Extremely Low Birth Weight Infants (Intraventricular Hemorrhage , Patent ductus arteriosus)
Conditions
Interventions
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 co
Sponsors
Neonatal Research Network Japan
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Japan
Contacts
Public ContactFujimura Masanori
Osaka Medical Center for Maternal and Child Health President
Outcome results
None listed