Randomized Controlled Trial for the Prevention of Intraventricular Hemorrhage by Indomethacin in Japanese Extremely Low Birth Weight Infants.
Phase 3
- Conditions
- Extremely Low Birth Weight Infants (Intraventricular Hemorrhage , Patent ductus arteriosus)
- Registration Number
- JPRN-C000000160
- Lead Sponsor
- eonatal Research Network Japan
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 600
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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.