High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Sponsor

Hamad Medical Corporation (Industry)

Overall Status

Recruiting

CT.gov ID

NCT03095495

Collaborator

Sidra Medical and Research Center (Other)

350

Enrollment

Location

Arms

57.6

Anticipated Duration (Months)

6.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bronchiolitis Respiratory Syncytial Virus (RSV)	Device: Heated Humidified High Flow Nasal Cannula Device: Standard Therapy (Low Flow Nasal Cannula)	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

350 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Aug 14, 2018

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Early use of HHHFNC Heated Humidified High Flow Nasal Cannula	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
Active Comparator: Standard Therapy and Rescue HHHFNC Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU	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 Device: 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

Arm

Intervention/Treatment

Experimental: Early use of HHHFNC

Heated Humidified High Flow Nasal Cannula

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

Active Comparator: Standard Therapy and Rescue HHHFNC

Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU

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

Device: 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

Outcome Measures

Primary Outcome Measures

The rate of Pediatric Intensive Care Unit (PICU) admissions [Through study completion, an average of 3 year]
The rate of Pediatric Intensive Care Unit admissions

Secondary Outcome Measures

Mean length of stay (LOS) [Through study completion, an average of 3 year]
Geometric mean length of stay in the short stay unit
Bronchiolitis Severity Score (BSS) [Up to 72 hours]
Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU [2 weeks after discharge]
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
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) [Up to 72 hours]
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED [1 hour after starting of rescue HHHFNC]
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 3 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.