NCT07413900 Biomarkers Study in Infants With Prior Neonatal Brain Injury
| NCT ID | NCT07413900 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Wisconsin, Madison |
| Condition | HIE - Hypoxic - Ischemic Encephalopathy |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2023-03-13 |
| Primary Completion | 2030-03-15 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2023-03-13 with a primary completion date of 2030-03-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Melisa Carrasco McCaul, MD, PhD
PRINCIPAL INVESTIGATOR
University of Wisconsin, Madison
Frequently Asked Questions
Who can join the NCT07413900 clinical trial?
This trial is open to participants of all sexes, aged 3 Months or older, up to 24 Months, studying HIE - Hypoxic - Ischemic Encephalopathy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07413900 currently recruiting?
Yes, NCT07413900 is actively recruiting participants. Contact the research team at carrascomccaul@neurology.wisc.edu for enrollment information.
Where is the NCT07413900 trial being conducted?
This trial is being conducted at Madison, United States.
Who is sponsoring the NCT07413900 clinical trial?
NCT07413900 is sponsored by University of Wisconsin, Madison. The principal investigator is Melisa Carrasco McCaul, MD, PhD at University of Wisconsin, Madison. The trial plans to enroll 100 participants.