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NCT05843396 · ClinicalTrials.gov registry record · NA
Brain Organization, Development, and Response to Intervention in Individual Neonates
A NA study of Development, Infant, sponsored by Washington University School of Medicine.
- Recruiting
- Registry status
- NA
- Development phase
- 80
- Enrollment target
- 2
- Study locations
NCT05843396: Recruiting NA study of Development, Infant, sponsored by Washington University School of Medicine.
NCT05843396 is a NA study of Development, Infant that is actively recruiting participants, run by Washington University School of Medicine. The registered enrollment target is 80 participants, below the 205-participant average among 3 other Development, Infant trials with a reported enrollment target (61% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05843396, a NA study of Development, Infant, is actively recruiting participants, sponsored by Washington University School of Medicine.
- RECRUITING
- Registry status
- NA
- Development phase
- 80 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- BEHAVIORAL Neonatal Massage
Study Locations (2)
Minnesota
- University of Minnesota - Minneapolis
Missouri
- Washington University School of Medicine - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2025-03-31 |
| Est. Completion | 2030-07 |
| Phase | NA |
What NCT05843396 shows while recruiting
NCT05843396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 205-participant average among 3 other Development, Infant trials with a reported enrollment target (61% lower).
The record links to 1 condition, with Development, Infant appearing as the primary indexed condition, and to 1 intervention - of which Neonatal Massage is the first listed.
NCT05843396 reports a single indexed study location in Minnesota, Missouri.
Frequently Asked Questions
What is clinical trial NCT05843396 about?
NCT05843396 is a clinical study titled "Brain Organization, Development, and Response to Intervention in Individual Neonates". 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.
What is the current status of trial NCT05843396?
This trial is currently recruiting. It is a NA study. The enrollment target is 80 participants. The study started on 2025-03-31. Estimated completion is 2030-07.
What conditions does trial NCT05843396 study?
This clinical trial studies the following conditions: Development, Infant.
What interventions are being tested in trial NCT05843396?
The interventions under investigation include: Neonatal Massage (BEHAVIORAL).
Who is sponsoring clinical trial NCT05843396?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05843396 being conducted?
This trial has 2 study locations across Minnesota, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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