NCT00747591

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. Is urine S100B concentration correlated with the serum concentration of S100B in infants born at 29-36 weeks gestation. The presence and severity of intracranial pathology on S100B concentration will be investigated. Further analysis will demonstrate if birth weight, daily fluid intake, urine output, and urine creatinine influence this relationship.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2002

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2002

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2005

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2005

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 5, 2008

Completed
Last Updated

July 23, 2010

Status Verified

July 1, 2010

Enrollment Period

2.3 years

First QC Date

September 3, 2008

Last Update Submit

July 21, 2010

Conditions

Premature Infants

Keywords

urineconcentrationof S100B

Eligibility Criteria

AgeUp to 7 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

Preterm infants born at \<28 weeks gestation will be eligible for enrollment in this study.

You may qualify if:

  • Preterm 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, and clinically significant sepsis (retractable hypotension, neutropenia, and thrombocytopenia) will be excluded, other.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Utah

Salt Lake City, Utah, 84132, United States

Location

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Joanna Beachy, M.D.

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2008

First Posted

September 5, 2008

Study Start

November 1, 2002

Primary Completion

February 1, 2005

Study Completion

April 1, 2005

Last Updated

July 23, 2010

Record last verified: 2010-07

Locations

US(1)