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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorWashington University School of Medicine

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

English speaking

Ability to give informed consent

Disqualifiers

Prisoners (vulnerable population)

Pregnant women <18 years of age

Active psychosis, mania, suicidal ideation (safety)

Active substance dependence

Trial design

Design model

Parallel

Treatments tested in this trial

  • Neonatal Massage

    Behavioral

    caregivers providing therapeutic touch techniques on their neonate

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Neonatal Massage ReceivedActive comparator 1 intervention
Group B: No Massage ReceivedNo intervention 0 interventions

Trial outcomes

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.

Time frame
up to 3 months

Secondary outcomes

Other outcomes

Sponsors and contacts

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Washington University School of Medicine

Lead sponsor

University of Minnesota

Collaborator