Completed

Tin Mesoporphyrin for Neonatal Hyperbilirubinemia Management

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What is being tested

tin mesoporphyrin

Drug
Who is being recruted

Urogenital Diseases+21

+ Anemia

+ Anemia, Hemolytic

See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: December 1999
See protocol details

Summary

Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Study start date: December 1, 1999

Actual date on which the first participant was enrolled.

PROTOCOL OUTLINE: Patients are stratified by gestational age and sex, and randomly assigned in pairs per stratum. One group receives a preventive dose of tin mesoporphyrin. Another group receives a therapeutic dose of tin mesoporphyrin according to the plasma bilirubin concentration. Patients in either group may be treated concurrently with phototherapy or exchange transfusion if clinically indicated.

NCT00004381
Principal SponsorEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Last updated: June 24, 2005
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesAnemiaAnemia, HemolyticAnemia, Hemolytic, CongenitalCarbohydrate Metabolism, Inborn ErrorsFemale Urogenital Diseases and Pregnancy ComplicationsFetal DiseasesHemic and Lymphatic DiseasesImmune System DiseasesMetabolic DiseasesMetabolism, Inborn ErrorsCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesNutritional and Metabolic DiseasesPathologic ProcessesPregnancy ComplicationsPathological Conditions, Signs and SymptomsDisease AttributesGenetic Diseases, InbornErythroblastosis, FetalGlucosephosphate Dehydrogenase DeficiencyHematologic DiseasesHyperbilirubinemiaInfant, Newborn, DiseasesRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Hyperbilirubinemia associated with either of the following: Direct Coombs' test-positive ABO hemolytic disease of the newborn Glucose-6-phosphate dehydrogenase deficiency --Prior/Concurrent Therapy-- No maternal phenobarbital in last month of pregnancy --Patient Characteristics-- Performance status: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: No congenital renal abnormality Cardiovascular: No congenital heart abnormality Pulmonary: No asphyxia requiring assisted ventilation at delivery Other: Gestational age more than 210 days Birth weight at least 1500 g No other major congenital abnormality, i.e.: Central nervous system Chromosomal Gastrointestinal No evident or suspected congenital infection, e.g.: Cytomegalovirus Herpes Rubella Syphilis

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

New England Medical Center Hospital

Boston, United StatesOpen New England Medical Center Hospital in Google Maps

Rockefeller University Hospital

New York, United States
Completed2 Study Centers