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

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.

Study Overview

• Status: Recruiting
• Conditions: Development, Infant
• Intervention / Treatment: Behavioral: Neonatal Massage

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chad Sylvester, MD/PhD; Phone Number: (314) 286-1700; Email: chad.sylvester@wustl.edu
• Study Contact Backup: Name: Victoria Brooks; Phone Number: 3144970223; Email: victoria.day@wustl.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota
      • Sub-Investigator: Julia Moser
      • Contact: Kristina Hufnagle; Phone Number: 612-625-5000; Email: hufna006@umn.edu
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Principal Investigator: Chad Sylvester, MD, PhD
      • Contact: Victoria Brooks; Phone Number: 314-312-2684; Email: victoria.day@wustl.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• English speaking
• Ability to give informed consent

Exclusion Criteria:

• Prisoners (vulnerable population)
• Pregnant women <18 years of age
• Active psychosis, mania, suicidal ideation (safety)
• Active substance dependence
• Gestational Age <35 weeks (neonates)
• Neonatal encephalopathy (neonates)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Neonatal Massage Received	Behavioral: Neonatal Massage; caregivers providing therapeutic touch techniques on their neonate
No Intervention: No Massage Received

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in correlated brain activity among functional brain areas in the somatomotor cortex	Brain activity is measured across the brain with functional magnetic resonance imaging (fMRI) before and after the intervention. The timeseries of brain activity will be extracted from each of the subject-specific parcels of the somatomotor network (SMN). Parcels will be divided into those that represent the upper versus lower extremity. The average of the pairwise correlations in the timeseries between upper and lower extremity parcels is the "cross-effector SMN functional connectivity" that is the primary measure. This measure will be computed before and after the intervention; we predict a decrease in cross-effector SMN functional connectivity following the intervention.	up to 3 months

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Collaborators: University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): March 31, 2025
• Primary Completion (Estimated): August 1, 2029
• Study Completion (Estimated): July 1, 2030

Study Registration Dates

• First Submitted: January 23, 2023
• First Submitted That Met QC Criteria: April 24, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 29, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 202404186

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No