Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Bronchiolitis
  • Respiratory Syncytial Virus (RSV)
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 3 years
Gender
Both males and females

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 bronchiolit...

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.

Tracking Information

NCT #
NCT03095495
Collaborators
Sidra Medical and Research Center
Investigators
Principal Investigator: Khalid Alansari, MD Hamad Medical Corporation