NCT04022486

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
805

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
Last Updated

July 17, 2019

Status Verified

July 1, 2019

Enrollment Period

4 months

First QC Date

July 15, 2019

Last Update Submit

July 15, 2019

Conditions

Keywords

Infant

Outcome Measures

Primary Outcomes (1)

  • : 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

Study Arms (1)

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

Interventions

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

Children admitted in the PICU for severe bronchiolitis

Eligibility Criteria

AgeUp to 90 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All children hospitalized in the pediatric intensive care unit

You may qualify if:

  • 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)

You may not qualify if:

  • neurological history that may explain the occurrence of seizures
  • significant congenital heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hôpital Femme Mère Enfant

Bron, 69677, France

Location

MeSH Terms

Conditions

BronchiolitisSeizuresHyponatremia

Interventions

IncidenceTherapeutics

Condition Hierarchy (Ancestors)

BronchitisRespiratory Tract InfectionsInfectionsBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsWater-Electrolyte ImbalanceMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

MorbidityVital StatisticsData CollectionEpidemiologic MethodsInvestigative TechniquesDemographyPopulation CharacteristicsEpidemiologic MeasurementsPublic HealthEnvironment and Public Health

Study Officials

  • Florent BAUDIN, MD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

April 1, 2018

Primary Completion

August 1, 2018

Study Completion

May 1, 2019

Last Updated

July 17, 2019

Record last verified: 2019-07

Locations