Inflammatory Cytokines Associated With Perinatal Brain Injury

NICHD Neonatal Research Network1,067 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

1,067

Conditions

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

Eligibility

Sex: ALLMax age: 72 HoursHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Infants 401-1,000 grams at birth Exclusion Criteria: * \>72 hours of age

Locations (18)

University of Alabama

Birmingham, Alabama, United States

Stanford University

Palo Alto, California, United States

Outcomes

Primary Outcomes

Pro-cytokines increased and anti-inflammatory cytokines decreased

Time frame: At birth and/or up to Day 3±1

Secondary Outcomes

Type and severity of CP and other neurodevelopmental handicaps, the appearance of PVL, and neonatal mortality

Time frame: 18-22 months corrected age

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

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

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.