UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravenous paracetamol for closure of the ductus arteriosus after premature birth
Title of the study (Brief title)	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	Matsumura Shun
Organization	Saitama Medical Center, Saitama Medical University
Division name	Pediatrics
Address	Kamoda 1984, Kawagoe, Saitama, Japan
TEL	049-228-3400
Email	mshun1203@yahoo.co.jp

Public contact
Name of contact person	Matsumura Shun
Organization	Saitama Medical Center, Saitama Medical University
Division name	Pediatrics
Address	Kamoda 1984, Kawagoe, Saitama, Japan
TEL	049-228-3400
Homepage URL
Email	mshun1203@yahoo.co.jp

Sponsor
Institute	Saitama Medical Center, Saitama Medical University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 04 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030979