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

NCT ID: NCT02366715

Last Updated: 2015-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2018-04-30

Brief Summary

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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

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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.

Conditions

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Bronchiolitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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HeatedHumidifiedHighFlowNasalCannula

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

Group Type EXPERIMENTAL

HeatedHumidifiedHighFlowNasalCannula

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

Other Intervention Names

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AIRVO2

Eligibility Criteria

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Inclusion Criteria

in age interval, diagnosed with Bronchiolitis

Exclusion Criteria

Chronic heart/lung disease, immunocompromised state
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rabin Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eran Rom, Dr.

Role: PRINCIPAL_INVESTIGATOR

Schneider Children Medical Center of Israel

Locations

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Schneider Medical Center of Israel

Petah Tikva, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Eran Rom, Dr.

Role: CONTACT

00-972-3-9253775

Nimrod Sachs, Dr.

Role: CONTACT

00-972-3-9253775

Facility Contacts

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Eran Rom, MD

Role: primary

+972-54-770-5626

Other Identifiers

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0586-14-RMC

Identifier Type: -

Identifier Source: org_study_id