Trials / Completed

CompletedNCT01035697

Inflammatory Cytokines Associated With Perinatal Brain Injury

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

Status: Completed
Phase: —
Study type: Observational
Enrollment: 1,067 (actual)

Sponsor: NICHD Neonatal Research Network · Network
Sex: All
Age: 72 Hours
Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

Timeline

Start date: 1999-07-01
Primary completion: 2002-07-01
Completion: 2004-05-01
First posted: 2009-12-21
Last updated: 2019-03-22

Locations

18 sites across 1 country: United States

Source: ClinicalTrials.gov record NCT01035697. Inclusion in this directory is not an endorsement.