMPARATOR

Children aged 1 month to 5 years with acute respiratory distress admitted to the PICU will receive respiratory support using nasal Continuous Positive Airway Pressure after failure of low-flow oxygen therapy. Outcomes and tolerability will be assessed clinically and by daily lung ultrasound score during PICU stay.

Device: Nasal Continuous Positive Airway Pressure (Nasal CPAP)

Interventions

Nasal Continuous Positive Airway Pressure (Nasal CPAP) DEVICE

Nasal Continuous Positive Airway Pressure will be delivered via nasal interface providing continuous positive airway pressure with supplemental oxygen to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Settings will be adjusted according to clinical response and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay.

Nasal Continuous Positive Airway Pressure (Nasal CPAP)

High Velocity Nasal Insufflation (HVNI) DEVICE

High Velocity Nasal Insufflation will be delivered using a heated, humidified nasal cannula system to children aged 1 month to 5 years with acute respiratory distress who failed low-flow oxygen therapy. Therapy will be initiated and adjusted according to clinical condition and institutional PICU protocol. Patients will be monitored clinically and by daily lung ultrasound score during PICU stay.

High Velocity Nasal Insufflation (HVNI)

Eligibility Criteria

• Age: 1 Month - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children aged 1 month to 5 years
• Admitted to the Pediatric Intensive Care Unit (PICU)
• Diagnosed with acute respiratory distress
• Failure of low-flow nasal oxygen therapy
• Requiring non-invasive respiratory support
• Informed consent obtained from parent or legal guardian

You may not qualify if:

• Presence of congenital or acquired cardiac disease
• Neuromuscular disorders
• Chronic lung disease
• History of recurrent wheezing
• History of cardio-respiratory arrest
• Presence of significant comorbid chronic illness
• Contraindication to non-invasive ventilation

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Pediatric Intensive Care Units, Children Hospital, Ain shams university

Cairo, 00002, Egypt

Location

Related Publications (1)

• Liu C, Cheng WY, Li JS, Tang T, Tan PL, Yang L. High-Flow Nasal Cannula vs. Continuous Positive Airway Pressure Therapy for the Treatment of Children <2 Years With Mild to Moderate Respiratory Failure Due to Pneumonia. Front Pediatr. 2020 Nov 13;8:590906. doi: 10.3389/fped.2020.590906. eCollection 2020.

  PMID: 33304868 RESULT

Related Links

• High flow nasal cannula therapy versus continuous positive airway pressure and nasal positive pressure ventilation in infants with severe bronchiolitis: a randomized controlled trial

MeSH Terms

Conditions

Community-Acquired Pneumonia; Bronchiolitis

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Community-Acquired Infections; Infections; Pneumonia; Respiratory Tract Infections; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Tarek A. Abdelgawad, MD

  Ain Shams University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2025
• First Posted: January 13, 2026
• Study Start: January 9, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 27, 2026

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)