Inflammatory Cytokines Associated With Perinatal Brain Injury (Cytokines)
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| ClinicalTrials.gov Identifier: NCT01035697 |
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Recruitment Status
:
Completed
First Posted
: December 21, 2009
Last Update Posted
: September 26, 2017
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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
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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.
| Condition or disease |
|---|
| Infant, Newborn Infant, Low Birth Weight Infant, Small for Gestational Age Infant, Premature Cerebral Palsy |
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 : | Observational |
| Actual Enrollment : | 1067 participants |
| 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 |
| Study Start Date : | July 1999 |
| Actual Primary Completion Date : | July 2002 |
| Actual Study Completion Date : | May 2004 |
Primary Outcome Measures
:
- Pro-cytokines increased and anti-inflammatory cytokines decreased [ Time Frame: At birth and/or up to Day 3±1 ]
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 ]
- 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 ]
- 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 ]
- 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 ]
Biospecimen Retention: Samples With DNA
Whole blood spots collected on filter paper.
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| Ages Eligible for Study: | up to 72 Hours (Child) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
Additional Information:
Publications of Results:
Keywords provided by NICHD Neonatal Research Network:
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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:
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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 |