Biomarkers Study in Infants With Prior Neonatal Brain Injury

Part of paid clinical trials in Madison, Wisconsin.

Sponsor
University of Wisconsin, Madison
Study ID
NCT07413900
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
3 Months - 24 Months
Healthy Volunteers
Accepted

Study Details

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.

Key Dates

Start date
Mar 13, 2023
Status verified
Feb 2026
Primary completion
Mar 15, 2030
Completion
Mar 15, 2030

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: Children with perinatal brain injury
    Children ages 6 months (may be enrolled prior to 6 months) - 18 months who are diagnosed with 1) hypoxic- ischemic encephalopathy, 2) cerebral palsy, and/or 3) were born premature at less than 28 weeks gestational age. (
  • Arm: Healthy Children
    Children ages 6 months (may be enrolled prior to 6 months) - 18 months of age with no prior history of a brain and/or cardiac illness early in life.

Primary Outcome Measure

Infant Attention Task (IAT) measured in seconds [ Time Frame: Assessed at the 6,12 and 18 month time-points ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Wisconsin Madison University HospitalMadisonWisconsin53715
Melisa Carrasco McCaul, MD, PhD
[email protected]
608-577-2415

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By research site
University of Wisconsin Madison University Hospital· Madison, WI

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