Skip to content

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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05843396
Enrollment
80
Registered
2023-05-06
Start date
2025-03-31
Completion date
2030-07-01
Last updated
2026-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Development, Infant

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.

Interventions

caregivers providing therapeutic touch techniques on their neonate

Sponsors

Washington University School of Medicine
Lead SponsorOTHER
University of Minnesota
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Healthy volunteers
Yes

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in correlated brain activity among functional brain areas in the somatomotor cortexup to 3 monthsBrain 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.

Countries

United States

Contacts

CONTACTVictoria Brooks, LCSW
pipproject@wustl.edu(314) 312-2684

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 20, 2026