Sparking Potential, Revealing Infant Neurocognitive Traits

NCT07390136 | Recruiting

• 3 other identifiers: 2024-0452UWMSN | SMPH | NRL NeurologyProtocol Version 5/3/2024
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Healthy Participants; Perinatal Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  Assessed at the 12,18, and 24-month time points

• 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.

  Assessed at the 6 and 12-month time points

Secondary Outcomes (9)

• Confusion, Hubbub and Order Scale (CHAOS)

  Assessed at the 6, 9,12, and 24-month time point

• Parental Stress Scale

  Assessed at the 6,12,18, and 24-month time points

• Parenting Daily Hassle (PDH) Scales: Frequency Score

  Assessed at the 6,12,18, and 24-month time point

• Parenting Daily Hassle (PDH) Scales: Intensity Score

  Assessed at the 6,12,18, and 24-month time point

• Pediatric Quality of Life Inventory (Peds-QL)

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

Study Arms (2)

Children with perinatal brain injuries

Children 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 Children

Children 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.

Eligibility Criteria

• Age: 3 Months - 24 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Infants ages 6-24 months located across the United States and internationally.

You may qualify if:

• 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 infants with no prior neurological (brain disorder) history

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin-Madison School of Medicine and Public Health

Madison, Wisconsin, 53726, United States

RECRUITING

Related Publications (1)

• 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.

  PMID: 23711103 BACKGROUND

Study Officials

• Melisa Carrasco McCaul, MD, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Melisa Carrasco McCaul, MD, PhD

CONTACT

608-577-2415; carrascomccaul@neurology.wisc.edu

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2026
• First Posted: February 5, 2026
• Study Start: July 30, 2024
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: February 9, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)