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Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

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ClinicalTrials.gov Identifier: NCT00004381
Recruitment Status : Completed
First Posted : October 19, 1999
Last Update Posted : June 24, 2005
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment Phase
Glucosephosphate Dehydrogenase Deficiency Hyperbilirubinemia Hemolytic Disease of Newborn Drug: tin mesoporphyrin Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Study Start Date : December 1999


Arms and Interventions


Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00004381     History of Changes
Other Study ID Numbers: 199/12021
RUH-0330795A
First Posted: October 19, 1999    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: October 2003

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:
Hemolysis
Hyperbilirubinemia
Erythroblastosis, Fetal
Glucosephosphate Dehydrogenase Deficiency
Pathologic Processes
Fetal Diseases
Pregnancy Complications
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
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action