NCT05843396

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
51mo left

Started Mar 2025

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress21%
Mar 2025Jul 2030

First Submitted

Initial submission to the registry

January 23, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 6, 2023

Completed
1.9 years until next milestone

Study Start

First participant enrolled

March 31, 2025

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2029

Expected
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2030

Last Updated

May 1, 2026

Status Verified

April 1, 2026

Enrollment Period

4.3 years

First QC Date

January 23, 2023

Last Update Submit

April 29, 2026

Conditions

Development, Infant

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Neonatal Massage Received

ACTIVE COMPARATOR
Behavioral: Neonatal Massage

No Massage Received

NO INTERVENTION

Interventions

Neonatal MassageBEHAVIORAL

caregivers providing therapeutic touch techniques on their neonate

Neonatal Massage Received

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • English speaking
  • Ability to give informed consent

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Minnesota

Minneapolis, Minnesota, 55455, United States

RECRUITING

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Central Study Contacts

Chad Sylvester, MD/PhD

CONTACT

(314) 286-1700chad.sylvester@wustl.edu

Victoria Brooks

CONTACT

3144970223victoria.day@wustl.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 23, 2023

First Posted

May 6, 2023

Study Start

March 31, 2025

Primary Completion (Estimated)

August 1, 2029

Study Completion (Estimated)

July 1, 2030

Last Updated

May 1, 2026

Record last verified: 2026-04

Locations

US(2)