Brain Organization, Development, and Response to Intervention in Individual Neonates
Sponsor
Washington University School of Medicine (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05843396
Collaborator
University of Minnesota (Other)
80
2
74
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Basic Science
Official Title:
Brain Organization, Development, and Response to Intervention in Individual Neonates
Anticipated Study Start Date
:
Mar 1, 2024
Anticipated Primary Completion Date
:
Mar 1, 2029
Anticipated Study Completion Date
:
May 1, 2030
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Neonatal Massage Received
|
Behavioral: Neonatal Massage
caregivers providing therapeutic touch techniques on their neonate
|
| No Intervention: No Massage Received
|
Outcome Measures
Primary Outcome Measures
- changes in functional connectivity in the neonatal brain [up to 3 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
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
-
Non-singleton pregnancy (e.g., twins)
-
Gestational Age <36 weeks (neonates)
-
Neonatal encephalopathy (neonates)
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Washington University School of Medicine
- University of Minnesota
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05843396
Other Study ID Numbers:
- 1368060
First Posted:
May 6, 2023
Last Update Posted:
May 6, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No