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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia



Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

For Condition: Hemolytic Disease of Newborn,Hyperbilirubinemia,Glucosephosphate Dehydrogenase Deficiency
Status: Completed
Sponsor(s): National Institute of Child Health and Human Development (NICHD) , Rockefeller University
Synopsis: 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.
Details: 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.
Eligibility:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: /24 Hours
Genders: Both
Protocol Entry Criteria: 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
AttallahKappas,  Study Chair,  Rockefeller University

New England Medical Center Hospital
Boston,  Massachusetts,  02111
United States
 

Rockefeller University Hospital
New York City,  New York,  10021-6399
United States
 


Additional Information:
Study ID Numbers:
  199/12021;  RUH-0330795A
Study Start Date: December 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004381

Other Hemolytic Disease Of Newborn Studies:
1. Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

2. A Test to Predict the Hemolytic Potential of Drugs in G6PD Deficiency

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