Inflammatory Cytokines Associated With Perinatal Brain Injury

This study has been completed.
Sponsor:
Collaborators:
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT01035697
First received: December 17, 2009
Last updated: September 5, 2011
Last verified: August 2011

December 17, 2009
September 5, 2011
July 1999
July 2002   (final data collection date for primary outcome measure)
Pro-cytokines increased and anti-inflammatory cytokines decreased [ Time Frame: At birth and/or up to Day 3±1 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01035697 on ClinicalTrials.gov Archive Site
  • Type and severity of CP and other neurodevelopmental handicaps, the appearance of PVL, and neonatal mortality [ Time Frame: 18-22 months corrected age ] [ Designated as safety issue: No ]
  • Abnormal pro-inflammatory and anti-inflammatory cytokines at birth are associated with prenatal insults (e.g., chorioamnionitis, occult intrauterine infection, early-onset neonatal sepsis, perinatal asphyxia, early death) [ Time Frame: At birth ] [ Designated as safety issue: No ]
  • Abnormal postnatal cytokine levels associated with postnatal insults (e.g., postnatal intraventricular hemorrhage, late-onset neonatal sepsis, bronchopulmonary dysplasia, chronic lung disease, and/or necrotizing enterocolitis) [ Time Frame: Up to Day of life 21 ] [ Designated as safety issue: No ]
  • Pro-inflammatory cytokine elevations at the time of a workup for possible sepsis occur in infants with a positive bacterial blood culture and those with negative blood cultures who are treated with a full course of antibiotics [ Time Frame: Up to Day of life 21 ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Inflammatory Cytokines Associated With Perinatal Brain Injury
A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Whole blood spots collected on filter paper.

Probability Sample

Infants 401-1,000 grams at birth of both genders and all racial/ethnic groups.

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Cerebral Palsy
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1067
May 2004
July 2002   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Infants 401-1,000 grams at birth

Exclusion Criteria:

  • >72 hours of age
Both
up to 72 Hours
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01035697
NICHD-NRN-0022, U10HD027853, M01RR008084, U10HD040492, M01RR000030, U10HD027851, M01RR000039, U10HD027856, M01RR000750, U10HD021364, M01RR000080, U01HD036790, U10HD027880, M01RR000070, U10HD034216, M01RR000032, U10HD040461, U10HD021397, M01RR016587, U10HD027881, M01RR000997, U10HD021415, U10HD040689, M01RR000633, U10HD021373, U10HD040498, M01RR007122, U10HD021385, U10HD027904, U10HD027871, M01RR006022
No
Waldemar A. Carlo, MD, Lead Principal Investigator, University of Alabama at Birmingham
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Centers for Disease Control and Prevention
  • National Center for Research Resources (NCRR)
Principal Investigator: William Oh, MD Brown University, Women & Infants Hospital of Rhode Island
Principal Investigator: Michele C. Walsh, MD MS Case Western Reserve University, Rainbow Babies & Children's Hospital
Principal Investigator: Ronald N. Goldberg, MD Duke University
Principal Investigator: Barbara J. Stoll, MD Emory University
Principal Investigator: James A. Lemons, MD Indiana University
Principal Investigator: Abhik Das, PhD RTI International
Principal Investigator: David K. Stevenson, MD Stanford University
Principal Investigator: Waldemar A. Carlo, MD University of Alabama at Birmingham
Principal Investigator: Neil N. Finer, MD University of California, San Diego
Principal Investigator: Edward F. Donovan, MD Cincinnati Children's Medical Center
Principal Investigator: Shahnaz Duara, MD University of Miami
Principal Investigator: Lu-Ann Papile, MD University of New Mexico
Principal Investigator: Sheldon B. Korones, MD University of Tennessee
Principal Investigator: Jon E. Tyson, MD MPH The University of Texas Health Science Center, Houston
Principal Investigator: Abbot R. Laptook, MD University of Texas
Principal Investigator: T. Michael O'Shea, MD MPH Wake Forest School of Medicine
Principal Investigator: Seetha Shankaran, MD Wayne State University
Principal Investigator: Richard A. Ehrenkranz, MD Yale University
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP