Actively Recruiting
Brain Organization, Development, and Response to Intervention in Individual Neonates
Led by Washington University School of Medicine · Updated on 2026-05-01
80
Participants Needed
2
Research Sites
47 weeks
Total Duration
On this page
Sponsors
W
Washington University School of Medicine
Lead Sponsor
U
University of Minnesota
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to understand brain connectivity in newborn babies and to observe whether daily massage shortly after birth affects brain development. The study focuses on infants' brain activity, particularly in the somatomotor cortex region, during the first three months of life. It is designed as a randomized, interventional trial to compare outcomes between groups of babies. Participants are divided into two groups: one group receives daily neonatal massage provided by caregivers, involving therapeutic touch techniques, while the other group does not receive massage. The study will monitor changes in correlated brain activity among functional brain areas. This trial includes a single masking approach and runs from March 2025 through July 2030. During the study, babies will undergo assessments to measure brain activity changes over a period of up to three months. Researchers will collect data on brain function to evaluate the impact of massage. Caregivers and babies will be observed and monitored to ensure safety and adherence to the study procedures, with outcomes focused on brain development and organization.
CONDITIONS
Brief Title
Brain Organization, Development, and Response to Intervention in Individual Neonates
Who Can Participate
Eligibility Criteria
You may qualify if you...
- English speaking
- Ability to give informed consent
You will not qualify if you...
- Prisoners (vulnerable population)
- Pregnant women under 18 years of age
- Active psychosis, mania, suicidal ideation
- Active substance dependence
- Gestational age less than 35 weeks (neonates)
- Neonatal encephalopathy (neonates)
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 3 months
Participants receive neonatal massage therapy or no intervention as part of the study.
Trial Site Locations
Total: 2 locations
1
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Actively Recruiting
2
Washington University School of Medicine
St Louis, Missouri, United States, 63110
Actively Recruiting
Research Team
C
Chad Sylvester, MD/PhD
V
Victoria Brooks
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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