High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Hamad Medical Corporation (HMC)

Status: Completed

Conditions: Bronchiolitis; Respiratory Syncytial Virus (RSV)

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03095495

16036/16

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

Early use of HHHFNC

Experimental group

Description:

Heated Humidified High Flow Nasal Cannula

Treatment:

Device: Heated Humidified High Flow Nasal Cannula

Standard Therapy and Rescue HHHFNC

Active Comparator group

Description:

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

Treatment:

Device: Standard Therapy (Low Flow Nasal Cannula)

Device: Heated Humidified High Flow Nasal Cannula