UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000032047
Receipt No. 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 (Ver. 4)

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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
Email 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
Email itaruhayakawa@gmail.com

Sponsor
Institute National Center for Child Health and Development
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000036561