High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

  • STATUS
    Recruiting
  • End date
    Jun 1, 2023
  • participants needed
    350
  • sponsor
    Hamad Medical Corporation
Updated on 27 February 2022

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.

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.

Details
Condition Bronchiolitis, Respiratory Syncytial Virus (RSV)
Treatment Heated Humidified High Flow Nasal Cannula, Standard Therapy (Low Flow Nasal Cannula)
Clinical Study IdentifierNCT03095495
SponsorHamad Medical Corporation
Last Modified on27 February 2022

Eligibility

Yes No Not Sure

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

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
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