What this study is
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.
Study details
- Official title
- Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury
- Sponsor
- University of Wisconsin, Madison
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy · Perinatal Anoxic-ischemic Brain Injury · Premature Birth · Healthy Participants
- Enrolling
- 100 people
- Starts
- 2023-03-13
- Est. completion
- 2030-03-15
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 3 Months – 24 MonthsSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Wisconsin Madison University Hospital
Madison, Wisconsin, United States
- Melisa Carrasco McCaul, MD, PhD · Contact608-577-2415carrascomccaul@neurology.wisc.edu
Recruiting
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2021-1625
Principal investigator
Melisa Carrasco McCaul, MD, PhD
University of Wisconsin, Madison
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.