Inflammatory Cytokines Associated With Perinatal Brain Injury (Cytokines)
This study has been completed.
Sponsor:
NICHD Neonatal Research Network
Collaborators:
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)
Information provided by:
NICHD Neonatal Research Network
ClinicalTrials.gov Identifier:
NCT01035697
First received: December 17, 2009
Last updated: June 3, 2015
Last verified: June 2015
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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 NICHD Neonatal Research Network:
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) |
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 (Child) |
| 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
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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
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 | |
| RTI International | |
| Durham, North Carolina, United States, 27705 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| 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
NICHD Neonatal Research Network
Centers for Disease Control and Prevention
National Center for Research Resources (NCRR)
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 | Children's Hospital Medical Center, Cincinnati |
| 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 University |
| 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: | June 3, 2015 |
| Health Authority: | United States: Federal Government United States: Institutional Review Board |
Keywords provided by NICHD Neonatal Research Network:
|
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:
|
Brain Injuries Cerebral Palsy Birth Weight Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries Brain Damage, Chronic Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on September 27, 2016