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Completed

NCT Number: NCT02523820

Nebulized Corticosteroid for Post Extubation Stridor in Children

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

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Key information

Conditions

Stridor Pathological Conditions, Signs and Symptoms Respiratory Sounds Signs and Symptoms Signs and Symptoms, Respiratory

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluticasone propionate

Drug

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

Drug

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

Primary outcomes

  1. post-extubation stridor

    Time frame: 6 hours

    patient who developed stridor after extubation within 6 hours

Secondary outcomes

  1. treatment failure

    Time frame: 24 hour

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

  2. adverse events

    Time frame: 24 hour

    hyperglycemia, oral thrust or GI bleeding

Sponsors and collaborators

Lead sponsor

Ramathibodi Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Aug 14, 2015
Registry last updated
Apr 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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