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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004381
First Posted: October 19, 1999
Last Update Posted: December 9, 2005
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
October 18, 1999
October 19, 1999
December 9, 2005
December 1999
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No Changes Posted
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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
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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.

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.

Interventional
Phase 2
Primary Purpose: Treatment
  • Glucosephosphate Dehydrogenase Deficiency
  • Hyperbilirubinemia
  • Hemolytic Disease of Newborn
Drug: tin mesoporphyrin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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

Sexes Eligible for Study: All
up to 24 Hours   (Child)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004381
199/12021
RUH-0330795A
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rockefeller University
Study Chair: Attallah Kappas Rockefeller University
Office of Rare Diseases (ORD)
October 2003

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP