Examining the effects of massage on newborn brain development
Brain Organization, Development, and Response to Intervention in Individual Neonates
This study is testing whether daily massages can help improve brain development in newborns compared to those who don’t receive massages.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 2 sites (Minneapolis, Minnesota and 1 other locations) |
| Trial ID | NCT05843396 on ClinicalTrials.gov |
What this trial studies
This study aims to investigate the impact of daily massage on brain connectivity in neonates shortly after birth. Participants will be divided into two groups, with one group receiving daily massages while the other will not, allowing researchers to observe any differences in brain development and response to intervention. The study focuses on understanding how early interventions may influence infant brain organization and development. By analyzing the outcomes, the researchers hope to gain insights into effective strategies for enhancing neonatal care.
Who should consider this trial
Good fit: Ideal candidates for this study are English-speaking parents of healthy neonates born at or after 36 weeks of gestation.
Not a fit: Patients who may not benefit from this study include those with neonatal encephalopathy or those born prematurely before 36 weeks of gestation.
Why it matters
Potential benefit: If successful, this study could lead to improved developmental outcomes for infants through early interventions like massage.
How similar studies have performed: While the specific approach of neonatal massage is less commonly studied, similar interventions in early childhood development have shown promising results in enhancing infant outcomes.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Minneapolis, Minnesota and 1 other locations
- University of Minnesota — Minneapolis, Minnesota, United States (Recruiting)
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Study coordinator: Chad Sylvester, MD/PhD
- Email: chad.sylvester@wustl.edu
- Phone: (314) 286-1700
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.