Biomarkers Study in Infants With Prior Neonatal Brain Injury

This observational study is looking at the long-term brain development of infants, including healthy babies and those who experienced a brain injury around the time of birth (perinatal brain injury). Researchers are not testing a specific drug or intervention. Instead, they are observing how infants develop over time. They will measure things like attention using games (Infant Attention Task and A not B Task) and brain activity (EEG Power in Delta and Theta Bands) at 6, 12, and 18 months of age. This study is open to children aged 3 to 24 months, including those diagnosed with hypoxic-ischemic encephalopathy (HIE, a type of brain injury from lack of oxygen) or born prematurely (before 32 weeks). The study aims to understand how these factors relate to a child's development.

Study design
This is an observational study planning to enroll 100 participants. It is not testing a specific treatment, but rather observing development in infants.
What's involved
Your child would participate in in-person games and assessments at UW-Madison University Hospital, including an EEG assessment. Parents will also complete questionnaires about their child's behavior and stress at home.
Compensation
Not stated in the trial record.
Follow-up
Participants will be assessed at 6, 12, and 18 months of age.

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NCT07413900

Biomarkers Study in Infants With Prior Neonatal Brain Injury

Recruiting
Not specifiedAges 3–24Observational
University of Wisconsin, Madison
~100 participants
Updated 2026-02-17 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Infant Attention Task (IAT) measured in seconds
Measured over Assessed at the 6,12 and 18 month time-points
+2 more outcomes measured
HIE - Hypoxic - Ischemic Encephalopathy
Perinatal Anoxic-ischemic Brain Injury
Premature Birth
Healthy Participants
1 sites across 1 states
Wisconsin1
  • Melisa Carrasco McCaul, MD, PhD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

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Eligibility criteria

Inclusion

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 infants with no prior neurological (brain disorder) history

Exclusion

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.
  • Infant Attention Task (IAT) measured in secondsAssessed at the 6,12 and 18 month time-points

    A behavioral measure used with infants to assess attentional control and processing. Infants are presented with visual puppet stimuli four distinct "looks", and researchers record looking time, shifts in attention, or habituation patterns. More sustained attention in the early looks followed by habituation to the stimuli in the later looks often indicates better early attentional capacity. Total accumulated looking time to a stimulus in visual preference-type tasks commonly ranges from roughly 15-30+ seconds per trial, depending on the infant's age and the stimulus.

  • A not B TaskAssessed at the 6,12 and 18 month time points

    The A-not-B task is a developmental measure of object permanence, working memory, and inhibitory control in infants, requiring them to search for a hidden object after its location is changed. Performance is typically reported as the percentage of correct searches on B trials, with infants 8-9 months averaging 20-40% correct (range 0-100%), 10-11 months averaging 50-70%, and 12-month-olds reaching 75-90%, often near the maximum. Scores vary with delay length and task difficulty.

  • EEG Power in Delta and Theta BandsAssessed at the 6,12 and 18 month time points

    EEG data will be utilized to examine whether neural activity patterns are associated with later executive functioning outcomes. Specific EEG indices will be analyzed as predictors of executive functioning, with lower/higher executive functioning defined by performance on behavioral measures.