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

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Washington University School of Medicine
Study ID
NCT05843396
Status
Recruiting
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Conditions

  • Development, Infant

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Accepted

Interventions

  • Neonatal Massage — BEHAVIORAL
    caregivers providing therapeutic touch techniques on their neonate

Study Details

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.

Key Dates

Start date
Mar 31, 2025
Status verified
Apr 2026
Primary completion
Aug 31, 2029
Completion
Jul 31, 2030

Study Design

Enrollment
80 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE

Arms

  • Active Comparator: Neonatal Massage Received
  • No Intervention: No Massage Received

Primary Outcome Measure

Change in correlated brain activity among functional brain areas in the somatomotor cortex [ Time Frame: up to 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of MinnesotaMinneapolisMinnesota55455
Kristina Hufnagle
[email protected]
612-625-5000
Julia Moser (SUB_INVESTIGATOR)
Washington University School of MedicineSt LouisMissouri63110
Victoria Brooks
[email protected]
314-312-2684
Chad Sylvester, MD, PhD (PRINCIPAL_INVESTIGATOR)

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By research site
University of Minnesota· Minneapolis, MNWashington University School of Medicine· St Louis, MO

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