StridorBUDEXANCT02056379
Comparison Between Budesonide and Dexamethasone Treatments for Respiratory Discomfort After Extubation on Children
A study testing Budesonide and Dexamethasone in people with Stridor, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 1 month to 19 years
- Conditions the study is for
- Stridor
- What is being tested?
- Budesonide and Dexamethasone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteBrazil
- Study dates
- Mar 2014to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Instituto Israelita de Ensino e Pesquisa Albert Einstein 's (IIEP)
São Paulo, São Paulo, 05652-000
Daniela NM Medeiros, 5511873347555, daninasu@yahoo.com.br
Eduardo J Troster, 551121511233, troster@einstein.br
About this study
Official title: Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children
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.
Read the detailed description
The investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. The population will be divided in two groups: group 1 will receive inhaled budesonide and IV NS (intravenous normal saline) and group 2 will receive IV (intravenous) dexamethasone and inhaled normal saline. The study aims to analyze and compare (I would just say compare) the clinical effects of using inhaled budesonide or IV 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.
- Conditions
- Stridor
- Being tested
- Budesonide, Dexamethasone
- Keywords
- stridor, laryngitis, budesonide, dexamethasone, children
- Medical subject headings
- Respiratory Sounds, Laryngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BudesonideDrug
Also called Pulmicort
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.
DexamethasoneDrug
Also called Decadron, Hexadrol, Maxidex
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.
| Study group | Role | What they receive |
|---|---|---|
| Budesonide | Active comparator | 2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline. Receives: 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. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (6)
Number of patients with adverse events
The investigators will consider hypertension, hyperglycemia, gastrointestinal hemorrhage as adverse events of the usage of dexamethasone.
Measured: 1 day
The time frame of stridor's and respiratory discomfort's improvements
The investigators will study if budesonide has the same time frame improvement treating stridor and respiratory discomfort.
Measured: 1 hour
The number of patients that will have extubation failure at each arm
Extubation failure will be considered as a need for re-intubation during de 48 hours after extubation.
Measured: 2 days
The number of inhaled epinephrine doses used in each arms.
The inhaled epinephrine will be used as rescue therapy to absence of improvement. The number of inhaled epinephrine dosage used on each patient will be a measure of efficacy of budesonide or dexamethasone.
Measured: 2 days
The number of patients who need for non invasive mechanical ventilation or Heliox
The non invasive mechanical ventilation and Heliox are rescue therapies. The number of patients treated with those rescue therapies will be a measure of efficacy of budesonide or dexamethasone.
Measured: 2 days
The numbers of bronchoscopies
The bronchoscopy will demonstrate the non-inflammatory causes of stridor, such as: vocal cord paralysis, granuloma formation, subglottic stenosis, cricoarytenoid joint disfunction. In these cases, neither dexamethasone nor budesonide will improve clinical conditions.
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2015 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for StridorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Israelita Albert Einstein
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital M'Boi Mirim
- Responsible party
- Principal investigator, Daniela Nasu Monteiro Medeiros, Hospital Israelita Albert Einstein
- Investigators
- Daniela NM Medeiros, Principal investigator, Hospital Israelita Albert Einstein
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056379
- Sponsor's protocol ID
- 508177
- Acronym
- BUDEXA
- Status last verified
- Feb 2014
- First submitted
- 23 Jan 2014
- Last updated
- 6 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8022437Johnson 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.
PubMed 9709042Geelhoed 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.
PubMed 8649914Sinha 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.
PubMed 19736368
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Inhaled Budesonide and Intravenous Dexamethasone Treatments for Postextubation Stridor in Children
- ClinicalTrials.gov ID
- NCT02056379
- Acronym / sponsor ID
- BUDEXA / 508177
- Conditions
- Stridor
- Keywords
- stridor, laryngitis, budesonide, dexamethasone, children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Hospital Israelita Albert EinsteinUniversity, hospital or other
- Collaborators
- Hospital M'Boi Mirim
- Study start
- Mar 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 6 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The investigators propose to perform a prospective, randomized, controlled and double-blind non inferiority study enrolling 70 children with postextubation stridor. The population will be divided in two groups: group 1 will receive inhaled budesonide and IV NS (intravenous normal saline) and group 2 will receive IV (intravenous) dexamethasone and inhaled normal saline. The study aims to analyze and compare (I would just say compare) the clinical effects of using inhaled budesonide or IV 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Budesonide | Active comparator | Drug: Budesonide2 mg of nebulized budesonide at 12/12 hours and 8 cc of intravenous normal saline. |
| Dexamethasone | Active comparator | Drug: DexamethasoneThis 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. |
Who may qualify
- Ages
- 1 month to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- patients under palliative care
- presence of neuromuscular disease
- previous airway pathologies
- epiglottitis, aspiration of foreign bodies
- viral laryngitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BudesonideAlso: PulmicortThe 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. | Drug | Budesonide |
| DexamethasoneAlso: Decadron, Hexadrol, MaxidexThe 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. | Drug | Dexamethasone |
Primary outcome
The decrease of stridor and respiratory discomfort
Time frame: 6 hours
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 secondary outcomes
Number of patients with adverse events
Time frame: 1 day
The time frame of stridor's and respiratory discomfort's improvements
Time frame: 1 hour
The number of patients that will have extubation failure at each arm
Time frame: 2 days
The number of inhaled epinephrine doses used in each arms.
Time frame: 2 days
The number of patients who need for non invasive mechanical ventilation or Heliox
Time frame: 2 days
The numbers of bronchoscopies
Time frame: 2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
- Background: PubMed 8022437Klassen 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.
- Background: PubMed 9709042Johnson 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.
- Background: PubMed 8649914Geelhoed 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.
- Background: PubMed 19736368Sinha 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.
Related trials for Stridor
Active, not recruitingObservational study
Role of Upper Airway Ultrasound in Predicting Weaning Outcomes in Mechanically Ventilated Patients
Post Extubation Stridor, Upper Airway Ultrasonography
Recruiting
Predicting Post Extubation Stridor After Maxillomandibular Fixation
Stridor, Larynx Edema
RecruitingObservational study
Is High Resolution Endotracheal Tube Leak Data Indicative of the Development of Post-extubation Stridor in Children?
Post Extubation Stridor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela NM Medeiros principal investigator
Hospital Israelita Albert Einstein
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Budesonide and Dexamethasone in people with Stridor, run by Hospital Israelita Albert Einstein at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela NM Medeiros (5511973347555, daninasu@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The decrease of stridor and respiratory discomfort (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02056379, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.