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Relationship of Gestational Age and Urine Concentration of S100B in Preterm and Term Infants in the First Week of Life

This study has been completed.
Sponsor:
Information provided by:
University of Utah
ClinicalTrials.gov Identifier:
NCT00747864
First received: September 3, 2008
Last updated: July 21, 2010
Last verified: July 2010
History of Changes
  Purpose

S100B, a calcium-binding protein, is found predominantly in the central nervous system (CNS) and is increased in CSF and blood after CNS injury. There are two objectives to this study. 1) To complement our previous study, is urine S100B concentration correlated with gestational age in infants born at > 28 weeks gestation during the first week of life? 2) Is the urine concentration of S100B affected by intracranial pathology in this gestational age range? Elevation of urine concentration of S100B may be an indicator that the infant will develop serious intracranial pathology and may allow for early initiation of treatment to potentially decrease morbidity.


Condition
Preterm and Term Infants

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Relationship of Gestational Age and Urine Concentration of S100B in Preterm and Term Infants in the First Week of Life

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Utah:

Enrollment: 106
Study Start Date: April 2006
Study Completion Date: January 2007
Primary Completion Date: December 2006 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 48 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Infants born at >28 weeks gestation will be eligible for enrollment in this study. Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded. Infants that meet criteria will be enrolled in this study if the parent(s) sign the consent form. There are no patient safety or adverse event issues as this study is non-invasive and observational only.

Criteria

Inclusion Criteria:

  • Infants born at >28 weeks gestation will be eligible for enrollment in this study.

Exclusion Criteria:

  • Infants with fetal malformations, chromosomal anomalies, clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia), or no urine output for the first 48 hours will be excluded.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00747864

Sponsors and Collaborators
University of Utah
Investigators
Principal Investigator: Joanna Beachy, M.D. University of Utah
  More Information

No publications provided

Responsible Party: Joanna Beachy Ph.D., M.D., University of Utah
ClinicalTrials.gov Identifier: NCT00747864     History of Changes
Other Study ID Numbers: 14083
Study First Received: September 3, 2008
Last Updated: July 21, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Utah:
Gestational Age
Urine
Concentration
of S100B

ClinicalTrials.gov processed this record on May 19, 2013