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

NCT ID: NCT02586961

Last Updated: 2017-09-12

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 195 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2017-10-31

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.

Conditions

Children; Bronchiolitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

0.9% saline solution - oral betamethasone placebo

Control arm: 0.9% saline solution - oral betamethasone placebo

Group Type: PLACEBO_COMPARATOR

0.9% saline solution

Intervention Type: DRUG

Placebo:

Nebulized 0.9% saline solution

oral betamethasone placebo

Intervention Type: DRUG

placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses

adrenaline - oral betamethasone

Experimental arm : adrenaline and betamethasone

Group Type: EXPERIMENTAL

adrenaline

Intervention Type: DRUG

Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)

oral betamethasone

Intervention Type: DRUG

Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)

Interventions

0.9% saline solution

Placebo:

Nebulized 0.9% saline solution

Intervention Type: DRUG

oral betamethasone placebo

placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses

Intervention Type: DRUG

adrenaline

Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)

Intervention Type: DRUG

oral betamethasone

Mineralocorticoid: a short course of oral betamethasone: 1.0 mg/kg at inclusion, followed by five once-daily doses (0.6 mg/kg)

Intervention Type: DRUG

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

• Minimum Eligible Age: 6 Weeks
• Maximum Eligible Age: 12 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut National de la Santé Et de la Recherche Médicale, France

OTHER_GOV

Sponsor Role: collaborator

Assistance Publique - Hôpitaux de Paris

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vincent GAJDOS

Role: PRINCIPAL_INVESTIGATOR

AP-HP, Antoine Béclère Hospital

Locations

AP-HP, Antoine Béclère Hospital

Clamart, , France

Countries

France

Other Identifiers

2015-002477-38

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

P140929

Identifier Type: -

Identifier Source: org_study_id