Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation

NCT00524394 | Terminated Results DMC

• 1 other identifier: HSC-MS-07-0021
• Study Type: observational
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and regulatory proteins (cytokines \& chemokines, in addition to antigen detection on antibody secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of infections in these high-risk patients.

Conditions

Premature Birth; Sepsis

Keywords

VLBW; sepsis; diagnosis; suspected sepsis

Outcome Measures

Primary Outcomes (2)

• Immunological Homeostasis

  Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages

  0 to 30 days of life.

• Cytokines

  IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .

  O TO 30 DAYS OF LIFE

Eligibility Criteria

• Age: Up to 3 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Premature infants

You may qualify if:

• Infants born at Children's Memorial Hermann Hospital with cord blood available \< 1500gm or \< 32 weeks gestation by OB estimate

You may not qualify if:

• Outborn infants transferred to CMHH without cord blood available
• Parents to not consent
• \> 1500gm or \> 32 weeks gestation by OB estimate

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Children's Memorial Hermann Hospital

Houston, Texas, 77030, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum only

MeSH Terms

Conditions

Premature Birth; Sepsis; Disease

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: James Murphy, PhD
• Organization: University of Texas Health Science Center

james.r.murphy@uth.tmc.edu

713-500-5714

Study Officials

• James R Murphy, PhD

  University of Texas at Houston

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2007
• First Posted: September 3, 2007
• Study Start: August 1, 2007
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2012
• Last Updated: December 14, 2015
• Results First Posted: December 14, 2015

Record last verified: 2015-11

Locations

US (1)