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

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.

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Key information

Conditions

Hyperbilirubinemia Disease Attributes Hematologic Diseases Hemic and Lymphatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases

Age range

Up to 24 hour

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tin mesoporphyrin

Drug

Phototherapy

Procedure

Sponsors and collaborators

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Nih

Collaborators

Rockefeller University

Registry information

Important dates

Study start: 1999
Primary completion: 2007
First posted: Oct 19, 1999
Registry last updated: Sep 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed