Recruiting NCT05843396
Brain Organization, Development, and Response to Intervention in Individual Neonates
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Neonatal Massage.
- Who it may be relevant to
- Registry conditions: Development, Infant. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral Neonatal Massage
caregivers providing therapeutic touch techniques on their neonate
Primary outcome measures
- Change in correlated brain activity among functional brain areas in the somatomotor cortex [Time frame: up to 3 months]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- University of Minnesota — Minneapolis
- Washington University School of Medicine — St Louis
Identifiers
NCT: NCT05843396 · 202404186