Actively Recruiting
Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury
Led by University of Wisconsin, Madison · Updated on 2026-02-17
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research focuses on the long-term cognitive development of children, including both healthy infants and those who experienced a perinatal brain injury such as hypoxic-ischemic encephalopathy, cerebral palsy, or premature birth. The study aims to predict executive dysfunction and cognitive outcomes by assessing differences between children with prior brain injuries and healthy controls. It is an observational study sponsored by the University of Wisconsin, Madison. Children aged 3 to 24 months, including those diagnosed with perinatal brain injuries and healthy infants without neurological history, participate in this study. Participants complete in-person games and assessments at the University Hospital, including EEG evaluations measuring brain activity in delta and theta bands. The study includes repeated assessments at 6, 12, and 18 months to track development. During the study, children engage in cognitive tasks such as the Infant Attention Task and the A not B Task. Parents also complete questionnaires about their child's behavior, stress levels, and daily hassles. Researchers monitor outcomes through standardized tests like the Bayley Assessment and various parenting stress scales. Data collection occurs at multiple time points over an 18-month period to understand developmental changes and factors influencing cognitive outcomes.
CONDITIONS
Brief Title
Biomarkers Study in Infants With Prior Neonatal Brain Injury
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child-parent dyads are invited to participate.
- Children aged 3 to 24 months with or without a history of perinatal brain injury can join.
- Children with perinatal brain injury include those diagnosed with hypoxic-ischemic encephalopathy during the neonatal period.
- Children born prematurely before 32 weeks gestational age are eligible.
- Children diagnosed with cerebral palsy are eligible.
- Healthy infants without any prior neurological history can participate.
- Parents or legal guardians of eligible children may participate by providing consent.
You will not qualify if you...
- Healthy infants in the control group must not have any prior brain injury.
- Healthy infants must not have a diagnosis of cerebral palsy or any neurological disorder.
- Healthy infants must not have been admitted to the Neonatal Intensive Care Unit (NICU).
- Children with chromosomal abnormalities, genetic syndromes, or major congenital malformations are excluded.
- There are no exclusion criteria for parents or legal guardians.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 18 months
Participants are observed over time to assess cognitive and executive function development through various assessments.
Visits at 6, 12, and 18 months of age
Trial Site Locations
Total: 1 location
1
University of Wisconsin Madison University Hospital
Madison, Wisconsin, United States, 53715
Actively Recruiting
Research Team
M
Melisa Carrasco McCaul, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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