Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn

Interventions

tin mesoporphyrinDRUG

Eligibility

Sex: ALLMin age: 0 YearsMax age: 24 Hours

Medical Language ↔ Plain English

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

Locations (2)

New England Medical Center Hospital

Boston, Massachusetts, United States

Rockefeller University Hospital

New York, New York, United States

Data from ClinicalTrials.gov

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