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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn | Drug: tin mesoporphyrin | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Primary Purpose: Treatment |
| Study Start Date: | December 1999 |
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.
Eligibility| Ages Eligible for Study: | up to 24 Hours (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00004381
| United States, Massachusetts | |
| New England Medical Center Hospital | |
| Boston, Massachusetts, United States, 02111 | |
| United States, New York | |
| Rockefeller University Hospital | |
| New York, New York, United States, 10021-6399 | |
| Study Chair: | Attallah Kappas | Rockefeller University |
More Information
| ClinicalTrials.gov Identifier: | NCT00004381 History of Changes |
| Other Study ID Numbers: |
199/12021 RUH-0330795A |
| Study First Received: | October 18, 1999 |
| Last Updated: | June 23, 2005 |
Keywords provided by Office of Rare Diseases (ORD):
|
glucose-6-phosphate dehydrogenase deficiency hematologic disorders hemolytic disease |
hyperbilirubinemia neonatal disorders rare disease |
Additional relevant MeSH terms:
|
Hemolysis Hyperbilirubinemia Erythroblastosis, Fetal Glucosephosphate Dehydrogenase Deficiency Pathologic Processes Fetal Diseases Pregnancy Complications Hematologic Diseases Infant, Newborn, Diseases Immune System Diseases |
Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia Genetic Diseases, Inborn Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Tin mesoporphyrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |
ClinicalTrials.gov processed this record on August 22, 2017