Biomarkers Study in Infants With Prior Neonatal Brain Injury

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3-24
SponsorUniversity of Wisconsin, Madison

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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 diagnosed during the neonatal period with hypoxic-ischemic encephalopathy,

Children born at a premature gestational age (born at less than 32 weeks gestational age).

Disqualifiers

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)

Trial population

Infants ages 6-24 months located across the United States and internationally. Must be able to travel to Madison, WI.

Trial design

Design model

Case-control

Time perspective

Cross-sectional

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 2 trial groups
Group A: Children with perinatal brain injury
Group B: Healthy Children

Trial outcomes

Primary outcomes

1

Infant Attention Task (IAT) measured in seconds

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.

Time frame
Assessed at the 6,12 and 18 month time-points
2

A not B Task

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.

Time frame
Assessed at the 6,12 and 18 month time points
3

EEG Power in Delta and Theta Bands

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.

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

Secondary outcomes

1

Reilly Role Overload Questionnaire

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.

Time frame
Assessed at the 6,12 and 18 month time points
2

Confusion, Hubbub and Order Scale (CHAOS)

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.

Time frame
Assessed at the 6,12 and 18 month time points
3

Parenting Daily Hassle (PDH) Scales: Intensity Score

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.

Time frame
Assessed at the 6, 12 and 18 month time points
4

Parenting Daily Hassle (PDH) Scales: Frequency Score

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.

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

Other outcomes

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