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

Primary Purpose

Bronchiolitis

Status
Unknown status
Phase
Phase 3
Locations
Israel
Study Type
Interventional
Intervention
HeatedHumidifiedHighFlowNasalCannula
Sponsored by
Rabin Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bronchiolitis

Eligibility Criteria

undefined - 2 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

in age interval, diagnosed with Bronchiolitis

Exclusion Criteria:

Chronic heart/lung disease, immunocompromised state

Sites / Locations

  • Schneider Medical Center of IsraelRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

HeatedHumidifiedHighFlowNasalCannula

Arm Description

Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters

Outcomes

Primary Outcome Measures

Changes in Bronchiolitis Severity Score grade
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
(in mmHg) measured by a transcutaneous sensor.
Medical interventions
Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
Ability to take in food orally
Whether the child has been able to feed - yes or no.
Number of Pediatric Intensive Care Unit (PICU) admissions
Whether the child needed admission to PICU

Full Information

First Posted
December 22, 2014
Last Updated
November 23, 2015
Sponsor
Rabin Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02366715
Brief Title
Treatment Of Bronchiolitis With Heated Humidified High Flow Nasal Cannula - Prospective And Retrospective Research
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 Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
April 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rabin Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HeatedHumidifiedHighFlowNasalCannula
Arm Type
Experimental
Arm Description
Treatment for moderate-severe cases of Bronchiolitis while monitoring medical parameters
Intervention Type
Device
Intervention Name(s)
HeatedHumidifiedHighFlowNasalCannula
Other Intervention Name(s)
AIRVO2
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in Bronchiolitis Severity Score grade
Description
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.
Time Frame
during the 20-40 hours of the protocol
Secondary Outcome Measure Information:
Title
CO2 pressure
Description
(in mmHg) measured by a transcutaneous sensor.
Time Frame
during the 20-40 hours of the protocol
Title
Medical interventions
Description
Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.
Time Frame
during the 20-40 hours of the protocol
Title
Ability to take in food orally
Description
Whether the child has been able to feed - yes or no.
Time Frame
during the 20-40 hours of the protocol
Title
Number of Pediatric Intensive Care Unit (PICU) admissions
Description
Whether the child needed admission to PICU
Time Frame
The whole hospitalization period of the child

10. Eligibility

Sex
All
Maximum Age & Unit of Time
2 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: in age interval, diagnosed with Bronchiolitis Exclusion Criteria: Chronic heart/lung disease, immunocompromised state
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eran Rom, Dr.
Phone
00-972-3-9253775
Email
eranrom5@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Nimrod Sachs, Dr.
Phone
00-972-3-9253775
Email
nimrod_rod@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eran Rom, Dr.
Organizational Affiliation
Schneider Children Medical Center of Israel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Schneider Medical Center of Israel
City
Petah Tikva
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eran Rom, MD
Phone
+972-54-770-5626
Email
Eranr2@clalit.org.il

12. IPD Sharing Statement

Learn more about this trial

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

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