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

This study has been completed.
Sponsor:
Collaborator:
Rockefeller University
Information provided by:
Office of Rare Diseases (ORD)
ClinicalTrials.gov Identifier:
NCT00004382
First received: October 18, 1999
Last updated: September 8, 2008
Last verified: September 2008
  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

Ages Eligible for Study:   up to 24 Hours
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004382

Sponsors and Collaborators
Rockefeller University
Investigators
Study Chair: Attallah Kappas Rockefeller University
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00004382     History of Changes
Other Study ID Numbers: 199/12022, RUH-0330795B
Study First Received: October 18, 1999
Last Updated: September 8, 2008
Health Authority: United States: Federal Government

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
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 23, 2014