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:

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

MedlinePlus related topics: G6PD Deficiency Jaundice

Genetic and Rare Diseases Information Center resources: Glucose-6-phosphate Dehydrogenase Deficiency

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 (Child)
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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


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:


Pregnancy Complications Hemolysis Hyperbilirubinemia Hyperbilirubinemia, Neonatal Glucosephosphate Dehydrogenase Deficiency Erythroblastosis, Fetal Pathologic Processes Infant, Newborn, Diseases Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia	Hematologic Diseases Genetic Diseases, Inborn Carbohydrate Metabolism, Inborn Errors Metabolism, Inborn Errors Metabolic Diseases Fetal Diseases Immune System Diseases Tin mesoporphyrin Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2016

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