ClinicalTrials.gov
ClinicalTrials.gov Menu

High Flow Nasal Cannula Therapy in Bronchiolitis : Early vs Rescue

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03095495
Recruitment Status : Not yet recruiting
First Posted : March 29, 2017
Last Update Posted : August 11, 2017
Sponsor:
Collaborator:
Sidra Medical and Research Center
Information provided by (Responsible Party):
Hamad Medical Corporation

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) Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : January 2018
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : June 2020

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




Primary Outcome Measures :
  1. The rate of Pediatric Intensive Care Unit (PICU) admissions [ Time Frame: Through study completion, an average of 3 year ]
    The rate of Pediatric Intensive Care Unit admissions


Secondary Outcome Measures :
  1. Mean length of stay (LOS) [ Time Frame: Through study completion, an average of 3 year ]
    Geometric mean length of stay in the short stay unit

  2. Bronchiolitis Severity Score (BSS) [ Time Frame: Up to 72 hours ]
    Bronchiolitis Severity Score at 4, 8, 12, 24, 36, 48, 72 hours

  3. Percentage of revisit, infirmary short-stay and admission to the hospital or PICU [ Time Frame: 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

  4. Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) [ Time Frame: Up to 72 hours ]
    Transcutaneous Partial Pressure of Carbon Dioxide (PtcCO2) at 4,8,12,24,36,48,72 hours

  5. 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 ]
    Percentage of patients who are on the standard therapy arm and required ICU admission, but improved after the rescue HHHFNC in the ED



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 3 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095495


Contacts
Contact: Khalid Alansari, MD +974 55336166 kalansari1@hamad.qa
Contact: Maher M Najm, MD +974 33165813 dr.mmnajm@hotmail.com

Sponsors and Collaborators
Hamad Medical Corporation
Sidra Medical and Research Center
Investigators
Principal Investigator: Khalid Alansari, MD Hamad Medical Corporation

Responsible Party: Hamad Medical Corporation
ClinicalTrials.gov Identifier: NCT03095495     History of Changes
Other Study ID Numbers: 16036/16
First Posted: March 29, 2017    Key Record Dates
Last Update Posted: August 11, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Hamad Medical Corporation:
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

Additional relevant MeSH terms:
Bronchiolitis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections