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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN C000000160
Receipt No. R000000229
Scientific Title Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Date of disclosure of the study information 2005/09/11
Last modified on 2006/09/20

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Basic information
Public title Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Acronym Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Scientific Title Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Scientific Title:Acronym Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Region
Japan

Condition
Condition Extremely Low Birth Weight Infants
(Intraventricular Hemorrhage , Patent ductus arteriosus)
Classification by specialty
Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To study the efficacy and complications of low dose IND with six hours' continuous infusion started within 6 hours after birth in the reduction of severe IVH in Japanese ELBW infants.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase III

Assessment
Primary outcomes 1. Incidence of grade 3, 4 Intraventricular hemorrhage on day 6.
2. Incidence of Patent ductus arteriosus on day 6.
3. Incidence of Periventricular Leukomalacia, Necrotizing Enterocolitis, Retinopathy of prematurity
Key secondary outcomes 1.Developmental impairment at 1 and a half year old.
2.Developmental impairment at 3 years of age.
3.Mortality rate at 0-27 days after birth.
4.Requirement of surgery for Patent ductus arteriosus.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A dose of intravenous injection of 0.1 mg /kg of indomethacin will be given continuously in 6 hours. Two additional dose will be given in the same manner in every 24 hours. Administration will be completed when the third administration is completed.
Interventions/Control_2 Placebo (A same dose of intravenous indomethacin of 0.1 mg /kg) will be given continuously in 6 hours. Two additional dose will be given in the same manner in every 24 hours. Administration will be completed when the third administration is completed.
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 weeks-old <=
Age-upper limit
0 weeks-old >=
Gender Male and Female
Key inclusion criteria 1.Extremely low birth weight infants weighing more than 400 g and less than 1000 g at birth.
2.Gestation above 22 weeks 0 day at birth.
3.Birth weight standard deviation -1.99 sd. All infants born less than 24 weeks 0 day is to be included.
4.First dose to be given within 6 hours of birth.
5.Informed consent to participate to the study is obtained from the guardians.
Key exclusion criteria 1. Subjects diagnosed as grade 3 and 4 Intraventricular hemorrhage.
2. Subjects with Patent ductus arteriosus which requires the usual treatment.
3.Subjects with hemorrhage tendency.
4.Subjects with platelet count < 50,000/mm3.
5.Subjects with necrotizing enterocolitis
6.Subjects with significant birth defects.
7.Subjects with mother given indomethacin or PG inhibitor within 48hours before delivery
8. Subjects judged by the investigator to be inappropriate as study subjects.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Fujimura Masanori
Organization Osaka Medical Center for Maternal and Child Health
Division name President
Zip code
Address 840, Murodocho, Izumi, Osaka, Japan
TEL 0725-56-1220
Email

Public contact
Name of contact person
1st name
Middle name
Last name Fujimura Masanori
Organization Osaka Medical Center for Maternal and Child Health
Division name President
Zip code
Address 840, Murodocho, Izumi, Osaka, Japan
TEL 0725-56-1220
Homepage URL http://nrn.shiga-med.ac.jp/
Email mfuji@mch.pref.osaka.jp

Sponsor
Institute Neonatal Research Network Japan
Institute
Department

Funding Source
Organization Government
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

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
2005 Year 09 Month 11 Day

Related information
URL releasing protocol http://nrn.shiga-med.ac.jp/indo/
Publication of results Unpublished

Result
URL related to results and publications http://nrn.shiga-med.ac.jp/
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 No longer recruiting
Date of protocol fixation
1999 Year 10 Month 05 Day
Date of IRB
Anticipated trial start date
1999 Year 11 Month 01 Day
Last follow-up date
2006 Year 12 Month 01 Day
Date of closure to data entry
2007 Year 05 Month 01 Day
Date trial data considered complete
2007 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 09 Month 11 Day
Last modified on
2006 Year 09 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000229

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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