NCT00004381

Brief Summary

OBJECTIVES: I. Compare the efficacy of preventive vs. therapeutic tin mesoporphyrin in direct Coombs' test-positive ABO hemolytic disease of the newborn and glucose-6-phosphate dehydrogenase deficiency in infants living in Greece. II. Assess the safety of tin mesoporphyrin in high-risk newborns.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 1999

Completed
Last Updated

June 24, 2005

Status Verified

October 1, 2003

First QC Date

October 18, 1999

Last Update Submit

June 23, 2005

Conditions

Glucosephosphate Dehydrogenase DeficiencyHyperbilirubinemiaHemolytic Disease of Newborn

Keywords

glucose-6-phosphate dehydrogenase deficiencyhematologic disordershemolytic diseasehyperbilirubinemianeonatal disordersrare disease

Interventions

tin mesoporphyrinDRUG

Eligibility Criteria

Age0 Years - 24 Hours
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
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

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

Sponsors & Collaborators

Study Sites (2)

New England Medical Center Hospital

Boston, Massachusetts, 02111, United States

Location

Rockefeller University Hospital

New York, New York, 10021-6399, United States

Location

MeSH Terms

Conditions

Glucosephosphate Dehydrogenase DeficiencyHyperbilirubinemiaErythroblastosis, FetalHematologic DiseasesInfant, Newborn, DiseasesRare Diseases

Interventions

tin mesoporphyrin

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, CongenitalAnemia, HemolyticAnemiaHemic and Lymphatic DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCarbohydrate Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsMetabolic DiseasesNutritional and Metabolic DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsFetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesImmune System DiseasesDisease Attributes

Study Officials

  • Attallah Kappas

    Rockefeller University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

December 1, 1999

Last Updated

June 24, 2005

Record last verified: 2003-10

Locations

US(2)