NCT07413900 · University of Wisconsin, Madison
Biomarkers Study in Infants With Prior Neonatal Brain Injury
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Infant Attention Task (IAT) measured in seconds
Time frame: Assessed 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 Task
Time frame: Assessed 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 Bands
Time frame: Assessed 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Madison, Wisconsin
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Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 17, 2026 · Source of record for eligibility and locations