UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027018 |
|---|---|
| Receipt number | R000030979 |
| Scientific Title | Intravenous paracetamol for closure of the ductus arteriosus after premature birth |
| Date of disclosure of the study information | 2017/04/17 |
| Last modified on | 2018/06/21 19:45:29 |
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Basic information
Public title
Intravenous paracetamol for closure of the ductus arteriosus after premature birth
Acronym
Intravenous paracetamol for closure of the ductus arteriosus after premature birth
Scientific Title
Intravenous paracetamol for closure of the ductus arteriosus after premature birth
Scientific Title:Acronym
Intravenous paracetamol for closure of the ductus arteriosus after premature birth
Region
| Japan |
Condition
Condition
PDA
Classification by specialty
| Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate of safety and efficacy of paracetamol for PDA
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacologic closure of PDA
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
expanded access
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of paracetamol (dose of 15mg/kg every 6h for 3days)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Vely low birth weight infants who born from 23 to 31 weeks of gestational age and had failed and had contraindications to indomethacin therapy.
Key exclusion criteria
Infants who born less than 23weeks of gestational age or some or has some syndrome.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsumura Shun |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Pediatrics
Zip code
Address
Kamoda 1984, Kawagoe, Saitama, Japan
TEL
049-228-3400
mshun1203@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsumura Shun |
Organization
Saitama Medical Center, Saitama Medical University
Division name
Pediatrics
Zip code
Address
Kamoda 1984, Kawagoe, Saitama, Japan
TEL
049-228-3400
Homepage URL
mshun1203@yahoo.co.jp
Sponsor or person
Institute
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
Funding Source
Organization
none
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
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 | 04 | Month | 17 | 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
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
Completed
Date of protocol fixation
| 2017 | Year | 04 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 04 | Month | 17 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030979
