NCT02056379

Brief Summary

The study aims to analyze and compare the clinical effects of using inhaled budesonide or intravenous dexamethasone in the treatment of postextubation stridor on children admitted to the pediatric intensive care units at Hospital Municipal do M´Boi Mirim and Hospital Albert Einstein.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2014

Completed
14 days until next milestone

First Posted

Study publicly available on registry

February 6, 2014

Completed
23 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

February 6, 2014

Status Verified

February 1, 2014

Enrollment Period

1 year

First QC Date

January 23, 2014

Last Update Submit

February 4, 2014

Conditions

Stridor

Keywords

stridorlaryngitisbudesonidedexamethasonechildren

Outcome Measures

Primary Outcomes (1)

  • The decrease of stridor and respiratory discomfort

    The investigators will use the Downes-Raphaelly score as an objective measurement tool of degree of respiratory discomfort. The decrease of Downes-Raphaelly score will be considered as an improvement of patient condition.

    6 hours

Secondary Outcomes (6)

  • Number of patients with adverse events

    1 day

  • The time frame of stridor's and respiratory discomfort's improvements

    1 hour

  • The number of patients that will have extubation failure at each arm

    2 days

  • The number of inhaled epinephrine doses used in each arms.

    2 days

  • The number of patients who need for non invasive mechanical ventilation or Heliox

    2 days

  • +1 more secondary outcomes

Study Arms (2)

Budesonide

ACTIVE COMPARATOR

2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline.

Drug: Budesonide

Dexamethasone

ACTIVE COMPARATOR

This group will receive 0,15 mg/kg/dose of intravenous dexamethasone at 6/6 hours and 8 cc of nebulized normal saline at 12/12 hours.

Drug: Dexamethasone

Interventions

BudesonideDRUG

The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 2 mg of inhaled budesonide and 3 ml of IV normal saline. If there is an improvement the following maintenance therapy will be instituted for 48 hs and the subjects will receive 2 mg of budesonide q12hs and 3 ml of IV NS q6hs.

Also known as: Pulmicort
Budesonide
DexamethasoneDRUG

The subjects will receive a 5 ml normal saline inhalation right after extubation and will be re-evaluated in 5 to 10 minutes. The ones who develop upper airway obstruction and stridor with a Downes-Raphaelly score of 2 or higher will receive 0.5 ml/kg of inhaled epinephrine 1:1000 diluted to a final volume of 5 ml with a maximum dose of 2.5 ml in children up to 4 years and 5 ml in children with 5 years and above, as recommended by the American Academy of Pediatrics. The subjects who do not show an improvement after the epinephrine treatment will then be randomized to receive 8 ml of inhaled normal saline and 0.6 mg/kg of IV dexamethasone. The dexamethasone group will receive 8 ml of inhaled NS q12hs and 0.15 mg/kg/dose of dexamethasone q6hs.

Also known as: Decadron, Hexadrol, Maxidex
Dexamethasone

Eligibility Criteria

Age1 Month - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • patients intubated for periods longer than 24hs
  • age between 28 days and than 15 years
  • post extubation stridor must be clinically diagnosticated by a MD
  • informed consent must be obtained

You may not qualify if:

  • patients under palliative care
  • presence of neuromuscular disease
  • previous airway pathologies
  • epiglottitis, aspiration of foreign bodies
  • viral laryngitis
  • former airway surgery
  • patients previously included in the study within the same hospital admission
  • corticosteroid use in the 48hs preceding extubation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)

São Paulo, São Paulo, 05652-000, Brazil

Location

Related Publications (4)

  • Klassen TP, Feldman ME, Watters LK, Sutcliffe T, Rowe PC. Nebulized budesonide for children with mild-to-moderate croup. N Engl J Med. 1994 Aug 4;331(5):285-9. doi: 10.1056/NEJM199408043310501.

    PMID: 8022437BACKGROUND

  • Johnson DW, Jacobson S, Edney PC, Hadfield P, Mundy ME, Schuh S. A comparison of nebulized budesonide, intramuscular dexamethasone, and placebo for moderately severe croup. N Engl J Med. 1998 Aug 20;339(8):498-503. doi: 10.1056/NEJM199808203390802.

    PMID: 9709042BACKGROUND

  • Geelhoed GC, Macdonald WB. Oral and inhaled steroids in croup: a randomized, placebo-controlled trial. Pediatr Pulmonol. 1995 Dec;20(6):355-61. doi: 10.1002/ppul.1950200604.

    PMID: 8649914BACKGROUND

  • Sinha A, Jayashree M, Singhi S. Aerosolized L-epinephrine vs budesonide for post extubation stridor: a randomized controlled trial. Indian Pediatr. 2010 Apr;47(4):317-22. doi: 10.1007/s13312-010-0060-z. Epub 2009 Sep 3.

    PMID: 19736368BACKGROUND

MeSH Terms

Conditions

Respiratory SoundsLaryngitis

Interventions

BudesonideDexamethasoneCalcium Dobesilate

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsLaryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsPregnadienetriolsPregnadienesSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Officials

  • Daniela NM Medeiros

    Hospital Israelita Albert Einstein

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela NM Medeiros

CONTACT

5511973347555daninasu@yahoo.com.br

Eduardo J Troster

CONTACT

551121511233troster@einstein.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 23, 2014

First Posted

February 6, 2014

Study Start

March 1, 2014

Primary Completion

March 1, 2015

Study Completion

March 1, 2016

Last Updated

February 6, 2014

Record last verified: 2014-02

Locations

BR(1)