Nebulized Corticosteroid for Post Extubation Stridor in Children

April 25, 2017 updated by: Nattachai Anantasit, Ramathibodi Hospital

Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial

The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The guideline for prevention and treatment of post-extubation stridor in children is inconclusive include Nebulized epinephrine and intravenous corticosteroid. Nebulized corticosteroid is alternative treatment for viral croup. the rationale of this study to evaluate the efficacy of nebulized fluticasone propionate to prevent pediatric post-extubation stridor

Study Type

Interventional

Enrollment (Actual)

144

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand, 10400
        • Department of Pediatric,Ramathibodi Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children age between 1 month old - 18 year old who was intubated

Exclusion Criteria:

  • Palliative care
  • Anatomical abnormalities of airway; subglottic stenosis
  • Neuromuscular disease with negative inspiratory force < - 30 mmHg
  • Need positive pressure after extubation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fluticasone propionate
Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation
Drug: fluticasone propionate
Flixotide 1 mg + NSS upto 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
Other Names:
  • Flixotide
Placebo Comparator: placebo
Normal saline (NSS) 4 ml nebulized after extubation
Drug: Placebo
NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
Other Names:
  • normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-extubation stridor
Time Frame: 6 hours
patient who developed stridor after extubation within 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
treatment failure
Time Frame: 24 hour
patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours
24 hour
adverse events
Time Frame: 24 hour
hyperglycemia, oral thrust or GI bleeding
24 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ramathibodi Hospital

Investigators

  • Principal Investigator: Nattachai Anantasit, Assist Prof., Ramathibodi Hospital, Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

May 30, 2016

Study Completion (Actual)

August 30, 2016

Study Registration Dates

First Submitted

August 6, 2015

First Submitted That Met QC Criteria

August 12, 2015

First Posted (Estimate)

August 14, 2015

Study Record Updates

Last Update Posted (Actual)

April 27, 2017

Last Update Submitted That Met QC Criteria

April 25, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID10-57-18

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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