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Recruiting NCT06643598

NCT06643598 Healing Tiny Minds: Rural Recovery Through Virtual and Lived Experience Care

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Clinical Trial Summary
NCT ID NCT06643598
Status Recruiting
Phase
Sponsor University of Wisconsin, Madison
Condition Hypoxic Ischaemic Encephalopathy (HIE)
Study Type INTERVENTIONAL
Enrollment 225 participants
Start Date 2025-06-03
Primary Completion 2030-03

Eligibility & Interventions

Sex All sexes
Min Age N/A
Max Age 5 Years
Study Type INTERVENTIONAL
Interventions
Abecedarian Approach

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 225 participants in total. It began in 2025-06-03 with a primary completion date of 2030-03.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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.

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.

Contact & Investigator

Central Contact

Melisa Carrasco McCaul, MD, PhD

✉ carrascomccaul@neurology.wisc.edu

📞 608-577-2415

Principal Investigator

Melisa Carrasco McCaul, MD, PhD

PRINCIPAL INVESTIGATOR

University of Wisconsin, Madison

Frequently Asked Questions

Who can join the NCT06643598 clinical trial?

This trial is open to participants of all sexes, up to 5 Years, studying Hypoxic Ischaemic Encephalopathy (HIE). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT06643598 currently recruiting?

Yes, NCT06643598 is actively recruiting participants. Contact the research team at carrascomccaul@neurology.wisc.edu for enrollment information.

Where is the NCT06643598 trial being conducted?

This trial is being conducted at Madison, United States.

Who is sponsoring the NCT06643598 clinical trial?

NCT06643598 is sponsored by University of Wisconsin, Madison. The principal investigator is Melisa Carrasco McCaul, MD, PhD at University of Wisconsin, Madison. The trial plans to enroll 225 participants.

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