BronchiolitisBRONCHIOLITISNCT04022486
Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis
An observational study of Bronchiolitis and Seizures, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages Up to 90 days
- Conditions the study is for
- Bronchiolitis, Seizures, Hyponatremia
- What is being tested?
- Incidence, management and risk factors of seizure
- How many people
- 805 participants
- Where
- 1 siteFrance
- Study dates
- 1 Apr 2018to 1 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 90 days
- All sexes
- No healthy volunteers
- Child
Study population: All children hospitalized in the pediatric intensive care unit
Who may be able to join
- 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)
Who cannot join
- neurological history that may explain the occurrence of seizures
- significant congenital heart disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Bronchiolitis, Seizures, Hyponatremia
- Being tested
- Incidence, management and risk factors of seizure
- Keywords
- Infant
- Medical subject headings
- Bronchiolitis, Seizures, Hyponatremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incidence, management and risk factors of seizureOther
Incidence of seizure, management (treatment, paraclinical examinations) and risk factors of seizure in children admitted for severe bronchiolitis
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Incidence, management and risk factors of seizure |
What is being measured
The primary outcome is the main question the study is designed to answer.
: 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
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start1 Apr 2018
- Primary completion1 Aug 2018
- Study completion1 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiolitisStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 805 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florent BAUDIN, MD, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04022486
- Sponsor's protocol ID
- Bronchiolitis
- Acronym
- BRONCHIOLITIS
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 17 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seizures in Infants Hospitalized in Pediatric Intensive Care Unit for Bronchiolitis : Description and Risk Factors
- ClinicalTrials.gov ID
- NCT04022486
- Acronym / sponsor ID
- BRONCHIOLITIS / Bronchiolitis
- Conditions
- Bronchiolitis, Seizures, Hyponatremia
- Keywords
- Infant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 805 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 May 2019 (actual)
- First posted
- 17 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children admitted in the PICU for severe bronchiolitis | – | Other: Incidence, management and risk factors of seizureChildren admitted in the Pediatric Intensive Care Unit (PICU) for severe bronchiolitis between January 1st, 2010 and April 30th, 2018 |
Who may qualify
- Ages
- Up to 90 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- All children hospitalized in the pediatric intensive care unit
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (2 listed)
- neurological history that may explain the occurrence of seizures
- significant congenital heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incidence, management and risk factors of seizureIncidence of seizure, management (treatment, paraclinical examinations) and risk factors of seizure in children admitted for severe bronchiolitis | Other | Children admitted in the PICU for severe bronchiolitis |
Primary outcome
: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florent BAUDIN, MD principal investigator
Hospices Civils de Lyon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiolitis and Seizures, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
: Incidence of seizure during bronchiolitis (before or during hospitalization in the pediatric intensive care unit) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2019.