- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01035697
Inflammatory Cytokines Associated With Perinatal Brain Injury (Cytokines)
A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35249-7335
- University of Alabama
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California
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Palo Alto, California, United States, 94304
- Stanford University
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San Diego, California, United States, 92103-8774
- University of California at San Diego
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Connecticut
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New Haven, Connecticut, United States, 06504
- Yale University
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Florida
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Miami, Florida, United States, 33136
- University of Miami
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Georgia
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Atlanta, Georgia, United States, 30303
- Emory University
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Indiana
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Indianapolis, Indiana, United States, 46202
- Indiana University
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Michigan
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Detroit, Michigan, United States, 48201
- Wayne State University
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New Mexico
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Albuquerque, New Mexico, United States, 87131
- University of New Mexico
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North Carolina
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Charlotte, North Carolina, United States, 27157
- Wake Forest University
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Durham, North Carolina, United States, 27710
- Duke University
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Durham, North Carolina, United States, 27705
- RTI International
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Ohio
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Cincinnati, Ohio, United States, 45267
- Cincinnati Children's Medical Center
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Cleveland, Ohio, United States, 44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Rhode Island
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Providence, Rhode Island, United States, 02905
- Brown University, Women & Infants Hospital of Rhode Island
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Tennessee
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Memphis, Tennessee, United States, 38163
- University of Tennessee
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Texas
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Dallas, Texas, United States, 75235
- University of Texas Southwestern Medical Center at Dallas
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Houston, Texas, United States, 77030
- University of Texas Health Science Center at Houston
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Infants 401-1,000 grams at birth
Exclusion Criteria:
- >72 hours of age
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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Pro-cytokines increased and anti-inflammatory cytokines decreased
Time Frame: At birth and/or up to Day 3±1
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At birth and/or up to Day 3±1
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Type and severity of CP and other neurodevelopmental handicaps, the appearance of PVL, and neonatal mortality
Time Frame: 18-22 months corrected age
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18-22 months corrected age
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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
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At birth
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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
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Up to Day of life 21
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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
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Up to Day of life 21
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shahnaz Duara, MD, University of Miami
- Principal Investigator: Michele C. Walsh, MD MS, Case Western Reserve University, Rainbow Babies & Children's Hospital
- Principal Investigator: Jon E. Tyson, MD MPH, The University of Texas Health Science Center, Houston
Publications and helpful links
General Publications
- Ambalavanan N, Carlo WA, D'Angio CT, McDonald SA, Das A, Schendel D, Thorsen P, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Cytokines associated with bronchopulmonary dysplasia or death in extremely low birth weight infants. Pediatrics. 2009 Apr;123(4):1132-41. doi: 10.1542/peds.2008-0526.
- Natarajan G, Shankaran S, McDonald SA, DAS A, Stoll BJ, Higgins RD, Thorsen P, Skogstrand K, Hougaard DM, Carlo WA; NICHD neonatal research network. Circulating beta chemokine and MMP 9 as markers of oxidative injury in extremely low birth weight infants. Pediatr Res. 2010 Jan;67(1):77-82. doi: 10.1203/PDR.0b013e3181c0b16c.
- Sood BG, Madan A, Saha S, Schendel D, Thorsen P, Skogstrand K, Hougaard D, Shankaran S, Carlo W; NICHD neonatal research network. Perinatal systemic inflammatory response syndrome and retinopathy of prematurity. Pediatr Res. 2010 Apr;67(4):394-400. doi: 10.1203/PDR.0b013e3181d01a36.
- Carlo WA, McDonald SA, Tyson JE, Stoll BJ, Ehrenkranz RA, Shankaran S, Goldberg RN, Das A, Schendel D, Thorsen P, Skogstrand K, Hougaard DM, Oh W, Laptook AR, Duara S, Fanaroff AA, Donovan EF, Korones SB, Stevenson DK, Papile LA, Finer NN, O'Shea TM, Poindexter BB, Wright LL, Ambalavanan N, Higgins RD; Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network. Cytokines and neurodevelopmental outcomes in extremely low birth weight infants. J Pediatr. 2011 Dec;159(6):919-25.e3. doi: 10.1016/j.jpeds.2011.05.042. Epub 2011 Jul 27.
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- Prematurity
- Interleukin-2 (IL-2)
- NICHD Neonatal Research Network
- Very Low Birth Weight (VLBW)
- Extremely Low Birth Weight (ELBW)
- Pro-inflammatory cytokines
- Interleukin-8 (IL-8)
- Anti-inflammatory cytokines
- Interleukin-1 (IL-1β)
- Interleukin-3 (IL-3)
- Interleukin-9 (IL-9)
- Tumor necrosis factor-α (TNF-α)
- Regulated upon Activation, Normal T-cell Expressed and Secreted (RANTES)
Additional Relevant MeSH Terms
Other Study ID Numbers
- NICHD-NRN-0022
- M01RR000633 (U.S. NIH Grant/Contract)
- U10HD021364 (U.S. NIH Grant/Contract)
- U10HD021373 (U.S. NIH Grant/Contract)
- U10HD021385 (U.S. NIH Grant/Contract)
- U10HD027851 (U.S. NIH Grant/Contract)
- U10HD027853 (U.S. NIH Grant/Contract)
- U10HD027856 (U.S. NIH Grant/Contract)
- U10HD027871 (U.S. NIH Grant/Contract)
- U10HD027880 (U.S. NIH Grant/Contract)
- U10HD027904 (U.S. NIH Grant/Contract)
- U10HD034216 (U.S. NIH Grant/Contract)
- U10HD040492 (U.S. NIH Grant/Contract)
- U10HD040689 (U.S. NIH Grant/Contract)
- U10HD021415 (U.S. NIH Grant/Contract)
- U10HD027881 (U.S. NIH Grant/Contract)
- M01RR008084 (U.S. NIH Grant/Contract)
- M01RR006022 (U.S. NIH Grant/Contract)
- M01RR000750 (U.S. NIH Grant/Contract)
- M01RR000070 (U.S. NIH Grant/Contract)
- M01RR000997 (U.S. NIH Grant/Contract)
- U10HD021397 (U.S. NIH Grant/Contract)
- U10HD040461 (U.S. NIH Grant/Contract)
- U10HD040498 (U.S. NIH Grant/Contract)
- M01RR000032 (U.S. NIH Grant/Contract)
- M01RR000039 (U.S. NIH Grant/Contract)
- M01RR000080 (U.S. NIH Grant/Contract)
- M01RR007122 (U.S. NIH Grant/Contract)
- M01RR016587 (U.S. NIH Grant/Contract)
- M01RR000030 (U.S. NIH Grant/Contract)
- U01HD036790 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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