Trial record 17 of 17 for:
necrotizing enterocolitis | NICHD [Lead]
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
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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:
MedlinePlus related topics:
Birth Weight
Cerebral Palsy
Paralysis
Premature Babies
Traumatic Brain Injury
U.S. FDA Resources
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) |
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
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
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 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: | 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 Cerebral Palsy Brain Injuries Body Weight Signs and Symptoms Brain Damage, Chronic |
Brain Diseases Central Nervous System Diseases Nervous System Diseases Craniocerebral Trauma Trauma, Nervous System Wounds and Injuries |
ClinicalTrials.gov processed this record on May 21, 2013