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Name:
UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000026774
Receipt No. R000030738
Scientific Title perinatal management of maternal SSRI and SNRI use
Date of disclosure of the study information 2017/03/31
Last modified on 2019/11/18

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Basic information
Public title perinatal management of maternal SSRI and SNRI use
Acronym H28-NHO (Development) -02
Scientific Title perinatal management of maternal SSRI and SNRI use
Scientific Title:Acronym H28-NHO (Development) -02
Region
Japan

Condition
Condition Anxiety disorder
Classification by specialty
Obsterics and gynecology Pediatrics Psychiatry
Child
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Poor neonatal adaptation of maternal SSRI, SNRI use
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes neonatal withdrawal syndrome score
Key secondary outcomes Severe poor neonatal adaptation
PPHN
neonatal oxygen use

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
0 days-old <=
Age-upper limit
28 days-old >=
Gender Male and Female
Key inclusion criteria neonates of maternal SSRI, SNRI use in third trimester of pregnancy
Key exclusion criteria no record
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name KAWADA Kou
Organization NHO Kyoto Medical Center
Division name Pediatrics
Zip code
Address Kyoto Fushimi Fukakusamukobatake 1-1
TEL 075-641-9161
Email kawada@kms.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name KAWADA Kou
Organization NHO Kyoto Medical Center
Division name Pediatrics
Zip code
Address Kyoto Fushimi Fukakusamukobatake 1-1
TEL 075-641-9161
Homepage URL
Email kawada@kms.ac.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 61
Results
Results date posted
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 Main results already published
Date of protocol fixation
2016 Year 12 Month 21 Day
Date of IRB
2017 Year 03 Month 15 Day
Anticipated trial start date
2017 Year 04 Month 01 Day
Last follow-up date
2019 Year 03 Month 31 Day
Date of closure to data entry
2019 Year 08 Month 09 Day
Date trial data considered complete
2019 Year 08 Month 09 Day
Date analysis concluded
2019 Year 11 Month 18 Day

Other
Other related information Finish

Management information
Registered date
2017 Year 03 Month 30 Day
Last modified on
2019 Year 11 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030738

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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