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

Email

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


Email

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


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 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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name