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.
We do not endorse or review these studies in any way.
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.
Keywords
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
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
