UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032047 |
|---|---|
| Receipt number | R000036561 |
| Scientific Title | Electrophysiological investigation of infants with apnea due to bronchiolitis or respiratory tract infection. |
| Date of disclosure of the study information | 2018/04/04 |
| Last modified on | 2020/10/02 16:57:02 |
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Basic information
Public title
Electrophysiological investigation of infants with apnea due to bronchiolitis or respiratory tract infection.
Acronym
Electrophysiological investigation of infants with apnea due to bronchiolitis or respiratory tract infection.
Scientific Title
Electrophysiological investigation of infants with apnea due to bronchiolitis or respiratory tract infection.
Scientific Title:Acronym
Electrophysiological investigation of infants with apnea due to bronchiolitis or respiratory tract infection.
Region
| Japan |
Condition
Condition
bronchiolitis, apnea
Classification by specialty
| Neurology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
bronchiolitis during early infancy is a risk of life-threatening apnea. the neural mechanism underlying apnea is poorly understood. we sought to identify the electrophysiological correlates of severe infantile apnea and death.
Basic objectives2
Others
Basic objectives -Others
to see if the apnea during bronchiolitis is epileptic or non-epileptic
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
electroencephalography during intensive care
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| Not applicable |
Age-upper limit
| 3 | months-old | >= |
Gender
Male and Female
Key inclusion criteria
those who underwent point-of-care electroencephalography during PICU stay.
Key exclusion criteria
those who underwent electroencephalography for reasons other than apnea evaluation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Itaru |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Child Health and Development
Division name
Neurology
Zip code
157-0074
Address
2-10-1, Okura, Setagaya-ku
TEL
0334160181
itaruhayakawa@gmail.com
Public contact
Name of contact person
| 1st name | Itaru |
| Middle name | |
| Last name | Hayakawa |
Organization
National Center for Child Health and Development
Division name
Neurology
Zip code
157-0074
Address
2-10-1, Okura, Setagayaku
TEL
0334160181
Homepage URL
itaruhayakawa@gmail.com
Sponsor or person
Institute
National Center for Child Health and Development
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Child Health and Development
Address
Tokyo
Tel
0334160181
hayakawa-i@ncchd.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 04 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/epdf/10.1111/ped.14225
Number of participants that the trial has enrolled
22
Results
This single-center pilot study investigated whether or not apnea accompanying bronchiolitis is an ictal event. In 22 infants with a respiratory infection and apnea, eight were evaluated for apneic events not explained by simple airway obstruction by electroencephalographic monitoring. None of the eight patients showed epileptic apnea. We concluded that the majority of bronchiolitis-related apnea cases in infancy are non-epileptic.
Results date posted
| 2020 | Year | 10 | Month | 02 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
not applicable
Management information
Registered date
| 2018 | Year | 04 | Month | 01 | Day |
Last modified on
| 2020 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036561
