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NCT00004382 Clinical Trial

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

Hyperbilirubinemia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004382
Other study ID # 199/12022
Secondary ID RUH-0330795B
Status Completed
Phase Phase 2
First received October 18, 1999
Last updated September 8, 2008
Start date December 1999

Study information
Verified date September 2008
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 24 Hours
Eligibility 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

Study Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• tin mesoporphyrin

Procedure:
• Phototherapy

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Rockefeller University
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