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Study stopped for business reasons and not for any safety reasons.
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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 StanateĀ® In Infants At-Risk For Exchange Transfusion".
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 StanateĀ® 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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.75 mg/kg Previous exposure to stannsoporfin | Previous exposure 0.75 mg/kg |
| |
| 1.5 mg/kg Previous exposure to stannsoporfin | Previous exposure 1.5 mg/kg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Previous exposure to stannsoporfin | Other | No intervention in this protocol |
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| Measure | Description | Time Frame |
|---|---|---|
| NEUROLOGICAL EXAMINATION; Child Behavior Check List | Child Behavior Check List is a standardized measure in child psychology for evaluating maladaptive behavioral and emotional problems in preschool patients | 10 years |
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Inclusion Criteria:
Exclusion Criteria:
-
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All children who have been enrolled and received StanateĀ® Injection/Placebo in Study Protocol 64,185-06-2(W)(WS)(ISNHP) are eligible for this follow-up.
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| Name | Affiliation | Role |
|---|---|---|
| Nancy Ruiz, MD | InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company | Study Director |
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| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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