Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

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.

Completed

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Key information

Conditions

Glucosephosphate Dehydrogenase Deficiency Anemia Anemia, Hemolytic Anemia, Hemolytic, Congenital Carbohydrate Metabolism, Inborn Errors Congenital, Hereditary, and Neonatal Diseases and Abnormalities Disease Attributes Erythroblastosis, Fetal Female Urogenital Diseases and Pregnancy Complications Fetal Diseases Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemolytic Disease of Newborn Hyperbilirubinemia Immune System Diseases Infant, Newborn, Diseases Metabolic Diseases Metabolism, Inborn Errors Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Rare Diseases Urogenital Diseases

Age range

0 year–24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New England Medical Center Hospital, Boston, Massachusetts, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tin mesoporphyrin

Drug

Sponsors and collaborators

Lead sponsor

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

Nih

Collaborators

Rockefeller University

Registry information

Important dates

Study start: 1999
First posted: Oct 19, 1999
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed