Long-Term Clinical Follow-Up of Children Enrolled in Stannsoporfin Clinical Trial Protocol No. 64,185-06-2(W)

InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company55 enrolled

Overview

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".

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hyperbilirubinemia

Interventions

Previous exposure to stannsoporfinOTHER

No intervention in this protocol

Eligibility

Sex: ALLMin age: 1 DayMax age: 60 Days

Medical Language ↔ Plain English

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: \-

Outcomes

Primary Outcomes

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

Time frame: 10 years

Data from ClinicalTrials.gov

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