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

Purpose

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.

Condition

  • Development, Infant

Eligibility

Eligible Ages
All ages
Eligible Sex
All
Accepts 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)

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Basic Science
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Neonatal Massage Received
  • Behavioral: Neonatal Massage
    caregivers providing therapeutic touch techniques on their neonate
No Intervention
No Massage Received

Recruiting Locations

Washington University in St. Louis and nearby locations

Washington University School of Medicine
St Louis, Missouri 63110
Contact:
Victoria Brooks
314-312-2684
victoria.day@wustl.edu

More Details

NCT ID
NCT05843396
Status
Recruiting
Sponsor
Washington University School of Medicine

Study Contact

Chad Sylvester, MD/PhD
(314) 286-1700
chad.sylvester@wustl.edu