High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

NCT ID: NCT03095495

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-14
• Study Completion Date: 2024-05-28

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.

Detailed Description

Setting:

The study will be conducted between June 2017 and June 2020 in the short stay unit of the Pediatric Emergency Center (PEC) of Hamad General Hospital, the only pediatric emergency facility in the State of Qatar. Infants aged ≤3 months presenting to the unit for treatment of viral bronchiolitis with positive RSV test will be eligible for the study.

Procedure:

Eligible patients will be enrolled after obtaining written consent. For patients who consent, plain chest radiography, and nasopharyngeal swabs will be taken for RSV detection. If the patient has a positive RSV rapid antigen test, patients will be randomized in one of the study arms. Adverse effects in each group will be carefully monitored and documented.

Study Intervention:

Patients will be randomized into two treatment arms

Group 1: Early HHHFNC Group Patients in this group will be treated by using heated humidified high flow oxygen /air via nasal cannula; investigators will keep the patient on HHHFNC until he/she becomes clinically ready for discharge.

Group 2: Standard Therapy and Rescue HHHFNC Group:

patients in this group will be treated by usual therapy,investigators will use low flow nasal cannula oxygen therapy only if oxygenation needed to maintain Oxygen saturation (SpO2) ≥ 92% , if the patient deteriorate and require ICU, rescue HHHFNC will be started before admission to the ICU.

Conditions

Bronchiolitis; Respiratory Syncytial Virus (RSV)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Early use of HHHFNC

Heated Humidified High Flow Nasal Cannula

Group Type: EXPERIMENTAL

Heated Humidified High Flow Nasal Cannula

Intervention Type: 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

Standard Therapy and Rescue HHHFNC

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

Group Type: ACTIVE_COMPARATOR

Heated Humidified High Flow Nasal Cannula

Intervention Type: 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

Standard Therapy (Low Flow Nasal Cannula)

Intervention Type: DEVICE

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

Interventions

Heated Humidified High Flow Nasal Cannula

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

Intervention Type: DEVICE

Standard Therapy (Low Flow Nasal Cannula)

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

1. Gestational age less than 30 weeks.

2. Previous history of wheezing.

3. Use of steroid within 48 hours of presentation.

4. History of chronic lung disease.

5. Infants admitted directly to ICU.

6. Prior invasive or non-invasive ventilatory support.

7. Tracheostomy.

8. Nasogastric tubes in situ on admission.

9. Upper airway abnormality (like choanal atresia and midfacial anomalies).

10. Immunodeficient children.

11. History of cardiac disease, renal disease or liver disease.

12. History of neuromuscular disorder.

• Maximum Eligible Age: 3 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sidra Medicine

OTHER

Sponsor Role: collaborator

Hamad Medical Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Khalid Alansari, MD

Role: PRINCIPAL_INVESTIGATOR

Hamad Medical Corporation

Locations

Alsadd Pediatric Emergency Center

Doha, , Qatar

Countries

Qatar

Other Identifiers

16036/16

Identifier Type: -

Identifier Source: org_study_id