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

Bronchiolitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02366715
• Other study ID #: 0586-14-RMC
• Status: Recruiting
• Phase: Phase 3
• First received: December 22, 2014
• Last updated: November 23, 2015
• Start date: September 2015
• Est. completion date: April 2018

Study information

• Verified date: October 2015
• Source: Rabin Medical Center
• Contact: Eran Rom, Dr.
• Phone: 00-972-3-9253775
• Email: eranrom5[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: April 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

in age interval, diagnosed with Bronchiolitis

Exclusion Criteria:

Chronic heart/lung disease, immunocompromised state

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

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.

Locations

Country	Name	City	State
Israel	Schneider Medical Center of Israel	Petah Tikva

Sponsors (1)

Lead Sponsor	Collaborator
Rabin Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	CO2 pressure	(in mmHg) measured by a transcutaneous sensor.	during the 20-40 hours of the protocol	No
Secondary	Medical interventions	Any medication given to the child during the time of the protocol including IV fluids, inhalations, diuretics.	during the 20-40 hours of the protocol	No
Secondary	Ability to take in food orally	Whether the child has been able to feed - yes or no.	during the 20-40 hours of the protocol	No
Secondary	Number of Pediatric Intensive Care Unit (PICU) admissions	Whether the child needed admission to PICU	The whole hospitalization period of the child	No