Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)(WS)(ISNHP)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hyperbilirubinemia
- Sponsor
- InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
- Enrollment
- 55
- Primary Endpoint
- NEUROLOGICAL EXAMINATION; Child Behavior Check List
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
The purpose of this protocol is to provide a mechanism to collect Long Term Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion".
Detailed Description
The purpose of this protocol is to provide a mechanism to collect Clinical Data from those babies who participated in the primary Study 64,185-06-2(W)(WS)(ISNHP) "An Open-Label Study Of The Safety And Clinical Pharmacology Of Stanate® In Infants At-Risk For Exchange Transfusion". Data on long-term impact of Stannsoporfin on the physical, neurological, neurodevelopmental, biochemical, metabolic and hematopoietic profiles of the children will be collected at 9 and 18 months, 3, 6 and 9 years after Stannsoporfin administration
Investigators
Eligibility Criteria
Inclusion Criteria
- •All children who have been enrolled and received Stanate® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
NEUROLOGICAL EXAMINATION; Child Behavior Check List
Time Frame: 10 years
Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients