Biomarkers Study in Infants With Prior Neonatal Brain Injury

NCT07413900 | Recruiting

• 3 other identifiers: 2021-1625SMPH | NRL NeurologyProtocol Version 11/22/2024
• Study Type: observational
• Target: 100
• 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 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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Assessed at the 6,12 and 18 month time points

Secondary Outcomes (7)

• Reilly Role Overload Questionnaire

  Assessed at the 6,12 and 18 month time points

• Confusion, Hubbub and Order Scale (CHAOS)

  Assessed at the 6,12 and 18 month time points

• Parenting Daily Hassle (PDH) Scales: Intensity Score

  Assessed at the 6, 12 and 18 month time points

• Parenting Daily Hassle (PDH) Scales: Frequency Score

  Assessed at the 6, 12 and 18 month time points

• Parental Stress Scale

  Assessed at the 6, 12 and 18 month time points

Study Arms (2)

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.

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. Must be able to travel to Madison, WI.

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 University Hospital

Madison, Wisconsin, 53715, United States

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

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: February 2, 2026
• First Posted: February 17, 2026
• Study Start: March 13, 2023
• Primary Completion (Estimated): March 15, 2030
• Study Completion (Estimated): March 15, 2030
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)