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

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hyperbilirubinemia

Keywords

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hematologic disorders hyperbilirubinemia rare disease

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Interventions

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tin mesoporphyrin

Intervention Type DRUG

Phototherapy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion 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

Maximum Eligible Age

24 Hours

Eligible Sex

ALL

Accepts Healthy Volunteers

No

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