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Spots Global Cancer Trial Database for Inflammatory Cytokines Associated With Perinatal Brain Injury

The following info and data is provided "as is" to help patients around the globe.
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Trial Identification

Brief Title: Inflammatory Cytokines Associated With Perinatal Brain Injury

Official Title: A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

Study ID: NCT01035697

Interventions

Study Description

Brief Summary: This observational study assessed whether measurements of certain pro-inflammatory and anti-inflammatory cytokines in the blood (either singly or in combination) at birth and/or up to day of life 21 can predict cerebral palsy at 18-22 months corrected age.

Detailed Description: Inflammatory cytokines \[interleukin-1 (IL-1β), IL-8, IL-9, tumor necrosis factor-α (TNF-α), and RANTES\] but not anti-inflammatory cytokines released during the perinatal period have been associated with the development of periventricular leukomalacia (PVL) and cerebral palsy (CP) in near term and term infants. However, because blood samples were obtained on any day between day 1 and 18, these data cannot distinguish between prenatal and postnatal effects on neurological outcome. Furthermore, very low birth weight infants who are at the highest risk have not been studies. The goal of this study was to measure pro-inflammatory and anti-inflammatory cytokine levels at various times in the perinatal period (at birth up to day of life 21), since they may be elevated at different points in the disease process. Blood samples (whole blood spots, dried on filter paper) were obtained on day 1 within 4 hours after birth, and on days 3, 7, 14, and 21. Neurodevelopmental assessments were conducted at 18-22 months corrected age.

Eligibility

Minimum Age:

Eligible Ages: CHILD

Sex: ALL

Healthy Volunteers: Yes

Locations

University of Alabama, Birmingham, Alabama, United States

Stanford University, Palo Alto, California, United States

University of California at San Diego, San Diego, California, United States

Yale University, New Haven, Connecticut, United States

University of Miami, Miami, Florida, United States

Emory University, Atlanta, Georgia, United States

Indiana University, Indianapolis, Indiana, United States

Wayne State University, Detroit, Michigan, United States

University of New Mexico, Albuquerque, New Mexico, United States

Wake Forest University, Charlotte, North Carolina, United States

RTI International, Durham, North Carolina, United States

Duke University, Durham, North Carolina, United States

Cincinnati Children's Medical Center, Cincinnati, Ohio, United States

Case Western Reserve University, Rainbow Babies and Children's Hospital, Cleveland, Ohio, United States

Brown University, Women & Infants Hospital of Rhode Island, Providence, Rhode Island, United States

University of Tennessee, Memphis, Tennessee, United States

University of Texas Southwestern Medical Center at Dallas, Dallas, Texas, United States

University of Texas Health Science Center at Houston, Houston, Texas, United States

Contact Details

Name: William Oh, MD

Affiliation: Brown University, Women & Infants Hospital of Rhode Island

Role: PRINCIPAL_INVESTIGATOR

Name: Michele C. Walsh, MD MS

Affiliation: Case Western Reserve University, Rainbow Babies & Children's Hospital

Role: PRINCIPAL_INVESTIGATOR

Name: Ronald N. Goldberg, MD

Affiliation: Duke University

Role: PRINCIPAL_INVESTIGATOR

Name: Barbara J. Stoll, MD

Affiliation: Emory University

Role: PRINCIPAL_INVESTIGATOR

Name: James A. Lemons, MD

Affiliation: Indiana University

Role: PRINCIPAL_INVESTIGATOR

Name: Abhik Das, PhD

Affiliation: RTI International

Role: PRINCIPAL_INVESTIGATOR

Name: David K. Stevenson, MD

Affiliation: Stanford University

Role: PRINCIPAL_INVESTIGATOR

Name: Waldemar A. Carlo, MD

Affiliation: University of Alabama at Birmingham

Role: PRINCIPAL_INVESTIGATOR

Name: Neil N. Finer, MD

Affiliation: University of California, San Diego

Role: PRINCIPAL_INVESTIGATOR

Name: Edward F. Donovan, MD

Affiliation: Children's Hospital Medical Center, Cincinnati

Role: PRINCIPAL_INVESTIGATOR

Name: Shahnaz Duara, MD

Affiliation: University of Miami

Role: PRINCIPAL_INVESTIGATOR

Name: Lu-Ann Papile, MD

Affiliation: University of New Mexico

Role: PRINCIPAL_INVESTIGATOR

Name: Sheldon B. Korones, MD

Affiliation: University of Tennessee

Role: PRINCIPAL_INVESTIGATOR

Name: Jon E. Tyson, MD MPH

Affiliation: The University of Texas Health Science Center, Houston

Role: PRINCIPAL_INVESTIGATOR

Name: Abbot R. Laptook, MD

Affiliation: University of Texas

Role: PRINCIPAL_INVESTIGATOR

Name: T. Michael O'Shea, MD MPH

Affiliation: Wake Forest University

Role: PRINCIPAL_INVESTIGATOR

Name: Seetha Shankaran, MD

Affiliation: Wayne State University

Role: PRINCIPAL_INVESTIGATOR

Name: Richard A. Ehrenkranz, MD

Affiliation: Yale University

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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