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Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies. (EPIDEX)

Primary Purpose

Children, Bronchiolitis

Status
Terminated
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
0.9% saline solution
oral betamethasone placebo
adrenaline
oral betamethasone
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Children focused on measuring randomized prospective study, complication rate, bronchiolitis, children

Eligibility Criteria

6 Weeks - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • AP-HP, Antoine Béclère Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

0.9% saline solution - oral betamethasone placebo

adrenaline - oral betamethasone

Arm Description

Control arm: 0.9% saline solution - oral betamethasone placebo

Experimental arm : adrenaline and betamethasone

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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).
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
Variation of RDAI scores before and after nebulization
Compare clinical scores of respiratory distress before/after treatment
Adverse events during the following 7 days after inclusion
Evaluate the tolerance of experimental treatment

Full Information

First Posted
October 18, 2015
Last Updated
September 11, 2017
Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France
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1. Study Identification

Unique Protocol Identification Number
NCT02586961
Brief Title
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.
Acronym
EPIDEX
Official Title
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Terminated
Why Stopped
Removal of Adrénaline lots for safety reasons.
Study Start Date
October 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
October 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris
Collaborators
Institut National de la Santé Et de la Recherche Médicale, France

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Children, Bronchiolitis
Keywords
randomized prospective study, complication rate, bronchiolitis, children

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0.9% saline solution - oral betamethasone placebo
Arm Type
Placebo Comparator
Arm Description
Control arm: 0.9% saline solution - oral betamethasone placebo
Arm Title
adrenaline - oral betamethasone
Arm Type
Experimental
Arm Description
Experimental arm : adrenaline and betamethasone
Intervention Type
Drug
Intervention Name(s)
0.9% saline solution
Intervention Description
Placebo: Nebulized 0.9% saline solution
Intervention Type
Drug
Intervention Name(s)
oral betamethasone placebo
Intervention Description
placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses
Intervention Type
Drug
Intervention Name(s)
adrenaline
Intervention Description
Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)
Intervention Type
Drug
Intervention Name(s)
oral betamethasone
Intervention Description
Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)
Primary Outcome Measure Information:
Title
Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department
Description
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
Time Frame
7 days after enrollment
Secondary Outcome Measure Information:
Title
PICU admission rate following examination in the emergency ward
Description
Estimate and compare the percentages of infants in each group requiring Pediatric Intensive Care Unit (PICU admission).
Time Frame
during the 7 days after enrollment
Title
Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion
Description
Assess whether experimental treatment reduces healing time and duration of hospitalization of infants included in the study and who have been admitted
Time Frame
7 days after enrollment
Title
Variation of RDAI scores before and after nebulization
Description
Compare clinical scores of respiratory distress before/after treatment
Time Frame
between enrollment and an average of 7 days (the end hospitalization)
Title
Adverse events during the following 7 days after inclusion
Description
Evaluate the tolerance of experimental treatment
Time Frame
7 days after enrollment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Weeks
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vincent GAJDOS
Organizational Affiliation
AP-HP, Antoine Béclère Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
AP-HP, Antoine Béclère Hospital
City
Clamart
ZIP/Postal Code
92141
Country
France

12. IPD Sharing Statement

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Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.

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