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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
  Purpose

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.


Condition
Infant, Newborn
Infant, Low Birth Weight
Infant, Small for Gestational Age
Infant, Premature
Cerebral Palsy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death

Resource links provided by NLM:


Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Primary Outcome Measures:
  • Pro-cytokines increased and anti-inflammatory cytokines decreased [ Time Frame: At birth and/or up to Day 3±1 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA

Whole blood spots collected on filter paper.


Enrollment: 1067
Study Start Date: July 1999
Study Completion Date: May 2004
Primary Completion Date: July 2002 (Final data collection date for primary outcome measure)
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

Ages Eligible for Study:   up to 72 Hours
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

  • Infants 401-1,000 grams at birth

Exclusion Criteria:

  • >72 hours of age
  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: NCT01035697

Locations
United States, Alabama
University of Alabama
Birmingham, Alabama, United States, 35249-7335
United States, California
Stanford University
Palo Alto, California, United States, 94304
University of California at San Diego
San Diego, California, United States, 92103-8774
United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06504
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30303
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48201
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
United States, North Carolina
Wake Forest University
Charlotte, North Carolina, United States, 27157
Duke University
Durham, North Carolina, United States, 27710
RTI International
Durham, North Carolina, United States, 27705
United States, Ohio
Cincinnati Children's Medical Center
Cincinnati, Ohio, United States, 45267
Case Western Reserve University, Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Rhode Island
Brown University, Women & Infants Hospital of Rhode Island
Providence, Rhode Island, United States, 02905
United States, Tennessee
University of Tennessee
Memphis, Tennessee, United States, 38163
United States, Texas
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75235
University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Sponsors and Collaborators
Investigators
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
  More Information

Additional Information:
Publications:
Responsible Party: Waldemar A. Carlo, MD, Lead Principal Investigator, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01035697     History of Changes
Other Study ID Numbers: 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
Study First Received: December 17, 2009
Last Updated: September 5, 2011
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
NICHD Neonatal Research Network
Very Low Birth Weight (VLBW)
Extremely Low Birth Weight (ELBW)
Prematurity
Pro-inflammatory cytokines
Anti-inflammatory cytokines
Interleukin-1 (IL-1β)
Interleukin-2 (IL-2)
Interleukin-3 (IL-3)
Interleukin-8 (IL-8)
Interleukin-9 (IL-9)
Tumor necrosis factor-α (TNF-α)
Regulated upon Activation, Normal T-cell Expressed and Secreted (RANTES)

Additional relevant MeSH terms:
Birth Weight
Brain Injuries
Cerebral Palsy
Body Weight
Brain Damage, Chronic
Brain Diseases
Central Nervous System Diseases
Craniocerebral Trauma
Nervous System Diseases
Signs and Symptoms
Trauma, Nervous System
Wounds and Injuries

ClinicalTrials.gov processed this record on November 20, 2014