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| ID | Type | Description | Link |
|---|---|---|---|
| RUH-0330795A |
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| Name | Class |
|---|---|
| Rockefeller University | OTHER |
OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece.
II. Assess the safety of tin mesoporphyrin in high-risk newborns.
PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum.
One group receives a preventive dose of tin mesoporphyrin. Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration.
Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tin mesoporphyrin | Drug |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics-- Hyperbilirubinemia associated with either of the following: Direct Coombs' test-positive ABO hemolytic disease of the newborn Glucose-6-phosphate dehydrogenase deficiency --Prior/Concurrent Therapy-- No maternal phenobarbital in last month of pregnancy --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No congenital renal abnormality Cardiovascular: No congenital heart abnormality Pulmonary: No asphyxia requiring assisted ventilation at delivery Other: Gestational age more than 210 days Birth weight at least 1500 g No other major congenital abnormality, i.e.: Central nervous system Chromosomal Gastrointestinal No evident or suspected congenital infection, e.g.: Cytomegalovirus Herpes Rubella Syphilis
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| Name | Affiliation | Role |
|---|---|---|
| Attallah Kappas | Rockefeller University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New England Medical Center Hospital | Boston | Massachusetts | 02111 | United States | ||
| Rockefeller University Hospital |
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| New York |
| New York |
| 10021-6399 |
| United States |
| ID | Term |
|---|---|
| D005955 | Glucosephosphate Dehydrogenase Deficiency |
| D006932 | Hyperbilirubinemia |
| D004899 | Erythroblastosis, Fetal |
| D006402 | Hematologic Diseases |
| D007232 | Infant, Newborn, Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
| D006425 | Hemic and Lymphatic Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D002239 | Carbohydrate Metabolism, Inborn Errors |
| D008661 | Metabolism, Inborn Errors |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005315 | Fetal Diseases |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D007154 | Immune System Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C055421 | tin mesoporphyrin |
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