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Recruiting NCT07413900

Biomarkers Study in Infants With Prior Neonatal Brain Injury

— Observational HIE - Hypoxic - Ischemic Encephalopathy Perinatal Anoxic-ischemic Brain Injury Premature Birth Healthy Participants

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: HIE - Hypoxic - Ischemic Encephalopathy, Perinatal Anoxic-ischemic Brain Injury, Premature Birth, Healthy Participants. Basic parameters: 3 months — 24 months · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Early Biomarkers Study for Prediction of Executive Dysfunction and Cognitive Outcomes Among Infants With Prior Neonatal Brain Injury

Overview

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.

Primary outcome measures

  • 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]
Secondary outcome measures (7)
  • Reilly Role Overload Questionnaire [Time frame: Assessed at the 6,12 and 18 month time points]
  • Confusion, Hubbub and Order Scale (CHAOS) [Time frame: Assessed at the 6,12 and 18 month time points]
  • Parenting Daily Hassle (PDH) Scales: Intensity Score [Time frame: Assessed at the 6, 12 and 18 month time points]
  • Parenting Daily Hassle (PDH) Scales: Frequency Score [Time frame: Assessed at the 6, 12 and 18 month time points]
  • Parental Stress Scale [Time frame: Assessed at the 6, 12 and 18 month time points]
  • Early Executive Function Questionnaire: EEFQ [Time frame: Assessed at the 6, 12 and 18 month time points]
  • Bayley Assessment [Time frame: Assessed at the 6, 12 and 18 month time points]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Wisconsin Madison University Hospital — Madison

Identifiers

NCT: NCT07413900 · 2021-1625 · SMPH | NRL Neurology · Protocol Version 11/22/2024

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗