RecruitingNot ApplicableNCT05843396

Brain Organization, Development, and Response to Intervention in Individual Neonates


Sponsor

Washington University School of Medicine

Enrollment

80 participants

Start Date

Mar 31, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to learn about brain connectivity and if massaging babies shortly after birth has an impact. Half of the recruited babies will receive massage daily while the other half will not, and differences will be observed.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study examines how the brain develops and responds to early interventions in newborns by collecting MRI brain scans and cognitive assessments. The goal is to understand normal and abnormal brain organization in newborns to improve early identification of developmental risks. **You may be eligible if...** - You are an English-speaking adult able to give informed consent (for parent or guardian participation) - Your newborn is at least 36 weeks gestational age at birth - Your newborn does not have brain injury from oxygen deprivation at birth - You are carrying or have delivered a single baby (not twins or multiples) **You may NOT be eligible if...** - You are pregnant and under 18 years old - You have active psychosis, mania, suicidal thoughts, or substance dependence - Your newborn was born before 36 weeks gestational age - You are incarcerated (a legally protected group excluded for ethical reasons) Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALNeonatal Massage

caregivers providing therapeutic touch techniques on their neonate


Locations(2)

University of Minnesota

Minneapolis, Minnesota, United States

Washington University School of Medicine

St Louis, Missouri, United States

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NCT05843396


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