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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
28
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
will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU
Alsadd Pediatric Emergency Center
Doha, Qatar
The rate of Pediatric Intensive Care Unit (PICU) admissions
The rate of Pediatric Intensive Care Unit admissions
Time frame: Through study completion, an average of 3 year
Mean length of stay (LOS)
Geometric mean length of stay in the short stay unit
Time frame: Through study completion, an average of 3 year
Bronchiolitis Severity Score (BSS)
Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours
Time frame: Up to 72 hours
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU
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
Time frame: 2 weeks after discharge
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours
Time frame: Up to 72 hours
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Time frame: 1 hour after starting of rescue HHHFNC
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