High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03095495
• Other study ID #: 16036/16
• Status: Recruiting
• Phase: N/A
• Start date: August 14, 2018
• Est. completion date: June 2023

Study information

• Verified date: August 2021
• Source: Hamad Medical Corporation
• Contact: Khalid Alansari, MD
• Phone: +974 55336166
• Email: kalansari1[@]hamad.qa
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: June 2023
• Est. primary completion date: February 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiolitis
• Respiratory Syncytial Virus (RSV)

Intervention

Device:
• Heated Humidified High Flow Nasal Cannula
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
• Standard Therapy (Low Flow Nasal Cannula)
will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU

Locations

Country	Name	City	State
Qatar	Alsadd Pediatric Emergency Center	Doha

Sponsors (2)

Lead Sponsor	Collaborator
Hamad Medical Corporation	Sidra Medical and Research Center

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Pediatric Intensive Care Unit (PICU) admissions	The rate of Pediatric Intensive Care Unit admissions	Through study completion, an average of 3 year
Secondary	Mean length of stay (LOS)	Geometric mean length of stay in the short stay unit	Through study completion, an average of 3 year
Secondary	Bronchiolitis Severity Score (BSS)	Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours	Up to 72 hours
Secondary	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	2 weeks after discharge
Secondary	Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)	Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours	Up to 72 hours
Secondary	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	1 hour after starting of rescue HHHFNC