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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

This study has been completed.
Sponsor:
Collaborator:
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004381
First received: October 18, 1999
Last updated: June 23, 2005
Last verified: October 2003
History of Changes
  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 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

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
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rockefeller University
Investigators
Study Chair: Attallah Kappas Rockefeller University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004381     History of Changes
Other Study ID Numbers: 199/12021, RUH-0330795A
Study First Received: October 18, 1999
Last Updated: June 23, 2005
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

Additional relevant MeSH terms:
Erythroblastosis, Fetal
Glucosephosphate Dehydrogenase Deficiency
Hyperbilirubinemia
Hemolysis
Hyperbilirubinemia, Neonatal
Fetal Diseases
Pregnancy Complications
Blood Group Incompatibility
Hematologic Diseases
Infant, Newborn, Diseases
Immune System Diseases
Anemia, Hemolytic, Congenital
 Anemia, Hemolytic
Anemia
Genetic Diseases, Inborn
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Pathologic Processes
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013