HVNI vs CPAP in Children With Acute Respiratory Distress

NCT ID: NCT07336121

Last Updated: 2026-01-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-09
• Study Completion Date: 2024-12-01

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.

Detailed Description

Acute respiratory distress represents a major cause of morbidity and mortality in infants and young children and accounts for a significant proportion of pediatric intensive care unit admissions. A considerable number of affected children fail conventional low-flow oxygen therapy and require escalation to non-invasive respiratory support.

High Velocity Nasal Insufflation delivers heated and humidified oxygen at high flow rates through nasal cannulae and may improve oxygenation by washing out nasopharyngeal dead space, reducing inspiratory resistance, and providing a degree of positive end-expiratory pressure. Nasal Continuous Positive Airway Pressure delivers a continuous distending airway pressure with supplemental oxygen, improving lung recruitment, reducing atelectasis, and enhancing ventilation-perfusion matching.

Both modalities are commonly used in pediatric intensive care practice; however, evidence comparing their clinical effectiveness, tolerability, and impact on lung aeration in young children remains inconclusive. Lung ultrasound has emerged as a reliable, non-invasive bedside tool for assessment of lung aeration and disease severity in critically ill children.

This prospective interventional study will enroll 80 children aged 1 month to 5 years admitted to the pediatric intensive care unit with acute respiratory distress who have failed low-flow oxygen therapy. Patients will be randomized into two groups: one group receiving High Velocity Nasal Insufflation and the other receiving nasal Continuous Positive Airway Pressure. All patients will undergo daily clinical assessment and lung ultrasound scoring during their pediatric intensive care unit (PICU) stay. Tolerability will be evaluated using the FLACC (Face, Legs, Activity, Cry, Consolability) pain scale.

The primary outcome is improvement in lung aeration as assessed by lung ultrasound score. Secondary outcomes include assessment of clinical response to therapy based on respiratory rate, oxygen saturation (SpO₂), and need for escalation of respiratory support . The results of this study aim to provide evidence to guide selection of optimal non-invasive respiratory support in children with acute respiratory distress.

Conditions

Community Acquired Pneumonia; Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

High Velocity Nasal Insufflation (HVNI)

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.

Group Type: ACTIVE_COMPARATOR

High Velocity Nasal Insufflation (HVNI)

Intervention Type: 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.

Nasal Continuous Positive Airway Pressure (Nasal CPAP)

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.

Group Type: ACTIVE_COMPARATOR

Nasal Continuous Positive Airway Pressure (Nasal CPAP)

Intervention Type: 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.

Interventions

High Velocity Nasal Insufflation (HVNI)

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.

Intervention Type: DEVICE

Nasal Continuous Positive Airway Pressure (Nasal CPAP)

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ain Shams University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tarek A. Abdelgawad, MD

Role: PRINCIPAL_INVESTIGATOR

Ain Shams University

Locations

Pediatric Intensive Care Units, Children Hospital, Ain shams university

Cairo, , Egypt

Countries

Egypt

References

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.

Reference Type: RESULT

PMID: 33304868 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

https://pubmed.ncbi.nlm.nih.gov/34909101/

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

Other Identifiers

FMASU MD 11 /2023

Identifier Type: OTHER

Identifier Source: secondary_id

FMASU MD 11/2023

Identifier Type: -

Identifier Source: org_study_id