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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004382

Enrollment

Registered

1999-10-19

Start date

1999-12-31

Completion date

Unknown

Last updated

2008-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperbilirubinemia

Keywords

hematologic disorders, hyperbilirubinemia, rare disease

Brief 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.

Detailed description

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.

Interventions

DRUGtin mesoporphyrin

PROCEDUREPhototherapy

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

No minimum to 24 Hours

Healthy volunteers

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026