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Biomarkers Study in Infants With Prior Neonatal Brain Injury

University of Wisconsin, Madison · NCT07413900

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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
Biomarkers Study in Infants With Prior Neonatal Brain Injury (NCT07413900) | Bored Studies