Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia (NCT00004381) | Clinical Trial Compass
CompletedPhase 2
Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia
United StatesStarted 1999-12
Plain-language summary
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.
Who can participate
Age range0 Years – 24 Hours
SexALL
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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
Trial details
NCT IDNCT00004381
SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)