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A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death


N/A
N/A
72 Hours
Not Enrolling
Both
Infant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, Premature, Cerebral Palsy

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Trial Information

A Study to Determine If Inflammatory Cytokines Are Associated With Perinatal Brain Injury and Long Term Neurodevelopmental Handicap or Death


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.


Inclusion Criteria:



- Infants 401-1,000 grams at birth

Exclusion Criteria:

- >72 hours of age

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Pro-cytokines increased and anti-inflammatory cytokines decreased

Outcome Time Frame:

At birth and/or up to Day 3±1

Safety Issue:

No

Principal Investigator

William Oh, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Brown University, Women & Infants Hospital of Rhode Island

Authority:

United States: Federal Government

Study ID:

NICHD-NRN-0022

NCT ID:

NCT01035697

Start Date:

July 1999

Completion Date:

May 2004

Related Keywords:

  • Infant, Newborn
  • Infant, Low Birth Weight
  • Infant, Small for Gestational Age
  • Infant, Premature
  • Cerebral Palsy
  • 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)
  • Birth Weight
  • Cerebral Palsy
  • Brain Injuries

Name

Location

Wake Forest UniversityWinston-Salem, North Carolina  27103
University of AlabamaBirmingham, Alabama  
Stanford UniversityStanford, California  94305
University of Texas Southwestern Medical Center at DallasDallas, Texas  75235-8897
University of Texas Health Science Center at HoustonHouston, Texas  77225
Duke UniversityDurham, North Carolina  27710
University of California at San DiegoLa Jolla, California  92093
Yale UniversityNew Haven, Connecticut  06520
Emory UniversityAtlanta, Georgia  30322
Wayne State UniversityDetroit, Michigan  48202
University of New MexicoAlbuquerque, New Mexico  87131
University of MiamiMiami, Florida  33136
Indiana UniversityIndianapolis, Indiana  46202
University of TennesseeMemphis, Tennessee  38163
RTI InternationalDurham, North Carolina  27705
Cincinnati Children's Medical CenterCincinnati, Ohio  45267
Case Western Reserve University, Rainbow Babies and Children's HospitalCleveland, Ohio  44106
Brown University, Women & Infants Hospital of Rhode IslandProvidence, Rhode Island  02905