Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
NCT ID: NCT00004382
Last Updated: 2008-09-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
80 participants
INTERVENTIONAL
1999-12-31
Brief Summary
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II. Evaluate the dose of tin mesoporphyrin sufficient to alleviate the need for phototherapy without adverse effects in these newborns.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
Interventions
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tin mesoporphyrin
Phototherapy
Eligibility Criteria
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Inclusion 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
24 Hours
ALL
No
Sponsors
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Rockefeller University
OTHER
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
Principal Investigators
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Attallah Kappas
Role: STUDY_CHAIR
Rockefeller University
Other Identifiers
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RUH-0330795B
Identifier Type: -
Identifier Source: secondary_id
199/12022
Identifier Type: -
Identifier Source: org_study_id
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