Nebulized Corticosteroid for Post Extubation Stridor in Children

Stridor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02523820
• Other study ID #: ID10-57-18
• Status: Completed
• Phase: Phase 3
• First received: August 6, 2015
• Last updated: April 25, 2017
• Start date: January 2015
• Est. completion date: August 30, 2016

Study information

• Verified date: April 2017
• Source: Ramathibodi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 144
• Est. completion date: August 30, 2016
• Est. primary completion date: May 30, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Sounds
• Stridor

Intervention

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
• 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

Locations

Country	Name	City	State
Thailand	Department of Pediatric,Ramathibodi Hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Ramathibodi Hospital

Country where clinical trial is conducted

Thailand, 

References & 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 Mar 7. doi: 10.1097/PCC.00000 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-extubation stridor	patient who developed stridor after extubation within 6 hours	6 hours
Secondary	treatment failure	patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours	24 hour
Secondary	adverse events	hyperglycemia, oral thrust or GI bleeding	24 hour