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Clinical Trials/JPRN-C000000160
JPRN-C000000160
Completed
Phase 3

Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants. - Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.

eonatal Research Network Japan0 sites600 target enrollmentSeptember 11, 2005

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Extremely Low Birth Weight Infants (Intraventricular Hemorrhage , Patent ductus arteriosus)
Sponsor
eonatal Research Network Japan
Enrollment
600
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
September 11, 2005
End Date
December 1, 2006
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
eonatal Research Network Japan

Eligibility Criteria

Inclusion Criteria

  • Not provided

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.

Outcomes

Primary Outcomes

Not specified

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