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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
• Collaborator: Rockefeller University
• Treatments: Tin mesoporphyrin

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