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

Primary Purpose

Hyperbilirubinemia

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
tin mesoporphyrin
Phototherapy
Sponsored by
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hyperbilirubinemia focused on measuring hematologic disorders, hyperbilirubinemia, rare disease

Eligibility Criteria

undefined - 24 Hours (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 18, 1999
    Last Updated
    September 8, 2008
    Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Collaborators
    Rockefeller University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00004382
    Brief Title
    Phase II Study of Tin Mesoporphyrin vs Phototherapy for Hyperbilirubinemia in Premature Newborns
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    December 1999 (undefined)
    Primary Completion Date
    August 2007 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
    Collaborators
    Rockefeller University

    4. Oversight

    5. Study Description

    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.
    Detailed 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Hyperbilirubinemia
    Keywords
    hematologic disorders, hyperbilirubinemia, rare disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Allocation
    Randomized
    Enrollment
    80 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    tin mesoporphyrin
    Intervention Type
    Procedure
    Intervention Name(s)
    Phototherapy

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    24 Hours
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Attallah Kappas
    Organizational Affiliation
    Rockefeller University
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

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

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