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

This study is ongoing, but not recruiting participants.

Sponsored by:	University of Utah
Information provided by:	University of Utah
ClinicalTrials.gov Identifier:	NCT00747864

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

MedlinePlus related topics: Urine and Urination

U.S. FDA Resources

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

Further study details as provided by University of Utah:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	150
Study Start Date:	April 2006
Estimated Study Completion Date:	April 2009
Estimated Primary Completion Date:	April 2009 (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

Responsible Party:	University of Utah ( Joanna Beachy Ph.D., M.D. )
Study ID Numbers:	14083
Study First Received:	September 3, 2008
Last Updated:	September 4, 2008
ClinicalTrials.gov Identifier:	NCT00747864
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 January 14, 2009