Biomarkers in infants with prior neonatal brain injury

Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury

This project will test brain activity and development using games, EEG, and parent questionnaires in infants aged 3–24 months with and without prior neonatal brain injury.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 3 Months to 24 Months
• Sex: All
• Sponsor: University of Wisconsin, Madison (Academic / other)
• Locations: 1 site (Madison, Wisconsin)
• Trial ID: NCT07413900 on ClinicalTrials.gov

What this trial studies

This observational project enrolls child-parent pairs to compare infants with prior perinatal brain injury (including HIE, very preterm birth, or cerebral palsy) to healthy infants. Participants complete in-person developmental games and cognitive assessments at the University of Wisconsin–Madison hospital, undergo an EEG, and parents fill out questionnaires about behavior and home stress. The protocol is noninterventional and focuses on identifying biomarkers and patterns linked to later cognitive development. Results aim to improve understanding of early markers that predict developmental trajectories.

Who should consider this trial

Good fit: Ideal candidates are infants aged 3–24 months and their parent or legal guardian, including those with a neonatal history of HIE, prematurity under 32 weeks, or cerebral palsy, as well as healthy control infants without prior neurological problems, and families able to attend visits at UW–Madison.

Not a fit: Infants outside the 3–24 month age range, those with exclusionary neurological conditions for the control group, or families unable to travel to the study site are unlikely to benefit directly from participation.

Why it matters

Potential benefit: If successful, the findings could help identify early signs of altered brain development and support earlier referral to therapies or monitoring.

How similar studies have performed: Previous research using EEG and behavioral testing has shown promise for detecting early developmental differences after neonatal brain injury, but definitive clinical biomarkers remain limited.

Eligibility 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.

Where this trial is running

Madison, Wisconsin

• University of Wisconsin Madison University Hospital — Madison, Wisconsin, United States (Recruiting)

Study contacts

• Principal investigator: Melisa Carrasco McCaul, MD, PhD — University of Wisconsin, Madison
• Study coordinator: Melisa Carrasco McCaul, MD, PhD

Conditions HIE - Hypoxic - Ischemic Encephalopathy; Perinatal Anoxic-ischemic Brain Injury; Premature Birth; Healthy Participants