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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Rockefeller University |
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Information provided by: | Office of Rare Diseases (ORD) |
ClinicalTrials.gov Identifier: | NCT00004382 |
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 |
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Hyperbilirubinemia |
Drug: tin mesoporphyrin Procedure: Phototherapy |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized |
Estimated Enrollment: | 80 |
Study Start Date: | December 1999 |
Primary Completion Date: | August 2007 (Final data collection date for primary outcome measure) |
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.
Ages Eligible for Study: | up to 24 Hours |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--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.:
No evident or suspected congenital infection, i.e.:
Study ID Numbers: | 199/12022, RUH-0330795B |
Study First Received: | October 18, 1999 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00004382 |
Health Authority: | United States: Federal Government |
hematologic disorders hyperbilirubinemia rare disease |
Tin mesoporphyrin Hematologic Diseases Hyperbilirubinemia Rare Diseases |
Pathologic Processes Molecular Mechanisms of Pharmacological Action Enzyme Inhibitors Pharmacologic Actions |