Clinical trial NCT02586961: Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies.
Official title: Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Children
Bronchiolitis
Keywords: randomized prospective study
complication rate
bronchiolitis
children
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Institut National de la Santé Et de la Recherche Médicale, France
First posted: 2015-10-27
Enrollment: 195
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department
timeFrame: 7 days after enrollment
Secondary outcomes:
measure: PICU admission rate following examination in the emergency ward
timeFrame: during the 7 days after enrollment
measure: Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion
timeFrame: 7 days after enrollment
measure: Variation of RDAI scores before and after nebulization
timeFrame: between enrollment and an average of 7 days (the end hospitalization)
measure: Adverse events during the following 7 days after inclusion
timeFrame: 7 days after enrollment
Other outcomes:
Locations:
city: Clamart
country: France
facility: AP-HP, Antoine Béclère Hospital
Study officials:
affiliation: AP-HP, Antoine Béclère Hospital
name: Vincent GAJDOS
role: PRINCIPAL_INVESTIGATOR
References: