High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Not Applicable

• Conditions: Bronchiolitis; Respiratory Syncytial Virus (RSV)
• Interventions: Device: Heated Humidified High Flow Nasal Cannula; Device: Standard Therapy (Low Flow Nasal Cannula)

• Registration Number: NCT03095495
• Lead Sponsor: Hamad Medical Corporation

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.

Study Timeline

• Study First Submitted: 2017-03-06
• Study First Submitted QC: 2017-03-28
• Study First Posted: 2017-03-29
• Study Start: 2018-08-14
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-25
• Last Update Posted: 2021-08-26
• Primary Completion: 2023-02
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 350

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early use of HHHFNC	Heated Humidified High Flow Nasal Cannula	Heated Humidified High Flow Nasal Cannula
Standard Therapy and Rescue HHHFNC	Heated Humidified High Flow Nasal Cannula	Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU
Standard Therapy and Rescue HHHFNC	Standard Therapy (Low Flow Nasal Cannula)	Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU

Primary Outcome Measures

Name	Time	Method
The rate of Pediatric Intensive Care Unit (PICU) admissions	Through study completion, an average of 3 year	The rate of Pediatric Intensive Care Unit admissions

Secondary Outcome Measures

Name	Time	Method
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU	2 weeks after discharge	Percentage of revisit, infirmary short-stay and admission to the hospital or PICU for the same illness on follow up for two weeks post discharge
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	Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Bronchiolitis Severity Score (BSS)	Up to 72 hours	Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)	Up to 72 hours	Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours
Mean length of stay (LOS)	Through study completion, an average of 3 year	Geometric mean length of stay in the short stay unit

Trial Locations

Locations (1)

Alsadd Pediatric Emergency Center; 🇶🇦 Doha, Qatar