StridorPhase 3NCT02523820
Nebulized Corticosteroid for Post Extubation Stridor in Children
A Phase 3 study testing fluticasone propionate in people with Stridor, run by Ramathibodi Hospital at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Stridor
- What is being tested?
- fluticasone propionate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteThailand
- Study dates
- Jan 2015to 30 Aug 2016
- Phase
- Phase 3
- 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 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Children age between 1 month old - 18 year old who was intubated
Who cannot join
- Palliative care
- Anatomical abnormalities of airway; subglottic stenosis
- Neuromuscular disease with negative inspiratory force < - 30 mmHg
- Need positive pressure after extubation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial
The purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.
Read the detailed 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
- Conditions
- Stridor
- Being tested
- fluticasone propionate, Placebo
- Medical subject headings
- Respiratory Sounds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fluticasone propionateDrug
Also called Flixotide
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
PlaceboDrug
Also called normal saline
NSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours
| Study group | Role | What they receive |
|---|---|---|
| fluticasone propionate | Experimental | Fluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation Receives: Drug: fluticasone propionate |
| placebo | Placebo comparator | Normal saline (NSS) 4 ml nebulized after extubation Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
post-extubation stridor
patient who developed stridor after extubation within 6 hours
Measured: 6 hours
Secondary outcomes (2)
treatment failure
patient who required escalating of respiratory support such as noninvasive positive pressure ventilation or reintubation within 24 hours
Measured: 24 hour
adverse events
hyperglycemia, oral thrust or GI bleeding
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2015 (estimated)
- Study startJan 2015
- Primary completion30 May 2016
- Study completion30 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nattachai Anantasit, Ramathibodi Hospital
- Investigators
- Nattachai Anantasit, Assist Prof., Principal investigator, Ramathibodi Hospital, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02523820
- Sponsor's protocol ID
- ID10-57-18
- Status last verified
- Apr 2017
- First submitted
- 6 Aug 2015
- Last updated
- 27 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 28272175
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Corticosteroid for Post Extubation Stridor in Children: A Randomized Double Blind Controlled Trial
- ClinicalTrials.gov ID
- NCT02523820
- Acronym / sponsor ID
- ID10-57-18
- Conditions
- Stridor
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- 30 May 2016 (actual)
- Study completion
- 30 Aug 2016 (actual)
- First posted
- 14 Aug 2015 (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 purpose of this study is to evaluate the efficacy and adverse effect of nebulized corticosteroid to prevent post-extubation stridor in children.
Detailed 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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| fluticasone propionate | Experimental | Drug: fluticasone propionateFluticasone 1 mg + Normal saline (NSS) upto 4 ml nebulized after extubation |
| placebo | Placebo comparator | Drug: PlaceboNormal saline (NSS) 4 ml nebulized after extubation |
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children age between 1 month old - 18 year old who was intubated
Key exclusion criteria (4 listed)
- Palliative care
- Anatomical abnormalities of airway; subglottic stenosis
- Neuromuscular disease with negative inspiratory force < - 30 mmHg
- Need positive pressure after extubation
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 |
|---|---|---|
| fluticasone propionateAlso: FlixotideFlixotide 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 | Drug | fluticasone propionate |
| PlaceboAlso: normal salineNSS 4 ml nebulized after extubation. Record vital signs and modified Westley score at 0, 15, 30, 60 min and 2,4,6 hours | Drug | placebo |
Primary outcome
post-extubation stridor
Time frame: 6 hours
patient who developed stridor after extubation within 6 hours
2 secondary outcomes
treatment failure
Time frame: 24 hour
adverse events
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2017.
- Results publication: PubMed 28272175Prasertsan 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.
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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.
Nattachai Anantasit, Assist Prof. principal investigator
Ramathibodi Hospital, Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing fluticasone propionate in people with Stridor, run by Ramathibodi Hospital at 1 site in Thailand.
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 1 inclusion and 4 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: finished, as of the sponsor's last update on 27 Apr 2017. 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 Thailand. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
post-extubation stridor (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 NCT02523820, which also lists 1 linked publication.
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 27 Apr 2017.