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Search / Trial NCT06643598

Virtual A2 Study for At Risk Children

Launched by UNIVERSITY OF WISCONSIN, MADISON · Oct 10, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

The Virtual A2 Study for At Risk Children is looking to understand how a special educational program called the Abecedarian Approach can help young children who are at risk for certain neurological conditions, like Hypoxic Ischaemic Encephalopathy (HIE) or those born prematurely. This program is usually done in person, but this study will see if it works just as well when delivered online. The researchers are currently recruiting children ages 0 to 5 who have a history of these conditions, and their parents or legal guardians will also be part of the study.

To be eligible, children must have been diagnosed with HIE or be born very prematurely (before 28 weeks of pregnancy). It's important that the parent or guardian is able to speak English, as they will need to provide consent and fill out some questionnaires. Participants can expect to engage in activities that aim to support their child's development from the comfort of their home. This study is an exciting opportunity to help improve educational approaches for at-risk children while also ensuring that they have the support they need during their early years.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. IPNH-NDCP patients, including:
  • Term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or
  • premature children (born at less than 28 weeks gestational age).
  • 2. Parent or legal guardian will also be enrolled as a participant
  • 3. Parents must be English-speaking (able to provide consent and complete questionnaires).
  • Exclusion Criteria:
  • 1. Not suitable for study participation due to other reasons at the discretion of the investigator.
  • 2. Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
  • 3. Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
  • 4. For parents or legal guardians, there are no exclusion criteria.

About University Of Wisconsin, Madison

The University of Wisconsin-Madison is a leading research institution renowned for its commitment to advancing healthcare through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its extensive resources, including cutting-edge facilities and a diverse pool of expert researchers, to conduct rigorous studies that address critical health challenges. The institution's focus on translating research findings into practical applications fosters the development of new treatments and interventions, ultimately contributing to improved patient outcomes and public health initiatives. As a sponsor of clinical trials, the University of Wisconsin-Madison is dedicated to upholding the highest ethical standards and ensuring participant safety throughout the research process.

Locations

Madison, Wisconsin, United States

Patients applied

0 patients applied

Trial Officials

Melisa Carrasco McCaul, MD, PhD

Principal Investigator

University of Wisconsin, Madison

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported