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

Sponsor
Rabin Medical Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02366715
Collaborator
(none)
200
Enrollment
1
Location
1
Arm
31
Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase
  • Device: HeatedHumidifiedHighFlowNasalCannula
 Phase 3

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
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
Study Start Date :
Sep 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2017
Anticipated Study Completion Date :
Apr 1, 2018

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • AIRVO2

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Bronchiolitis Severity Score grade [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

    1. CO2 pressure [during the 20-40 hours of the protocol]

      (in mmHg) measured by a transcutaneous sensor.

    2. Medical interventions [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.

    3. Ability to take in food orally [during the 20-40 hours of the protocol]

      Whether the child has been able to feed - yes or no.

    4. Number of Pediatric Intensive Care Unit (PICU) admissions [The whole hospitalization period of the child]

      Whether the child needed admission to PICU

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 2 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    in age interval, diagnosed with Bronchiolitis

    Exclusion Criteria:

    Chronic heart/lung disease, immunocompromised state

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Schneider Medical Center of Israel Petah Tikva Israel

    Sponsors and Collaborators

    • Rabin Medical Center

    Investigators

    • Principal Investigator: Eran Rom, Dr., Schneider Children Medical Center of Israel

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Rabin Medical Center
    ClinicalTrials.gov Identifier:
    NCT02366715
    Other Study ID Numbers:
    • 0586-14-RMC
    First Posted:
    Feb 19, 2015
    Last Update Posted:
    Nov 24, 2015
    Last Verified:
    Oct 1, 2015
    Additional relevant MeSH terms:
    Bronchiolitis

    Study Results

    No Results Posted as of Nov 24, 2015