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

NCT00747864 | Completed

• 1 other identifier: 14083
• Study Type: observational
• Target: 106
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Preterm and Term Infants

Keywords

Gestational Age; Urine; Concentration; of S100B

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Utah: lead

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Joanna Beachy, M.D.

  University of Utah

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 3, 2008
• First Posted: September 5, 2008
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: January 1, 2007
• Last Updated: July 23, 2010

Record last verified: 2010-07