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

• Status: Terminated
• Trial end date: 2017-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborator: Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Betamethasone; Betamethasone benzoate; Betamethasone sodium phosphate; Betamethasone Valerate; Betamethasone-17,21-dipropionate; Epinephrine; Epinephryl borate; Pharmaceutical Solutions; Racepinephrine

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