Nebulized Corticosteroid for Post Extubation Stridor in Children
1 other identifier
interventional
144
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Jan 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 6, 2015
CompletedFirst Posted
Study publicly available on registry
August 14, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 30, 2016
CompletedApril 27, 2017
April 1, 2017
1.4 years
August 6, 2015
April 25, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
post-extubation stridor
patient who developed stridor after extubation within 6 hours
6 hours
Secondary Outcomes (2)
treatment failure
24 hour
adverse events
24 hour
Study Arms (2)
fluticasone propionate
EXPERIMENTALFluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation
placebo
PLACEBO COMPARATORNormal saline (NSS) 4 ml nebulized after extubation
Interventions
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
NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
Eligibility Criteria
You may qualify if:
- Children age between 1 month old - 18 year old who was intubated
You may not qualify if:
- Palliative care
- Anatomical abnormalities of airway; subglottic stenosis
- Neuromuscular disease with negative inspiratory force \< - 30 mmHg
- Need positive pressure after extubation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Pediatric,Ramathibodi Hospital
Bangkok, 10400, Thailand
Related Publications (1)
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.
PMID: 28272175RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nattachai Anantasit, Assist Prof.
Ramathibodi Hospital, Mahidol University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
August 6, 2015
First Posted
August 14, 2015
Study Start
January 1, 2015
Primary Completion
May 30, 2016
Study Completion
August 30, 2016
Last Updated
April 27, 2017
Record last verified: 2017-04