ChildrenPhase 2/3EPIDEXNCT02586961
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.
A Phase 2/3 study testing 0.9% saline solution, adrenaline and oral betamethasone in people with Children and Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The combined administration of high dose of oral betamethasone and nebulization of adrenaline seems to be an attractive therapeutic alternative for reducing the rate of hospitalization for acute bronchiolitis treated in the emergency department. Read more about this study
- Who is it for?
- Ages 6 weeks to 12 months
- Conditions the study is for
- Children, Bronchiolitis
- What is being tested?
- 0.9% saline solution, adrenaline and oral betamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 195 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2015to Oct 2017
- Phase
- Phase 2/3
- 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 6 weeks to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Infants aged 6 weeks to 12 months admitted in paediatric emergency
- First episode of acute bronchiolitis defined as: expiratory dyspnea with breath slowing and/or sibilants and/or crackles preceded by (or associated with) a nasopharyngitis more or less febrile
- Respiratory distress assessment index score (RDAI) of 4 to 15 after a nasopharyngeal clearance
- Agreement of at least one of the parents for his child to participate in biomedical research
- Affiliation to social security (beneficiary or entitled), except beneficiary of State medical help
Who cannot join
- Prematurity (less than 37 weeks of gestation)
- Antecedent of invasive respiratory ventilation during neonatal period
- Antecedent of lung or chronic cardiac pathology of wich rhythm disorder, acute obstructive cardiomyopathy and coronary insufficiency
- Immune deficiency
- Active viral infection (hepatitis, zona, herpes, varicella, HIV)
- Proven or suspected tuberculosis
Show all 14Show fewer
- Exposure to varicella during 15 days before inclusion
- Severe distress (defined as one of following signs: a pulse rate >200/min, respiratory rate >80/min, RDAI score >15, neurological disorders)
- Nebulization (aerosol spray) of Salbutamol or other bronchodilator treatment during the 24 hours before the inclusion
- Inhalation (spray) of Salbutamol during the preceding 24 hours
- Oral or inhaled corticosteroids during the preceding 2 weeks
- Previous episode of wheezing or ascertained diagnosis of asthma
- Hypersensitivity to one of the constituting of oral betamethasone
- Vaccination by living vaccine during the preceding 2 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial
The combined administration of high dose of oral betamethasone and nebulization of adrenaline seems to be an attractive therapeutic alternative for reducing the rate of hospitalization for acute bronchiolitis treated in the emergency department. However, it is essential to confirm the trend previously observed with this treatment before using it in current practice.
Read the detailed description
Rationale: In infancy, bronchiolitis is the most common acute infection of the lower respiratory tract and is most often caused by the respiratory syncytial virus (RSV). The current treatment of bronchiolitis is controversial. Although meta-analysis of nebulized bronchodilators or corticosteroids treatments failed to show any consistent benefits on admission rate, they remain widely used in pediatric emergency wards. A recent randomized, double-blind, placebo-controlled, clinical trial with a factorial design was conducted to determine whether treatment with nebulized epinephrine, a short course of high dose of oral Betamethasone, or both, resulted in a clinically important decrease in hospital admissions among infants with bronchiolitis who were seen in the emergency department. This study showed that infants in the epinephrine-betamethasone group were significantly less likely than those in the placebo group to be admitted by day 7 (relative risk, 0.65; 95% confidence interval, 0.45 to 0.95, P = 0.02). However, after adjustment for multiple comparisons, this result became insignificant (P = 0.07). This synergistic interaction was not anticipated but gave hope that the association nebulized epinephrine - short course of oral high dose of betamethasone might reduce the risk of hospitalization for infants who consulted pediatric emergencies for a moderate to severe acute bronchiolitis. It is therefore required to conduct a trial dedicated to this evaluation in the French population.
Hypothesis: using Epinephrine-Betamethasone allows to reduce the rate of hospitalization of mild-to-severe acute viral bronchiolitis seen in pediatric emergency departments.
- Conditions
- Children, Bronchiolitis
- Being tested
- 0.9% saline solution, oral betamethasone placebo, adrenaline, oral betamethasone
- Keywords
- randomized prospective study, complication rate, bronchiolitis, children
- Medical subject headings
- Bronchiolitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.9% saline solutionDrug
Placebo:
Nebulized 0.9% saline solution
oral betamethasone placeboDrug
placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses
adrenalineDrug
Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)
oral betamethasoneDrug
Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)
| Study group | Role | What they receive |
|---|---|---|
| 0.9% saline solution - oral betamethasone placebo | Placebo comparator | Control arm: 0.9% saline solution - oral betamethasone placebo Receives: Drug: 0.9% saline solution; Drug: oral betamethasone placebo |
| adrenaline - oral betamethasone | Experimental | Experimental arm : adrenaline and betamethasone Receives: Drug: adrenaline; Drug: oral betamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department
determine whether treatment with nebulized adrenaline (3 ml of 1:1000 solution) and a short course of oral dexamethasone (1.0 mg/kg) followed by five once-daily doses (0.6 mg/kg) results in a 10% decrease in hospital admissions among infants with mild-to-severe bronchiolitis seen in emergency departments
Measured: 7 days after enrollment
Secondary outcomes (4)
PICU admission rate following examination in the emergency ward
Estimate and compare the percentages of infants in each group requiring Pediatric Intensive Care Unit (PICU admission).
Measured: during the 7 days after enrollment
Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion
Assess whether experimental treatment reduces healing time and duration of hospitalization of infants included in the study and who have been admitted
Measured: 7 days after enrollment
Variation of RDAI scores before and after nebulization
Compare clinical scores of respiratory distress before/after treatment
Measured: between enrollment and an average of 7 days (the end hospitalization)
Adverse events during the following 7 days after inclusion
Evaluate the tolerance of experimental treatment
Measured: 7 days after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionSep 2017
- Study completionOct 2017 (estimated)
Why it stopped: Removal of Adrénaline lots for safety reasons.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ChildrenStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 195 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vincent GAJDOS, Principal investigator, AP-HP, Antoine Béclère Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02586961
- Sponsor's protocol ID
- P140929
- Other IDs
- 2015-002477-38, 2015
- Acronym
- EPIDEX
- Status last verified
- Oct 2016
- First submitted
- 18 Oct 2015
- Last updated
- 12 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02586961
- Acronym / sponsor ID
- EPIDEX / P140929
- Conditions
- Children, Bronchiolitis
- Keywords
- randomized prospective study, complication rate, bronchiolitis, children
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Removal of Adrénaline lots for safety reasons.
- Enrolment
- 195 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- Oct 2015
- Primary completion
- Sep 2017 (actual)
- Study completion
- Oct 2017 (estimated)
- First posted
- 27 Oct 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 combined administration of high dose of oral betamethasone and nebulization of adrenaline seems to be an attractive therapeutic alternative for reducing the rate of hospitalization for acute bronchiolitis treated in the emergency department. However, it is essential to confirm the trend previously observed with this treatment before using it in current practice.
Detailed description
Rationale: In infancy, bronchiolitis is the most common acute infection of the lower respiratory tract and is most often caused by the respiratory syncytial virus (RSV). The current treatment of bronchiolitis is controversial. Although meta-analysis of nebulized bronchodilators or corticosteroids treatments failed to show any consistent benefits on admission rate, they remain widely used in pediatric emergency wards. A recent randomized, double-blind, placebo-controlled, clinical trial with a factorial design was conducted to determine whether treatment with nebulized epinephrine, a short course of high dose of oral Betamethasone, or both, resulted in a clinically important decrease in hospital admissions among infants with bronchiolitis who were seen in the emergency department. This study showed that infants in the epinephrine-betamethasone group were significantly less likely than those in the placebo group to be admitted by day 7 (relative risk, 0.65; 95% confidence interval, 0.45 to 0.95, P = 0.02). However, after adjustment for multiple comparisons, this result became insignificant (P = 0.07). This synergistic interaction was not anticipated but gave hope that the association nebulized epinephrine - short course of oral high dose of betamethasone might reduce the risk of hospitalization for infants who consulted pediatric emergencies for a moderate to severe acute bronchiolitis. It is therefore required to conduct a trial dedicated to this evaluation in the French population.
Hypothesis: using Epinephrine-Betamethasone allows to reduce the rate of hospitalization of mild-to-severe acute viral bronchiolitis seen in pediatric emergency departments.
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 |
|---|---|---|
| 0.9% saline solution - oral betamethasone placebo | Placebo comparator | Drug: 0.9% saline solution, Drug: oral betamethasone placeboControl arm: 0.9% saline solution - oral betamethasone placebo |
| adrenaline - oral betamethasone | Experimental | Drug: adrenaline, Drug: oral betamethasoneExperimental arm : adrenaline and betamethasone |
Who may qualify
- Ages
- 6 weeks to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants aged 6 weeks to 12 months admitted in paediatric emergency
- First episode of acute bronchiolitis defined as: expiratory dyspnea with breath slowing and/or sibilants and/or crackles preceded by (or associated with) a nasopharyngitis more or less febrile
- Respiratory distress assessment index score (RDAI) of 4 to 15 after a nasopharyngeal clearance
- Agreement of at least one of the parents for his child to participate in biomedical research
- Affiliation to social security (beneficiary or entitled), except beneficiary of State medical help
Key exclusion criteria (14 listed)
- Prematurity (less than 37 weeks of gestation)
- Antecedent of invasive respiratory ventilation during neonatal period
- Antecedent of lung or chronic cardiac pathology of wich rhythm disorder, acute obstructive cardiomyopathy and coronary insufficiency
- Immune deficiency
- Active viral infection (hepatitis, zona, herpes, varicella, HIV)
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 |
|---|---|---|
| 0.9% saline solutionPlacebo: Nebulized 0.9% saline solution | Drug | 0.9% saline solution - oral betamethasone placebo |
| oral betamethasone placeboplacebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses | Drug | 0.9% saline solution - oral betamethasone placebo |
| adrenalineCatecholamine nebulized adrenaline (3 ml of 1:1000 solution) | Drug | adrenaline - oral betamethasone |
| oral betamethasoneMineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg) | Drug | adrenaline - oral betamethasone |
Primary outcome
Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department
Time frame: 7 days after enrollment
determine whether treatment with nebulized adrenaline (3 ml of 1:1000 solution) and a short course of oral dexamethasone (1.0 mg/kg) followed by five once-daily doses (0.6 mg/kg) results in a 10% decrease in hospital admissions among infants with mild-to-severe bronchiolitis seen in emergency departments
4 secondary outcomes
PICU admission rate following examination in the emergency ward
Time frame: during the 7 days after enrollment
Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion
Time frame: 7 days after enrollment
Variation of RDAI scores before and after nebulization
Time frame: between enrollment and an average of 7 days (the end hospitalization)
Adverse events during the following 7 days after inclusion
Time frame: 7 days after enrollment
Results and safety
The study was stopped early (reason given: Removal of Adrénaline lots for safety reasons.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2017.
Related trials for Children
Enrolling by invitationPhase 3
An Open-Label Study to Assess the Long-Term Safety of Solriamfetol in Children and Adolescents With ADHD
ADHD
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
RecruitingObservational study
Population Pharmacokinetics of Temocillin in Acute Enterobacterial Pyelonephritis in Children
Pyelonephritis
RecruitingObservational study
A Study in Children and, Adults With Congenital Thrombotic Thrombocytopenic Purpura (cTTP) Treated With Adzynma
Thrombotic Thrombocytopenic Purpura (TTP)
RecruitingPhase 1
Cannabidiol (CBD) in Adults With ASD
Autism Spectrum Disorder
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.
Vincent GAJDOS principal investigator
AP-HP, Antoine Béclère Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 0.9% saline solution, adrenaline and oral betamethasone in people with Children and Bronchiolitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 5 inclusion and 14 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: stopped early, as of the sponsor's last update on 12 Sep 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 France. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Removal of Adrénaline lots for safety reasons.). Results are not available in the source record.
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?
Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department (time frame: 7 days after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Sep 2017.