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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

This study has been completed.

Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rockefeller University
Information provided by: Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier: NCT00004381
  Purpose

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

Genetics Home Reference related topics:   glucose-6-phosphate dehydrogenase deficiency   

MedlinePlus related topics:   Jaundice   

Drug Information available for:   Dextrose    Tin mesoporphyrin   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment

Further study details as provided by Office of Rare Diseases (ORD):

Study Start Date:   December 1999

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.

  Eligibility
Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004381

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

Sponsors and Collaborators

Investigators
Study Chair:     Attallah Kappas     Rockefeller University    
  More Information


Study ID Numbers:   199/12021, RUH-0330795A
First Received:   October 18, 1999
Last Updated:   June 23, 2005
ClinicalTrials.gov Identifier:   NCT00004381
Health Authority:   United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):
glucose-6-phosphate dehydrogenase deficiency  
hematologic disorders  
hemolytic disease  
hyperbilirubinemia
neonatal disorders
rare disease

Study placed in the following topic categories:
Glucose 6 phosphate dehydrogenase deficiency
Erythroblastosis, Fetal
Metabolic Diseases
Pregnancy Complications
Von Gierke disease
Hematologic Diseases
Rare Diseases
Anemia
Glucosephosphate Dehydrogenase Deficiency
Anemia, Hemolytic
Glycogen Storage Disease Type I
Hyperbilirubinemia, Neonatal
Metabolism, Inborn Errors
Anemia, Hemolytic, Congenital
Fetal Diseases
Tin mesoporphyrin
Genetic Diseases, Inborn
Hyperbilirubinemia
Infant, Newborn, Diseases
Metabolic disorder

Additional relevant MeSH terms:
Pathologic Processes
Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Enzyme Inhibitors
Blood Group Incompatibility
Carbohydrate Metabolism, Inborn Errors
Pharmacologic Actions

ClinicalTrials.gov processed this record on November 30, 2008




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