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.

Condition	Treatment or Intervention	Phase
Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn	Drug: tin mesoporphyrin	Phase II

Further Study 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.

Ages Eligible for Study:  up to  24 Hours,  Genders Eligible for Study:  Both

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

Massachusetts
      New England Medical Center Hospital, Boston,  Massachusetts,  02111,  United States
New York
      Rockefeller University Hospital, New York,  New York,  10021-6399,  United States

Study chairs or principal investigators

Attallah Kappas,  Study Chair,  Rockefeller University   

Study ID Numbers:  199/12021; RUH-0330795A
Record last reviewed:  October 2003
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004381
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08