Inflammatory Cytokines Associated With Perinatal Brain Injury

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