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

NCT02586961 | Terminated Phase 2

• 2 other identifiers: P1409292015-002477-38
• Study Type: interventional
• Target: 195
• Locations: 1 country
• Sites: 1

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.

Conditions

Children; Bronchiolitis

Keywords

randomized prospective study; complication rate; bronchiolitis; children

Outcome Measures

Primary Outcomes (1)

• 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

  7 days after enrollment

Secondary Outcomes (4)

• PICU admission rate following examination in the emergency ward

  during the 7 days after enrollment

• Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion

  7 days after enrollment

• Variation of RDAI scores before and after nebulization

  between enrollment and an average of 7 days (the end hospitalization)

• Adverse events during the following 7 days after inclusion

  7 days after enrollment

Study Arms (2)

0.9% saline solution - oral betamethasone placebo

PLACEBO COMPARATOR

Control arm: 0.9% saline solution - oral betamethasone placebo

Drug: 0.9% saline solution; Drug: oral betamethasone placebo

adrenaline - oral betamethasone

EXPERIMENTAL

Experimental arm : adrenaline and betamethasone

Drug: adrenaline; Drug: oral betamethasone

Interventions

0.9% saline solution DRUG

Placebo: Nebulized 0.9% saline solution

0.9% saline solution - oral betamethasone placebo

oral betamethasone placebo DRUG

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

0.9% saline solution - oral betamethasone placebo

adrenaline DRUG

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

adrenaline - oral betamethasone

oral betamethasone DRUG

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

adrenaline - oral betamethasone

Eligibility Criteria

• Age: 6 Weeks - 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• Severe distress (defined as one of following signs: a pulse rate \>200/min, respiratory rate \>80/min, RDAI score \>15, neurological disorders)
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• Institut National de la Santé Et de la Recherche Médicale, France: collaborator

Study Sites (1)

AP-HP, Antoine Béclère Hospital

Clamart, 92141, France

Location

MeSH Terms

Conditions

Bronchiolitis

Interventions

Saline Solution; Epinephrine; Betamethasone

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Biogenic Monoamines; Biogenic Amines; Catecholamines; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Vincent GAJDOS

  AP-HP, Antoine Béclère Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2015
• First Posted: October 27, 2015
• Study Start: October 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: September 12, 2017

Record last verified: 2016-10

Locations

FR (1)