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

NCT00004382 | Completed Phase 2

• 2 other identifiers: 199/12022RUH-0330795B
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Hyperbilirubinemia

Keywords

hematologic disorders; hyperbilirubinemia; rare disease

Interventions

tin mesoporphyrin DRUG

Phototherapy PROCEDURE

Eligibility Criteria

• Age: Up to 24 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Rockefeller University: collaborator

MeSH Terms

Conditions

Hyperbilirubinemia; Hematologic Diseases; Rare Diseases

Interventions

tin mesoporphyrin; Phototherapy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hemic and Lymphatic Diseases; Disease Attributes

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Attallah Kappas

  Rockefeller University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 18, 1999
• First Posted: October 19, 1999
• Study Start: December 1, 1999
• Primary Completion: August 1, 2007
• Last Updated: September 9, 2008

Record last verified: 2008-09