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

July 15, 2019 updated by: Hospices Civils de Lyon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

805

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Bron, France, 69677
        • Hôpital Femme Mère Enfant

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 2 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All children hospitalized in the pediatric intensive care unit

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
: 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
Day 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Florent Baudin, MD, Hospices Civils de Lyon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2018

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

May 1, 2019

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 15, 2019

First Posted (Actual)

July 17, 2019

Study Record Updates

Last Update Posted (Actual)

July 17, 2019

Last Update Submitted That Met QC Criteria

July 15, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Bronchiolitis

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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