Biomarkers Study in Infants With Prior Neonatal Brain Injury
University of Wisconsin, Madison · NCT07413900
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 4 mo–2 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 100
- US sites recruiting
- 1
- Study start
- March 13, 2023
- Record last updated
- February 17, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
This research focuses on the long-term cognitive development of children, including healthy infants and those who had a perinatal brain injury. As part of this research study, children complete in-person games and assessments at UW-Madison University Hospital. Children will also take part in an EEG assessment. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home.
Conditions: HIE - Hypoxic - Ischemic Encephalopathy; Perinatal Anoxic-ischemic Brain Injury; Premature Birth; Healthy Participants
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
Inclusion Criteria
- Child-parent dyads will be recruited to the study.
- Children 3-24 months with and without a history of a perinatal brain injury (PBI) will be included in this study.
- Children with PBIs will include:
- Children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,
- Children born at a premature gestational age (born at less than 32 weeks gestational age).
- Children diagnosed with cerebral palsy
- Healthy control participants meeting inclusion criteria will include:
- healthy infants with no prior neurological (brain disorder) history
- For all parents: the only research inclusion criteria is to be the parent or legal guardian of a newborn with perinatal brain injury or healthy control participant.
Exclusion Criteria
- Healthy infants to be included in the control group will not have:
- a prior history of brain injury
- a diagnosis of cerebral palsy
- a history of a neurological disorder
- prior admission to the Neonatal Intensive Care Unit (NICU)
- Children with chromosomal abnormalities, genetic syndromes and major congenital malformations will be excluded from both the patient groups and the control group.
- Parents will have no exclusionary criteria.
Recruiting US locations
University of Wisconsin Madison University Hospital
Madison, WI 53715
Site contact: Melisa Carrasco McCaul, MD, PhD · 608-577-2415 · carrascomccaul@neurology.wisc.edu
Study contacts (from the official record)
- Melisa Carrasco McCaul, MD, PhD · 608-577-2415 · carrascomccaul@neurology.wisc.edu
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