Biomarkers in infants with prior neonatal brain injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: carrascomccaul@neurology.wisc.edu
• Phone: 608-577-2415

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.