Recruiting

Massage

Sponsor:

Washington University School of Medicine

Code:

NCT05843396

Conditions

Development, Infant

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Interventions

Neonatal Massage

Study Details

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.

Conditions

Development, Infant

Study ID

NCT05843396

Start date

Mar 31, 2025

Status verified date

Aug, 2026

Completion date

Jul, 2030

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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 Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Basic Science

Interventions and Outcome Measures

Arms

active comparator: Neonatal Massage Received

no intervention: No Massage Received

Interventions

Neonatal Massage

caregivers providing therapeutic touch techniques on their neonate

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Victoria Brooks, LCSW

(314) 312-2684pipproject@wustl.edu

Locations

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Julia Moser

612-625-5000precisionbaby@umn.edu

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Victoria Brooks

314-312-2684victoria.day@wustl.edu

Principal Investigator:

Chad Sylvester, MD, PhD

More Information

Sponsor

Washington University School of Medicine

Last update posted

Aug 19, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-08-19.