Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns

This study has been completed.

First Received: October 18, 1999 Last Updated: September 8, 2008 History of Changes

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:	NCT00004382

Purpose

OBJECTIVES: I. Compare the effectiveness of a single dose of tin mesoporphyrin and special blue light phototherapy in controlling hyperbilirubinemia in premature newborns in Greece. II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.

Condition	Intervention	Phase
Hyperbilirubinemia	Drug: tin mesoporphyrin Procedure: Phototherapy	Phase II

MedlinePlus related topics: Jaundice

Drug Information available for: Tin mesoporphyrin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized

Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment:	80
Study Start Date:	December 1999
Primary Completion Date:	August 2007 (Final data collection date for primary outcome measure)

Detailed Description:

PROTOCOL OUTLINE: Patients are randomly assigned to a clinical group within 96 hours of birth. Patients are stratified by gestational age, clinical status, and age at treatment. One group receives tin mesoporphyrin. Patients are crossed to phototherapy if the plasma bilirubin concentration reaches the treatment threshold. The second group receives phototherapy with Special Blue fluorescent lamps for at least 24 hours. Patients receive a second phototherapy course if the plasma bilirubin concentration reaches the treatment threshold within 24 hours of the first course.

Eligibility

Ages Eligible for Study:	up to 24 Hours
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Premature infants of gestational age 210 to 251 days
No blood group isoimmunization (direct Coombs' positive), e.g., rhesus or ABO
No glucose-6-phosphate dehydrogenase deficiency

--Prior/Concurrent Therapy--

No maternal phenobarbital in last month of pregnancy

--Patient Characteristics--

Renal: No congenital renal abnormality

Cardiovascular: No congenital heart abnormality

Pulmonary: No asphyxia requiring assisted ventilation at delivery

Other: No other major congenital abnormality, i.e.:

Central nervous system
Chromosomal
Gastrointestinal

No evident or suspected congenital infection, i.e.:

Cytomegalovirus
Herpes
Rubella
Syphilis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00004382

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

Study ID Numbers:	199/12022, RUH-0330795B
Study First Received:	October 18, 1999
Last Updated:	September 8, 2008
ClinicalTrials.gov Identifier:	NCT00004382 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Office of Rare Diseases (ORD):

hematologic disorders
hyperbilirubinemia
rare disease

Study placed in the following topic categories:

Tin mesoporphyrin
Hematologic Diseases
Hyperbilirubinemia
Rare Diseases

Additional relevant MeSH terms:

Tin mesoporphyrin
Pathologic Processes
Molecular Mechanisms of Pharmacological Action

Hyperbilirubinemia
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 07, 2009