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| ID | Type | Description | Link |
|---|---|---|---|
| RUH-0330795B |
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| Name | Class |
|---|---|
| Rockefeller University | OTHER |
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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| tin mesoporphyrin | Drug | |||
| Phototherapy | Procedure |
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.:
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| Name | Affiliation | Role |
|---|---|---|
| Attallah Kappas | Rockefeller University | Study Chair |
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| ID | Term |
|---|---|
| D006932 | Hyperbilirubinemia |
| D006402 | Hematologic Diseases |
| D035583 | Rare Diseases |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006425 | Hemic and Lymphatic Diseases |
| D020969 | Disease Attributes |
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| ID | Term |
|---|---|
| C055421 | tin mesoporphyrin |
| D010789 | Phototherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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