Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia - Full Text View

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

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Rockefeller University

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