Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Brief Summary
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1. the infant has a very high level of bilirubin without an adequate clinical response to phototherapy;
2. the infant requires an exchange transfusion; and
3. the family refuses to allow the administration of blood products, particularly on religious grounds, such as within the Jehovah's Witness community.
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Detailed Description
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Conditions
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Interventions
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Stanate (TM) [stannsoporfin, tin-mesoporphyrin]
Treatment with 4.5 mg/kg
Eligibility Criteria
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Inclusion Criteria
* Elevated serum bilirubin
* Failing phototherapy
* Requires exchange transfusion
* Family refuses exchange transfusion on religious grounds
12 Hours
1 Week
ALL
No
Sponsors
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InfaCare Pharmaceuticals Corporation, a Mallinckrodt Company
INDUSTRY
Responsible Party
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Locations
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William Beaumont Hospital
Royal Oak, Michigan, United States
Countries
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References
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Kappas A, Drummond GS, Munson DP, Marshall JR. Sn-Mesoporphyrin interdiction of severe hyperbilirubinemia in Jehovah's Witness newborns as an alternative to exchange transfusion. Pediatrics. 2001 Dec;108(6):1374-7. doi: 10.1542/peds.108.6.1374.
Other Identifiers
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99A
Identifier Type: -
Identifier Source: org_study_id
NCT01183988
Identifier Type: -
Identifier Source: nct_alias
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