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NCT05843396 Clinical Trial

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

Development, Infant Clinical Trial

Official title:
Brain Organization, Development, and Response to Intervention in Individual Neonates

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05843396
Other study ID # 1368060
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date March 2024
Est. completion date May 2030

Study information
Verified date April 2023
Source Washington University School of Medicine
Contact Chad Sylvester, MD/PhD
Phone (314) 286-1700
Email chad.sylvester@wustl.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 80
Est. completion date May 2030
Est. primary completion date March 2029
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group N/A and older
Eligibility 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 - Non-singleton pregnancy (e.g., twins) - Gestational Age <36 weeks (neonates) - Neonatal encephalopathy (neonates)

Study Design

Related Conditions & MeSH terms

Intervention

Behavioral:
• Neonatal Massage
caregivers providing therapeutic touch techniques on their neonate

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Washington University School of Medicine University of Minnesota

Outcome
Type Measure Description Time frame Safety issue
Primary changes in functional connectivity in the neonatal brain up to 3 months
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