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

This study has been terminated.
(Removal of Adrénaline lots for safety reasons.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT02586961
First Posted: October 27, 2015
Last Update Posted: September 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Institut National de la Santé Et de la Recherche Médicale, France
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
  Purpose
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.

Condition Intervention Phase
Children Bronchiolitis Drug: 0.9% saline solution Drug: oral betamethasone placebo Drug: adrenaline Drug: oral betamethasone Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Nebulized Adrenalin and Oral Betamethasone in Children With Bronchiolitis Attending Pediatric Emergencies : a Multicentre Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • Hospital admission up to 7 days after enrollment, which occurred during the visit in the emergency department [ Time Frame: 7 days after enrollment ]
    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


Secondary Outcome Measures:
  • PICU admission rate following examination in the emergency ward [ Time Frame: during the 7 days after enrollment ]
    Estimate and compare the percentages of infants in each group requiring Pediatric Intensive Care Unit (PICU admission).

  • Length of hospitalization for infants admitted for bronchiolitis in the following 7 days after inclusion [ Time Frame: 7 days after enrollment ]
    Assess whether experimental treatment reduces healing time and duration of hospitalization of infants included in the study and who have been admitted

  • Variation of RDAI scores before and after nebulization [ Time Frame: between enrollment and an average of 7 days (the end hospitalization) ]
    Compare clinical scores of respiratory distress before/after treatment

  • Adverse events during the following 7 days after inclusion [ Time Frame: 7 days after enrollment ]
    Evaluate the tolerance of experimental treatment


Enrollment: 195
Study Start Date: October 2015
Estimated Study Completion Date: October 2017
Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 0.9% saline solution - oral betamethasone placebo
Control arm: 0.9% saline solution - oral betamethasone placebo
Drug: 0.9% saline solution

Placebo:

Nebulized 0.9% saline solution

Drug: oral betamethasone placebo
placebo of oral betamethasone: equivalent of 1 mg/kg at inclusion followed by five once-daily doses
Experimental: adrenaline - oral betamethasone
Experimental arm : adrenaline and betamethasone
Drug: adrenaline
Catecholamine nebulized adrenaline (3 ml of 1:1000 solution)
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)

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

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Weeks to 12 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02586961


Locations
France
AP-HP, Antoine Béclère Hospital
Clamart, France, 92141
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Institut National de la Santé Et de la Recherche Médicale, France
Investigators
Principal Investigator: Vincent GAJDOS AP-HP, Antoine Béclère Hospital
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT02586961     History of Changes
Other Study ID Numbers: P140929
2015-002477-38 ( EudraCT Number )
First Submitted: October 18, 2015
First Posted: October 27, 2015
Last Update Posted: September 12, 2017
Last Verified: October 2016

Keywords provided by Assistance Publique - Hôpitaux de Paris:
randomized prospective study
complication rate
bronchiolitis
children

Additional relevant MeSH terms:
Emergencies
Bronchiolitis
Disease Attributes
Pathologic Processes
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Pharmaceutical Solutions
Betamethasone benzoate
Betamethasone-17,21-dipropionate
Betamethasone
Betamethasone Valerate
Betamethasone sodium phosphate
Epinephrine
Racepinephrine
Epinephryl borate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents