NCT00004381

Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 0 Years – 24 Hours
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Glucosephosphate Dehydrogenase Deficiency
• Hyperbilirubinemia
• Hemolytic Disease of Newborn

Interventions

Type	Name	Description
DRUG	tin mesoporphyrin

Timeline

• Start date: 1999-12-01
• First posted: 1999-10-19
• Last updated: 2005-06-24

Locations

2 sites across 1 country: United States