Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation (AOS)

This study has been terminated.
(recruitment not possible)
Sponsor:
Information provided by (Responsible Party):
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00524394
First received: August 30, 2007
Last updated: November 5, 2015
Last verified: November 2015
  Purpose
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.

Condition
Premature Birth
Sepsis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Characteristics of Cord Blood Immunologic Parameters of Infants < 32 Weeks Gestation

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • Immunological Homeostasis [ Time Frame: 0 to 30 days of life. ] [ Designated as safety issue: No ]
    Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages

  • Cytokines [ Time Frame: O TO 30 DAYS OF LIFE ] [ Designated as safety issue: No ]
    IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .


Biospecimen Retention:   Samples Without DNA
Serum only

Enrollment: 2
Study Start Date: August 2007
Study Completion Date: January 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   up to 3 Days   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Premature infants
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Outborn infants transferred to CMHH without cord blood available
  • Parents to not consent
  • > 1500gm or > 32 weeks gestation by OB estimate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00524394

Locations
United States, Texas
Children's Memorial Hermann Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
Principal Investigator: James R Murphy, PhD University of Texas at Houston
  More Information

Responsible Party: The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier: NCT00524394     History of Changes
Other Study ID Numbers: HSC-MS-07-0021 
Study First Received: August 30, 2007
Results First Received: July 17, 2013
Last Updated: November 5, 2015
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas Health Science Center, Houston:
VLBW
sepsis
diagnosis
suspected sepsis

Additional relevant MeSH terms:
Sepsis
Premature Birth
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on July 25, 2016