Recruiting

Cognitive Development

Sponsor:

University of Wisconsin, Madison

Code:

NCT07413900

Conditions

HIE - Hypoxic - Ischemic Encephalopathy

Perinatal Anoxic-ischemic Brain Injury

Premature Birth

Healthy Participants

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Study Details

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

Study ID

NCT07413900

Start date

Mar 13, 2023

Status verified date

Feb, 2026

Completion date

Mar 15, 2030

Anticipated

Primary completion date

Mar 15, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 2

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 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.

Exclusion Criteria:

  • 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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Infant Attention Task (IAT) measured in seconds [ Time Frame: Assessed at the 6,12 and 18 month time-points ]
  • A not B Task [ Time Frame: Assessed at the 6,12 and 18 month time points ]
  • EEG Power in Delta and Theta Bands [ Time Frame: Assessed at the 6,12 and 18 month time points ]

Central Contacts and Locations

Central contacts

Melisa Carrasco McCaul, MD, PhD

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

Locations

University of Wisconsin Madison University Hospital

Recruiting

Madison, Wisconsin, United States, 53715

Contacts

Melisa Carrasco McCaul, MD, PhD

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

More Information

Sponsor

University of Wisconsin, Madison

Last update posted

Feb 17, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Wisconsin, Madison on 2026-02-17.