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出境医 / 临床实验 / Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis (BRONCHIOLITIS)
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis (BRONCHIOLITIS)
Study Description
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 |
Study Design
| 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 |
Arms 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
|
Outcome Measures
Primary Outcome Measures :
- : 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
Eligibility Criteria
| 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
Contacts and Locations
Locations
| France | |
| Hôpital Femme Mère Enfant | |
| Bron, France, 69677 | |
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
| Principal Investigator: | Florent BAUDIN, MD | Hospices Civils de Lyon |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | July 15, 2019 | ||||
| First Posted Date | July 17, 2019 | ||||
| Last Update Posted Date | July 17, 2019 | ||||
| Actual Study Start Date | April 1, 2018 | ||||
| Actual Primary Completion Date | August 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
: 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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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures | Not Provided | ||||
| Original Secondary Outcome Measures | Not Provided | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis | ||||
| Official Title | Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors | ||||
| 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. | ||||
| Detailed Description | Not Provided | ||||
| Study Type | Observational | ||||
| Study Design | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | All children hospitalized in the pediatric intensive care unit | ||||
| Condition |
|
||||
| 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
|
||||
| Study Groups/Cohorts | 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
Intervention: Other: Incidence, management and risk factors of seizure
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
805 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | May 1, 2019 | ||||
| Actual Primary Completion Date | August 1, 2018 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | up to 90 Days (Child) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | France | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT04022486 | ||||
| Other Study ID Numbers | Bronchiolitis | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement | Not Provided | ||||
| Responsible Party | Hospices Civils de Lyon | ||||
| Study Sponsor | Hospices Civils de Lyon | ||||
| Collaborators | Not Provided | ||||
| Investigators |
|
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| PRS Account | Hospices Civils de Lyon | ||||
| Verification Date | July 2019 | ||||
