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

NCT02366715 | Unknown Phase 3

• 1 other identifier: 0586-14-RMC
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• 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.

  during the 20-40 hours of the protocol

Secondary Outcomes (4)

• CO2 pressure

  during the 20-40 hours of the protocol

• Medical interventions

  during the 20-40 hours of the protocol

• Ability to take in food orally

  during the 20-40 hours of the protocol

• Number of Pediatric Intensive Care Unit (PICU) admissions

  The whole hospitalization period of the child

Study Arms (1)

HeatedHumidifiedHighFlowNasalCannula

EXPERIMENTAL

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

Device: HeatedHumidifiedHighFlowNasalCannula

Interventions

HeatedHumidifiedHighFlowNasalCannula 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.

Also known as: AIRVO2

HeatedHumidifiedHighFlowNasalCannula

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• in age interval, diagnosed with Bronchiolitis

You may not qualify if:

• Chronic heart/lung disease, immunocompromised state

Sponsors & Collaborators

• Rabin Medical Center: lead

Study Sites (1)

Schneider Medical Center of Israel

Petah Tikva, Israel

RECRUITING

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Study Officials

• Eran Rom, Dr.

  Schneider Children Medical Center of Israel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eran Rom, Dr.

CONTACT

00-972-3-9253775; eranrom5@gmail.com

Nimrod Sachs, Dr.

CONTACT

00-972-3-9253775; nimrod_rod@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2014
• First Posted: February 19, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2017
• Study Completion: April 1, 2018
• Last Updated: November 24, 2015

Record last verified: 2015-10

Locations

IL (1)