High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

NCT03095495 | Completed

• 1 other identifier: 16036/16
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The enrolled RSV-bronchiolitis patients will be randomized into two arms , the early HHHFNC group and the standard therapy group with rescue HHHFNC to study the efficacy of this treatment.

Conditions

Bronchiolitis; Respiratory Syncytial Virus (RSV)

Keywords

Heated Humidified High Flow Nasal Cannula (HHHFNC); Low Flow Nasal Cannula; Bronchiolitis; Respiratory Syncytial Virus (RSV); Respiratory Failure; High Flow Nasal Cannula (HFNC); Lung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

• The rate of Pediatric Intensive Care Unit (PICU) admissions

  The rate of Pediatric Intensive Care Unit admissions

  Through study completion, an average of 3 year

Secondary Outcomes (5)

• Mean length of stay (LOS)

  Through study completion, an average of 3 year

• Bronchiolitis Severity Score (BSS)

  Up to 72 hours

• Percentage of revisit, infirmary short-stay and admission to the hospital or PICU

  2 weeks after discharge

• Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)

  Up to 72 hours

• Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED

  1 hour after starting of rescue HHHFNC

Study Arms (2)

Early use of HHHFNC

EXPERIMENTAL

Heated Humidified High Flow Nasal Cannula

Device: Heated Humidified High Flow Nasal Cannula

Standard Therapy and Rescue HHHFNC

ACTIVE COMPARATOR

Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU

Device: Heated Humidified High Flow Nasal Cannula; Device: Standard Therapy (Low Flow Nasal Cannula)

Interventions

Heated Humidified High Flow Nasal Cannula DEVICE

HHHFNC therapy is a simple to use system that delivers warm and moist air/oxygen mixture at high flow rates that generate positive airway pressure

Early use of HHHFNC; Standard Therapy and Rescue HHHFNC

Standard Therapy (Low Flow Nasal Cannula) DEVICE

will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU

Standard Therapy and Rescue HHHFNC

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Previously healthy infants with age 0-3 months and gestational age ≥30 weeks admitted to the short stay unit with RSV positive bronchiolitis and clinical severity score ≥4 on Wang clinical severity scale.

You may not qualify if:

• Gestational age less than 30 weeks.
• Previous history of wheezing.
• Use of steroid within 48 hours of presentation.
• History of chronic lung disease.
• Infants admitted directly to ICU.
• Prior invasive or non-invasive ventilatory support.
• Tracheostomy.
• Nasogastric tubes in situ on admission.
• Upper airway abnormality (like choanal atresia and midfacial anomalies).
• Immunodeficient children.
• History of cardiac disease, renal disease or liver disease.
• History of neuromuscular disorder.

Sponsors & Collaborators

• Hamad Medical Corporation: lead
• Sidra Medicine: collaborator

Study Sites (1)

Alsadd Pediatric Emergency Center

Doha, Qatar

Location

MeSH Terms

Conditions

Bronchiolitis; Respiratory Insufficiency; Lung Diseases, Obstructive

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases; Respiration Disorders

Study Officials

• Khalid Alansari, MD

  Hamad Medical Corporation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2017
• First Posted: March 29, 2017
• Study Start: August 14, 2018
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

QA (1)