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.

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Key information

Conditions

Development, Infant

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota, Minneapolis, Minnesota, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Neonatal Massage

Behavioral

caregivers providing therapeutic touch techniques on their neonate

Primary outcomes

Change in correlated brain activity among functional brain areas in the somatomotor cortex

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chad Sylvester, MD/PhD

CONTACT

[email protected]

(314) 286-1700

Victoria Brooks

CONTACT

[email protected]

3144970223

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

University of Minnesota

Registry information

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: May 6, 2023
Registry last updated: May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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