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High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

Primary Purpose

Bronchiolitis, Respiratory Syncytial Virus (RSV)

Status
Unknown status
Phase
Not Applicable
Locations
Qatar
Study Type
Interventional
Intervention
Heated Humidified High Flow Nasal Cannula
Standard Therapy (Low Flow Nasal Cannula)
Sponsored by
Hamad Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis focused on measuring 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

Eligibility Criteria

undefined - 3 Months (Child)All SexesDoes not accept 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.

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.

Sites / Locations

  • Alsadd Pediatric Emergency CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early use of HHHFNC

Standard Therapy and Rescue HHHFNC

Arm Description

Heated Humidified High Flow Nasal Cannula

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

Outcomes

Primary Outcome Measures

The rate of Pediatric Intensive Care Unit (PICU) admissions
The rate of Pediatric Intensive Care Unit admissions

Secondary Outcome Measures

Mean length of stay (LOS)
Geometric mean length of stay in the short stay unit
Bronchiolitis Severity Score (BSS)
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
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)
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
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED

Full Information

First Posted
March 6, 2017
Last Updated
August 25, 2021
Sponsor
Hamad Medical Corporation
Collaborators
Sidra Medical and Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT03095495
Brief Title
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

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 14, 2018 (Actual)
Primary Completion Date
February 2023 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hamad Medical Corporation
Collaborators
Sidra Medical and Research Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
350 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Early use of HHHFNC
Arm Type
Experimental
Arm Description
Heated Humidified High Flow Nasal Cannula
Arm Title
Standard Therapy and Rescue HHHFNC
Arm Type
Active Comparator
Arm Description
Low Flow Nasal Cannula only if the patient needs oxygenation and Rescue HHHFNC if the patient needs PICU
Intervention Type
Device
Intervention Name(s)
Heated Humidified High Flow Nasal Cannula
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Standard Therapy (Low Flow Nasal Cannula)
Intervention Description
will be used only if the patient needs oxygenation and Rescue HHHFNC will be used if the patient needs PICU
Primary Outcome Measure Information:
Title
The rate of Pediatric Intensive Care Unit (PICU) admissions
Description
The rate of Pediatric Intensive Care Unit admissions
Time Frame
Through study completion, an average of 3 year
Secondary Outcome Measure Information:
Title
Mean length of stay (LOS)
Description
Geometric mean length of stay in the short stay unit
Time Frame
Through study completion, an average of 3 year
Title
Bronchiolitis Severity Score (BSS)
Description
Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours
Time Frame
Up to 72 hours
Title
Percentage of revisit, infirmary short-stay and admission to the hospital or PICU
Description
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
Title
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2)
Description
Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours
Time Frame
Up to 72 hours
Title
Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED
Description
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

10. Eligibility

Sex
All
Maximum Age & Unit of Time
3 Months
Accepts Healthy Volunteers
No
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: Gestational age less than 30 weeks. Previous history of wheezing. Use of steroid within 48 hours of presentation. History of chronic lung disease. Infants admitted directly to ICU. Prior invasive or non-invasive ventilatory support. Tracheostomy. Nasogastric tubes in situ on admission. Upper airway abnormality (like choanal atresia and midfacial anomalies). Immunodeficient children. History of cardiac disease, renal disease or liver disease. History of neuromuscular disorder.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khalid Alansari, MD
Phone
+974 55336166
Email
kalansari1@hamad.qa
First Name & Middle Initial & Last Name or Official Title & Degree
Maher M Najm, MD
Phone
+974 33165813
Email
dr.mmnajm@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Khalid Alansari, MD
Organizational Affiliation
Hamad Medical Corporation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alsadd Pediatric Emergency Center
City
Doha
Country
Qatar
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khalid Alansari, MD
First Name & Middle Initial & Last Name & Degree
Maher Najm, MD
Phone
33165813
Email
dr.mmnajm@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

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