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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004382
First Posted: October 19, 1999
Last Update Posted: September 9, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
  Purpose

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.


Condition Intervention Phase
Hyperbilirubinemia Drug: tin mesoporphyrin Procedure: Phototherapy Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Office of Rare Diseases (ORD):

Estimated Enrollment: 80
Study Start Date: December 1999
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

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Ages Eligible for Study:   up to 24 Hours   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004382


Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Rockefeller University
Investigators
Study Chair: Attallah Kappas Rockefeller University
  More Information

ClinicalTrials.gov Identifier: NCT00004382     History of Changes
Other Study ID Numbers: 199/12022
RUH-0330795B
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: September 9, 2008
Last Verified: September 2008

Keywords provided by Office of Rare Diseases (ORD):
hematologic disorders
hyperbilirubinemia
rare disease

Additional relevant MeSH terms:
Hyperbilirubinemia
Pathologic Processes
Tin mesoporphyrin
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action