UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000160 |
|---|---|
| Receipt number | 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 16:18:14 |
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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
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/
mfuji@mch.pref.osaka.jp
Sponsor or person
Institute
Neonatal Research Network Japan
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000229
