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NCT Number: NCT07413900

Biomarkers Study in Infants With Prior Neonatal Brain Injury

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.

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Key information

Age range

3 month–24 month

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin Madison University Hospital

Madison, Wisconsin, 53715, United States

Location status: Recruiting

Location contact

Melisa Carrasco McCaul, MD, PhD

CONTACT

[email protected]

608-577-2415

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

Secondary outcomes

  1. Reilly Role Overload Questionnaire

    Time frame: Assessed at the 6,12 and 18 month time points

    In the Reilly Role Overload questionnaire, parents of child participants rate the frequency of feeling overwhelmed by role demands; item responses are summed to create a total role overload score. Total scores range from 13 to 65, with higher scores indicating greater perceived role overload due to excessive demands relative to time and energy.

  2. Confusion, Hubbub and Order Scale (CHAOS)

    Time frame: Assessed at the 6,12 and 18 month time points

    Parents and/or Caregivers rate items describing household noise, crowding, and routine; responses are summed to create a total CHAOS score. The CHAOS total score ranges from 15 to 60, with higher scores indicating a more chaotic, noisy, and disorganized home environment; scores below 25 typically reflect lower chaos, whereas scores above 35 suggest high household chaos.

  3. Parenting Daily Hassle (PDH) Scales: Intensity Score

    Time frame: Assessed at the 6, 12 and 18 month time points

    A parent-report measure assessing the frequency and intensity of everyday parenting stressors (e.g., child demands, disruptions to routines); item ratings are summed or averaged to yield frequency and intensity scores. On the PDH Scale, intensity scores range from 0 to 100 with higher totals indicating more frequent and/or more stressful everyday parenting hassles.

  4. Parenting Daily Hassle (PDH) Scales: Frequency Score

    Time frame: Assessed at the 6, 12 and 18 month time points

    A parent-report measure assessing the frequency and intensity of everyday parenting stressors (e.g., child demands, disruptions to routines); item ratings are summed or averaged to yield frequency and intensity scores. On the PDH Scale, frequency scores range from 0 to 80 with higher totals indicating more frequent and/or more stressful everyday parenting hassles.

  5. Parental Stress Scale

    Time frame: Assessed at the 6, 12 and 18 month time points

    A questionnaire which measures stress and satisfaction associated with parenting; items are summed to create a total parental stress score. On the Parental Stress Scale, total scores range from 18 to 90, with higher scores indicating greater levels of parental stress and lower scores reflecting lower stress and more satisfaction in the parenting role.

  6. Early Executive Function Questionnaire: EEFQ

    Time frame: Assessed at the 6, 12 and 18 month time points

    A questionnaire is given to parents that assesses what executive functions children are exhibiting. More functions exhibited means further along in executive function development. The (EEFQ uses parent ratings on a 7-point scale for 31 items, with subscale and composite scores averaging between 1 and 7 - higher scores indicate stronger emerging executive function behaviors in infants and toddlers

  7. Bayley Assessment

    Time frame: Assessed at the 6, 12 and 18 month time points

    The Bayley is a cognitive and motor assessment conducted by an interventionalist to assess a child's development in these domains. The highest possible score on a subtest or subdomain is 19, and the lowest score is 1. Scores from 8-12 are considered average.

Study contacts

Contact information is provided by the study sponsor or research team.

Melisa Carrasco McCaul, MD, PhD

CONTACT

[email protected]

608-577-2415

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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