HIE - Hypoxic - Ischemic EncephalopathyNCT07413900
Biomarkers Study in Infants With Prior Neonatal Brain Injury
An observational study of HIE - Hypoxic - Ischemic Encephalopathy and Perinatal Anoxic-ischemic Brain Injury, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 3 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 15 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: Infants ages 6-24 months located across the United States and internationally. Must be able to travel to Madison, WI.
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Wisconsin Madison University Hospital
Madison, Wisconsin, 53715
Melisa Carrasco McCaul, MD, PhD, 608-577-2415, carrascomccaul@neurology.wisc.edu
About this study
Official title: Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among 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.
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. ( | |
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at the 6,12 and 18 month time-points
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.
Measured: Assessed at the 6,12 and 18 month time points
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.
Measured: Assessed at the 6,12 and 18 month time points
Secondary outcomes (7)
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.
Measured: Assessed at the 6,12 and 18 month time points
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.
Measured: Assessed at the 6,12 and 18 month time points
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.
Measured: Assessed at the 6, 12 and 18 month time points
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.
Measured: Assessed at the 6, 12 and 18 month time points
Parental Stress Scale
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.
Measured: Assessed at the 6, 12 and 18 month time points
Early Executive Function Questionnaire: EEFQ
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
Measured: Assessed at the 6, 12 and 18 month time points
Bayley Assessment
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.
Measured: Assessed at the 6, 12 and 18 month time points
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start13 Mar 2023
- Primary completion15 Mar 2030 (estimated)
- Study completion15 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIE - Hypoxic - Ischemic EncephalopathyStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Melisa Carrasco McCaul, MD, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413900
- Sponsor's protocol ID
- 2021-1625
- Other IDs
- SMPH | NRL Neurology, Protocol Version 11/22/2024
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury
- ClinicalTrials.gov ID
- NCT07413900
- Acronym / sponsor ID
- 2021-1625
- Conditions
- HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 15 Mar 2030 (estimated)
- Study completion
- 15 Mar 2030 (estimated)
- First posted
- 17 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. ( |
| 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. |
Who may qualify
- Ages
- 3 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Infants ages 6-24 months located across the United States and internationally. Must be able to travel to Madison, WI.
Key inclusion criteria (9 listed)
- 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:
- Healthy control participants meeting inclusion criteria will include:
- 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.
Key exclusion criteria (7 listed)
- Healthy infants to be included in the control group will not have:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
7 secondary outcomes
Reilly Role Overload Questionnaire
Time frame: Assessed at the 6,12 and 18 month time points
Confusion, Hubbub and Order Scale (CHAOS)
Time frame: Assessed at the 6,12 and 18 month time points
Parenting Daily Hassle (PDH) Scales: Intensity Score
Time frame: Assessed at the 6, 12 and 18 month time points
Parenting Daily Hassle (PDH) Scales: Frequency Score
Time frame: Assessed at the 6, 12 and 18 month time points
Parental Stress Scale
Time frame: Assessed at the 6, 12 and 18 month time points
Early Executive Function Questionnaire: EEFQ
Time frame: Assessed at the 6, 12 and 18 month time points
Bayley Assessment
Time frame: Assessed at the 6, 12 and 18 month time points
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Melisa Carrasco McCaul, MD, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HIE - Hypoxic - Ischemic Encephalopathy and Perinatal Anoxic-ischemic Brain Injury, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Melisa Carrasco McCaul, MD, PhD (608-577-2415, carrascomccaul@neurology.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infant Attention Task (IAT) measured in seconds (time frame: Assessed at the 6,12 and 18 month time-points). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.