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NCT04022486 Clinical Trial

Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis

Seizures Clinical Trial

— BRONCHIOLITIS  

Official title:
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04022486
Other study ID # Bronchiolitis
Secondary ID
Status Completed
Phase
First received
Last updated
Start date April 1, 2018
Est. completion date May 1, 2019

Study information
Verified date July 2019
Source Hospices Civils de Lyon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Bronchiolitis is the leading cause of pediatric intensive care unit admission in infants. Seizures during bronchiolitis may be a neurological complication of respiratory viruses but also of the treatments. The investigating team's hypothesis is that the incidence of seizures is not so so uncommon in infants hospitalized in the pediatric intensive care unit for severe bronchiolitis.

Recruitment information / eligibility
Status Completed
Enrollment 805
Est. completion date May 1, 2019
Est. primary completion date August 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A to 90 Days
Eligibility Inclusion Criteria:

- age < 90 days

- hospitalization from January 1st, 2010 to April 30th, 2018 in the Pediatric Intensive Care Unit (PICU) of pediatric hospital in Lyon

- with bronchiolitis (clinical diagnosis according to American Academy of Pediatrics)

Exclusion Criteria:

- neurological history that may explain the occurrence of seizures

- significant congenital heart disease

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• Incidence, management and risk factors of seizure
Incidence of seizure, management (treatment, paraclinical examinations) and risk factors of seizure in children admitted for severe bronchiolitis

Locations
Country Name City State
France Hôpital Femme Mère Enfant Bron

Sponsors (1)
Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary : Incidence of seizure during bronchiolitis (before or during hospitalization in the pediatric intensive care unit) Clinical or infra-clinical (diagnosed on Electroencephalography, EEG) seizure, simple or status epilepticus Day 1
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