Clinical trial NCT03095495: High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue
Official title: Heated Humidified High Flow Nasal Cannula (HHHFNC) For Acute Moderate to Severe RSV-Bronchiolitis in Infants Younger Than 3 Months Old: Early Versus Rescue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bronchiolitis
Respiratory Syncytial Virus (RSV)
Keywords: Heated Humidified High Flow Nasal Cannula (HHHFNC)
Low Flow Nasal Cannula
Bronchiolitis
Respiratory Syncytial Virus (RSV)
Respiratory Failure
High Flow Nasal Cannula (HFNC)
Lung Diseases, Obstructive
Lead sponsor: Hamad Medical Corporation
Sponsor class: INDUSTRY
Collaborators: name: Sidra Medicine
First posted: 2017-03-29
Enrollment: 28
Sex: ALL
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The rate of Pediatric Intensive Care Unit (PICU) admissions
timeFrame: Through study completion, an average of 3 year
Secondary outcomes:
measure: Mean length of stay (LOS)
timeFrame: Through study completion, an average of 3 year
measure: Bronchiolitis Severity Score (BSS)
timeFrame: Up to 72 hours
measure: Percentage of revisit, infirmary short-stay and admission to the hospital or PICU
timeFrame: 2 weeks after discharge
measure: Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)
timeFrame: Up to 72 hours
measure: Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
timeFrame: 1 hour after starting of rescue HHHFNC
Other outcomes:
Locations:
city: Doha
country: Qatar
facility: Alsadd Pediatric Emergency Center
Study officials:
affiliation: Hamad Medical Corporation
name: Khalid Alansari, MD
role: PRINCIPAL_INVESTIGATOR
References: