Ignite Creation Date:
2025-12-24 @ 12:20 PM
Ignite Modification Date:
2026-01-03 @ 8:16 PM
Study NCT ID:
NCT02586961
Status:
TERMINATED
Last Update Posted:
2017-09-12
First Post:
2015-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Study Overview
Official Title:
Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial
Status:
TERMINATED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Removal of Adrénaline lots for safety reasons.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EPIDEX
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.
Hypothesis: using Epinephrine-Betamethasone allows to reduce the rate of hospitalization of mild-to-severe acute viral bronchiolitis seen in pediatric emergency departments.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 2015-002477-38 | EUDRACT_NUMBER | None | View |