What this study is
The goal of this behavioral-interventional study is to learn if the Abecedarian Approach implemented virtually for children ages 0-5 with a history of Hypoxic Ischaemic Encephalopathy (HIE) and/or premature birth produces the same effects as when administered at in-person facilities.
What's being tested
- Abecedarian Approach
Intervention · BEHAVIORAL
The Abecedarian Approach is an early childhood behavioral education program that aims to improve the learning and cognitive development of children in high-risk or at-risk communities. This study will test the efficacy of implementing this approach in a virtual format.
Study details
- Sponsor
- University of Wisconsin, Madison
- Conditions
- Hypoxic Ischaemic Encephalopathy (HIE) · Premature Birth · Cerebral Palsy · Neurological Disorder
- Enrolling
- 225 people
- Starts
- 2025-06-03
- Est. completion
- 2030-03
- Design
- Single-blind, randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 5 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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).
- Parent or legal guardian will also be enrolled as a participant
- Parents must be English-speaking (able to provide consent and complete questionnaires).
You can't join if
- Not suitable for study participation due to other reasons at the discretion of the investigator.
- Infants with chromosomal abnormalities, genetic syndromes (for example, such as Down Syndrome or Trisomy18) and major congenital malformations will be excluded.
- Infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete.
- For parents or legal guardians, there are no exclusion criteria.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Wisconsin Madison
Madison, Wisconsin, United States
- Melisa Carrasco McCaul, MD, PhD · Contact608-577-2415
Recruiting
Study team
Sponsor
University of Wisconsin, Madison
Study ID 2024-1658
Principal investigator
Melisa Carrasco McCaul, MD, PhD
University of Wisconsin, Madison
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.