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Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research

This study is currently recruiting participants.
Verified October 2015 by Rabin Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT02366715
First Posted: February 19, 2015
Last Update Posted: November 24, 2015
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.
Information provided by (Responsible Party):
Rabin Medical Center
  Purpose
Bronchiolitis is an acute lower airway infection caused by a viral infection. It is a major cause of winter admissions to pediatric wards. Accepted therapies include oxygen support and IV fluids, whereas other supportive therapies such as inhalations are of questionable benefit. Moderate to severe cases are a source of distress to patient, parents and medical staff often necessitating Pediatric Intensive Care Unit admission. Heated Humidified High Flow Nasal Cannula (HHHFNC) therapy has been shown lately to improve the work of breathing, oxygen saturation, and CO2 pressure (PCO2) values as well as decrease PICU admissions and intubation rates. We planned a prospective and retrospective study in order to check the feasibility of using HHHFNC in a primary pediatric ward and its effect on clinical well being, respiratory status and PICU admission.

Condition Intervention Phase
Bronchiolitis Device: HeatedHumidifiedHighFlowNasalCannula Phase 3

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: IMLEMENTATION OF High Flow Nasal Cannulae Therapy FOR THE TREATMENT OF BRONCHIOLITIS IN A GENERAL PEDIATRIC WARD - A RETROSPECTIVE AND PROSPECTIVE CLINICAL TRIAL

Further study details as provided by Rabin Medical Center:

Primary Outcome Measures:
  • Changes in Bronchiolitis Severity Score grade [ Time Frame: during the 20-40 hours of the protocol ]
    The grade in the Bronchiolitis Severity Score (0-12) reflects a general improvement or deterioration in any of these 5 parameters - oxygen saturation, breath rate, general appearance, degree of dyspnea and lung auscultation result.


Secondary Outcome Measures:
  • CO2 pressure [ Time Frame: during the 20-40 hours of the protocol ]
    (in mmHg) measured by a transcutaneous sensor.

  • Medical interventions [ Time Frame: during the 20-40 hours of the protocol ]
    Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.

  • Ability to take in food orally [ Time Frame: during the 20-40 hours of the protocol ]
    Whether the child has been able to feed - yes or no.

  • Number of Pediatric Intensive Care Unit (PICU) admissions [ Time Frame: The whole hospitalization period of the child ]
    Whether the child needed admission to PICU


Estimated Enrollment: 200
Study Start Date: September 2015
Estimated Study Completion Date: April 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: HeatedHumidifiedHighFlowNasalCannula
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
Device: HeatedHumidifiedHighFlowNasalCannula

We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co. [3] which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.

Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.

Other Name: AIRVO2

Detailed Description:

Supportive Care, Single Group Assignment, Open Label, Non-Randomized, Efficacy Study

The research is devised as follows:

Prospective section: We will enroll children 0-2 years old, diagnosed with Bronchiolitis in our ward (Pediatrics C) during the months of November-March 2014-2016. Children will be evaluated according to a Bronchiolitis Severity Score devised by Wang and Co which was successfully used in previous research. Children answering criteria for moderate or severe Bronchiolitis according to Wang and Co. will be enrolled pending written consent by both parents.

Our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016.

Retrospective section: We will examine up to 200 cases of children aged 0-2 years hospitalized due to Bronchiolitis in Pediatrics C during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable HHHFNC etc.). We will compare clinical data and vital parameters between the groups treated with HHHFNC and those who were not.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

in age interval, diagnosed with Bronchiolitis

Exclusion Criteria:

Chronic heart/lung disease, immunocompromised state

  Contacts and Locations
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): NCT02366715


Contacts
Contact: Eran Rom, Dr. 00-972-3-9253775 eranrom5@gmail.com
Contact: Nimrod Sachs, Dr. 00-972-3-9253775 nimrod_rod@yahoo.com

Locations
Israel
Schneider Medical Center of Israel Recruiting
Petah Tikva, Israel
Contact: Eran Rom, MD    +972-54-770-5626    Eranr2@clalit.org.il   
Sponsors and Collaborators
Rabin Medical Center
Investigators
Principal Investigator: Eran Rom, Dr. Schneider Children Medical Center of Israel
  More Information

Responsible Party: Rabin Medical Center
ClinicalTrials.gov Identifier: NCT02366715     History of Changes
Other Study ID Numbers: 0586-14-RMC
First Submitted: December 22, 2014
First Posted: February 19, 2015
Last Update Posted: November 24, 2015
Last Verified: October 2015

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