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Perinatal Brain InjurySPRINTNCT07390136

Sparking Potential, Revealing Infant Neurocognitive Traits

An observational study of Perinatal Brain Injury and Healthy Participants, run by University of Wisconsin, Madison at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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 virtual game and assessments. Read more about this study

Who is it for?
Ages 3 to 24 monthsHealthy volunteers can take part
Conditions the study is for
Perinatal Brain Injury, Healthy Participants
How many people
200 participants
Where
1 siteUnited States
Study dates
30 Jul 2024to Jul 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.

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.

Melisa Carrasco McCaul, MD, PhD contact

608-577-2415

carrascomccaul@neurology.wisc.edu

United States1 site, 1 recruiting
  • University of Wisconsin-Madison School of Medicine and Public Health

    Madison, Wisconsin, 53726

    Melisa Carrasco McCaul, MD, PhD, 608-577-2415

    Recruiting

Other trials in United States

About this study

Official title: SPRINT: Sparking Potential, Revealing Infant Neurocognitive Traits

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 virtual game and assessments. Parents will be asked to fill out questionnaires about their child's behavior and stress in the home. All study visits will take place online via Zoom.

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT07390136
Study groupRoleWhat they receive
Children with perinatal brain injuriesChildren ages 6 months (may be enrolled prior to 6 months) - 24 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 ChildrenChildren ages 6 months (may be enrolled prior to 6 months) - 24 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.

  1. Infant Attention Task (IAT)

    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 12,18, and 24-month time points

  2. Cognitive Adaptive Test/Clinical Linguistic & Auditory Milestone Scale (CAPUTE)

    An assessment for infants and young children that evaluates cognitive and language development. It combines two scales: CAT (Cognitive Adaptive Test) for problem-solving and adaptive skills, and CLAMS (Clinical Linguistic and Auditory Milestone Scale) for language and auditory milestones. Scores provide age-equivalent estimates of cognitive and language abilities. The CAPUTE scores are reported as developmental quotients ranging roughly from 40 to 160, with scores ≥85 considered within normal limits, 70-84 indicating borderline development, and <70 suggesting developmental delay.

    Measured: Assessed at the 6 and 12-month time points

Secondary outcomes (9)
  1. 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, 9,12, and 24-month time point

  2. 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 6,12,18, and 24-month time points

  3. 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 6,12,18, and 24-month time point

  4. 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 6,12,18, and 24-month time point

  5. Pediatric Quality of Life Inventory (Peds-QL)

    The PedsQL is an inventory of statements scored by reverse-scoring responses to a 5-point Likert scale and then transforming them to a 0-100 scale. A higher score indicates a better quality of life.

    Measured: Assessed at the 6, 9,18, and 24-month time point

  6. 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, 9,18, and 24-month time points

  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, 9,18, and 24-month time point

  8. Behavior Rating Inventory of Executive Function-Preschool (BRIEF-P)

    Behavior is reported in the BRIEF-P. Behaviors reported by parents can be used to predict later executive function exhibited by children. List of statements provided about child's behavior, parent will answer whether this is never a problem (N), sometimes a problem (S), and often a problem (O). Responses reported as participant counts, answering N more often is considered a better score. On the BRIEF-P, T-scores around 50 are average, 60-64 are slightly at risk, and 65 or higher indicate significant executive function difficulties.

    Measured: Assessed at the 24-month time point

  9. Parent Report of Children's Abilities-Revised (PARCA-R)

    The PARCA-R is a parent-completed questionnaire used to assess early cognitive and language development in young children (around 2 years old). It asks parents about their child's vocabulary, sentence use, and nonverbal skills. Parents' responses are summed to generate language, nonverbal, and total cognitive scores. Scores have a mean of 100, with scores around 100 indicating typical cognitive and language development at approx. 2 years, lower scores suggesting possible delay, and higher scores reflecting stronger development

    Measured: Assessed at the 24-month time point

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2026
  2. Study start30 Jul 2024
  3. Primary completionJul 2030 (estimated)
  4. Study completionJul 2030 (estimated)

Resources

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
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07390136
Sponsor's protocol ID
2024-0452
Other IDs
UWMSN | SMPH | NRL Neurology, Protocol Version 5/3/2024
Acronym
SPRINT
Status last verified
Feb 2026
First submitted
28 Jan 2026
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Cuevas K, Bell MA. Infant attention and early childhood executive function. Child Dev. 2014 Mar-Apr;85(2):397-404. doi: 10.1111/cdev.12126. Epub 2013 May 24.

    PubMed 23711103

Questions about this trial

What is this clinical trial studying?

An observational study of Perinatal Brain Injury and Healthy Participants, 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 9 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) (time frame: Assessed at the 12,18, and 24-month time points). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07390136, which also lists 1 linked publication.

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 9 Feb 2026.

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