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Nebulized Corticosteroid for Post Extubation Stridor in Children

Primary Purpose

Stridor

Status

Completed

Phase

Phase 3

Locations

Thailand

Study Type

Interventional

Intervention

fluticasone propionate

Placebo

About this trial

This is an interventional prevention trial for Stridor

Eligibility Criteria

1 Month - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Pediatric,Ramathibodi Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

fluticasone propionate

placebo

Arm Description

Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation

Normal saline (NSS) 4 ml nebulized after extubation

Outcomes

Primary Outcome Measures

post-extubation stridor

patient who developed stridor after extubation within 6 hours

Secondary Outcome Measures

treatment failure

patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours

adverse events

hyperglycemia, oral thrust or GI bleeding

Full Information

NCT ID

NCT02523820

First Posted

August 6, 2015

Last Updated

April 25, 2017

Sponsor

Ramathibodi Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02523820

Brief Title

Nebulized Corticosteroid for Post Extubation Stridor in Children

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

May 30, 2016 (Actual)

Study Completion Date

August 30, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ramathibodi Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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

6. Conditions and Keywords

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

Stridor

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

144 (Actual)

8. Arms, Groups, and Interventions

Arm Title

fluticasone propionate

Arm Type

Experimental

Arm Description

Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation

Arm Title

placebo

Arm Type

Placebo Comparator

Arm Description

Normal saline (NSS) 4 ml nebulized after extubation

Intervention Type

Drug

Intervention Name(s)

fluticasone propionate

Other Intervention Name(s)

Flixotide

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

normal saline

Intervention Description

NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours

Primary Outcome Measure Information:

Title

post-extubation stridor

Description

patient who developed stridor after extubation within 6 hours

Time Frame

6 hours

Secondary Outcome Measure Information:

Title

treatment failure

Description

patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours

Time Frame

24 hour

Title

adverse events

Description

hyperglycemia, oral thrust or GI bleeding

Time Frame

24 hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Month

Maximum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Nattachai Anantasit, Assist Prof.

Organizational Affiliation

Ramathibodi Hospital, Mahidol University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Pediatric,Ramathibodi Hospital

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

12. IPD Sharing Statement

Citations:

PubMed Identifier

28272175

Citation

Prasertsan P, Nakju D, Lertbunrian R, Chantra M, Anantasit N. Nebulized Fluticasone for Preventing Postextubation Stridor in Intubated Children: A Randomized, Double-Blind Placebo-Controlled Trial. Pediatr Crit Care Med. 2017 May;18(5):e201-e206. doi: 10.1097/PCC.0000000000001124.

Results Reference

result

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Nebulized Corticosteroid for Post Extubation Stridor in Children

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