Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
NCT00004382 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80
Last updated 2008-09-09
Summary
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.
Conditions
- Hyperbilirubinemia
Interventions
- DRUG
-
tin mesoporphyrin
- PROCEDURE
-
Phototherapy
Sponsors & Collaborators
-
Rockefeller University
collaborator OTHER -
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
lead NIH
Principal Investigators
-
Attallah Kappas · Rockefeller University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
Eligibility
- Max Age
- 24 Hours
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 1999-12-31
- Primary Completion
- 2007-08-31
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