Patent Ductus Arteriosus
Conditions
Interventions
SJP-0129 is given by 3 times at 24 intervals with intravenous injection.
Sponsors
Senju Pharmaceutical co.,ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Subjects with a birth weight of 500 to 1,500 grams, up to 32 weeks gestational age. 2) Less than 72 hours of age at the time of administration of SJP-0129. 3) One of the eldest infant in the case of multiple births. If he/she does not meet the eligibility criteria, the second infant will be included. 4) Written informed consent by legal representative.
Exclusion criteria
Exclusion criteria: 1) Any major congenital malformations. 2) Any hyperbilirubinemia. 3) Less than 0.6 mL/kg/hr of baseline urinary output. 4) Any bleeding tendency from puncture sites. 5) Subjects with complicated with coagulation disorder. 6) Subjects with complicated with intraventricular hemorrhage. 7) Subjects with thrombopenia. 8) Subjects with suspected necrotizing enterocolitis. 9) Any major congenital malformations and/or chromosomal anomalies. 10) Any severe congenital bacterial infection. 11) Use of maternal antenatal nonsteroidal anti-inflammatory drug (NSAID) exposure < 72 hours prior to delivery. 12) Treatment with steroid or NSAID therapy since birth. 13) Subject with unremitting shock requiring very high doses of vasopressors. 14) Subjects with expected survival less than 48 hours. 15) Participation in any other clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of infants that required rescue treatment on or prior to Study Day 14. | — |
Countries
Japan
Contacts
Public ContactShogo Sameshima
Senju Pharmaceutical co.,ltd. Regulatory Affairs & Medical Writing, Clinical Development
Outcome results
None listed