Nebulized Corticosteroid for Post Extubation Stridor in Children

Phase 3

Completed

• Conditions: Stridor
• Interventions: Drug: Placebo; Drug: fluticasone propionate

• Registration Number: NCT02523820
• Lead Sponsor: Ramathibodi Hospital

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

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-08-06
• Study First Submitted QC: 2015-08-12
• Study First Posted: 2015-08-14
• Primary Completion: 2016-05-30
• Study Completion: 2016-08-30
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-25
• Last Update Posted: 2017-04-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 144

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	Normal saline (NSS) 4 ml nebulized after extubation
fluticasone propionate	fluticasone propionate	Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation

Primary Outcome Measures

Name	Time	Method
post-extubation stridor	6 hours	patient who developed stridor after extubation within 6 hours

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Pediatric,Ramathibodi Hospital; 🇹🇭 Bangkok, Thailand