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NCT00004381 Clinical Trial

Phase II Randomized Study of Tin Mesoporphyrin for Neonatal Hyperbilirubinemia

Hyperbilirubinemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004381
Other study ID # 199/12021
Secondary ID RUH-0330795A
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated June 23, 2005
Start date December 1999

Study information
Verified date October 2003
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Hours
Eligibility 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

Study Design

Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tin mesoporphyrin

Locations
Country Name City State
United States New England Medical Center Hospital Boston Massachusetts
United States Rockefeller University Hospital New York New York

Sponsors (2)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Rockefeller University

Country where clinical trial is conducted

United States, 

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