Inflammatory Cytokines Associated With Perinatal Brain Injury

N

NICHD Neonatal Research Network

Status

Completed

Conditions

Infant, Low Birth Weight
Infant, Newborn
Infant, Small for Gestational Age
Cerebral Palsy
Infant, Premature

Study type

Observational

Funder types

NETWORK
Other U.S. Federal agency
NIH

Identifiers

NCT01035697
M01RR016587 (U.S. NIH Grant/Contract)
M01RR000032 (U.S. NIH Grant/Contract)
M01RR006022 (U.S. NIH Grant/Contract)
U10HD021364 (U.S. NIH Grant/Contract)
U10HD027880 (U.S. NIH Grant/Contract)
U10HD027856 (U.S. NIH Grant/Contract)
U10HD027851 (U.S. NIH Grant/Contract)
U10HD040689 (U.S. NIH Grant/Contract)
M01RR000039 (U.S. NIH Grant/Contract)
M01RR008084 (U.S. NIH Grant/Contract)
U10HD027871 (U.S. NIH Grant/Contract)
U10HD021373 (U.S. NIH Grant/Contract)
U10HD021415 (U.S. NIH Grant/Contract)
M01RR000997 (U.S. NIH Grant/Contract)
M01RR000080 (U.S. NIH Grant/Contract)
NICHD-NRN-0022
U10HD027853 (U.S. NIH Grant/Contract)
M01RR000070 (U.S. NIH Grant/Contract)
U10HD040498 (U.S. NIH Grant/Contract)
M01RR000633 (U.S. NIH Grant/Contract)
U10HD040492 (U.S. NIH Grant/Contract)
M01RR007122 (U.S. NIH Grant/Contract)
M01RR000030 (U.S. NIH Grant/Contract)
U10HD027881 (U.S. NIH Grant/Contract)
M01RR000750 (U.S. NIH Grant/Contract)
U10HD021397 (U.S. NIH Grant/Contract)
U10HD034216 (U.S. NIH Grant/Contract)
U01HD036790 (U.S. NIH Grant/Contract)
U10HD021385 (U.S. NIH Grant/Contract)
U10HD027904 (U.S. NIH Grant/Contract)
U10HD040461 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,067 patients

Sex

All

Ages

Under 72 hours old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Infants 401-1,000 grams at birth

Exclusion criteria

>72 hours of age

Trial contacts and locations

18

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Data sourced from clinicaltrials.gov

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