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Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis (BRONCHIOLITIS)

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.
 
ClinicalTrials.gov Identifier: NCT04022486
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief 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.

Condition or disease Intervention/treatment
Bronchiolitis Seizures Hyponatremia Other: Incidence, management and risk factors of seizure

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Study Type : Observational
Actual Enrollment : 805 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors
Actual Study Start Date : April 1, 2018
Actual Primary Completion Date : August 1, 2018
Actual Study Completion Date : May 1, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort Intervention/treatment
Children admitted in the PICU for severe bronchiolitis
Children admitted in the Pediatric Intensive Care Unit (PICU) for severe bronchiolitis between January 1st, 2010 and April 30th, 2018
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




Primary Outcome Measures :
  1. : Incidence of seizure during bronchiolitis (before or during hospitalization in the pediatric intensive care unit) [ Time Frame: Day 1 ]
    Clinical or infra-clinical (diagnosed on Electroencephalography, EEG) seizure, simple or status epilepticus



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Ages Eligible for Study:   up to 90 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children hospitalized in the pediatric intensive care unit
Criteria

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

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): NCT04022486


Locations
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France
Hôpital Femme Mère Enfant
Bron, France, 69677
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Florent BAUDIN, MD Hospices Civils de Lyon

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT04022486    
Other Study ID Numbers: Bronchiolitis
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Infant
Additional relevant MeSH terms:
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Bronchiolitis
Seizures
Hyponatremia
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Water-Electrolyte Imbalance
Metabolic Diseases