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.
Investigators
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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