Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
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ClinicalTrials.gov Identifier: NCT00004381 |
Recruitment Status
:
Completed
First Posted
: October 19, 1999
Last Update Posted
: June 24, 2005
|
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn | Drug: tin mesoporphyrin | Phase 2 |
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.
Study Type : | Interventional (Clinical Trial) |
Primary Purpose: | Treatment |
Study Start Date : | December 1999 |


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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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
ClinicalTrials.gov Identifier: | NCT00004381 History of Changes |
Other Study ID Numbers: |
199/12021 RUH-0330795A |
First Posted: | October 19, 1999 Key Record Dates |
Last Update Posted: | June 24, 2005 |
Last Verified: | October 2003 |
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 |