Sparking Potential, Revealing Infant Neurocognitive Traits (SPRINT)

University of Wisconsin (UW)

Status: Enrolling

Conditions: Healthy Participants; Perinatal Brain Injury

Study type: Observational

Funder types: Other

Identifiers

NCT07390136

Protocol Version 5/3/2024 (Other Identifier)

UWMSN | SMPH | NRL Neurology (Other Identifier)

2024-0452

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 24 months old

Volunteers: Accepts Healthy Volunteers

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 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 design

200 participants in 2 patient groups

Children with perinatal brain injuries

Description:

Children ages 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

Description:

Children ages 6 months - 24 months of age with no prior history of a brain and/or cardiac illness early in life.