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

Not Applicable

Recruiting

• Conditions: Development, Infant
• Interventions: Behavioral: Neonatal Massage

• Registration Number: NCT05843396
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-23
• Study First Submitted QC: 2023-04-24
• Study First Posted: 2023-05-06
• Study Start: 2025-03-24
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-09
• Last Update Posted: 2025-05-14
• Primary Completion: 2029-03
• Study Completion: 2030-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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
• Non-singleton pregnancy (e.g., twins)
• Gestational Age <36 weeks (neonates)
• Neonatal encephalopathy (neonates)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neonatal Massage Received	Neonatal Massage	-

Primary Outcome Measures

Name	Time	Method
Change in correlated brain activity among functional brain areas in the somatomotor cortex	up to 3 months	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.

Trial Locations

Locations (2)

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States