Clinical Trials Logo
  1. Home
  2. Development, Infant
  3. NCT05843396
  4. Details
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
See also
  Status Clinical Trial Phase
Recruiting NCT05412524 - Impact of Reading on Endogenous Oxytocin System of Preterm Infants N/A
Active, not recruiting NCT03506971 - Early Childhood : Action Research in the Lunévillois Area (PERL) N/A
Completed NCT04301453 - The Effect of Maternal Scent on Sleep Wake States N/A
Terminated NCT04436055 - Intergenerational Effects of Paternal Periconceptional Cannabis and Other Drug Use (EPIC)
Recruiting NCT05527080 - Development of Motility and Cognition in Infants
Not yet recruiting NCT06396520 - Neuroimaging of Babies During Natural Sleep to Assess Typical Development and Cerebral Palsy
Recruiting NCT05230199 - Sensory Optimization of the Hospital Environment N/A
Recruiting NCT03849248 - Maternal Scent and Preterm Infant Nutrition N/A
Not yet recruiting NCT05901766 - Effect of Iodine-containing Multiple Micronutrient During Lactation on Infant Neurodevelopment Phase 4
Recruiting NCT05834907 - Hands and Hearts Together N/A
Not yet recruiting NCT06157697 - Social Transfers for Exclusive Breastfeeding in Brazil N/A
Completed NCT05261503 - Investigation of the Effectiveness of Environmental Enrichment-Based Intervention in Preterm Infants N/A
Completed NCT04506541 - The Effects Of KC On Exclusively Breastfeeding And Baby's Growth And Development According To Attachment Theory N/A
Completed NCT05778357 - The Effect of the Covid 19 Pandemic Process on the Neuromotor Developments of 6-24 Month-old Babies
Active, not recruiting NCT05404815 - Exposure to Plasticisers in the Neonatal Intensive Care Unit
Not yet recruiting NCT06377098 - Intrapartum Sildenafil in Laboring Mothers Phase 2
Completed NCT04203589 - Explorer Babies Early Intervention Program N/A
Completed NCT03306316 - Prebiotic in Preterm Infants N/A
Completed NCT05147480 - Online Mother-Baby Yoga With Preterm Infants and Their Mothers N/A
Recruiting NCT04689386 - Effect of Chest Physiotherapy on the Development of Preterm Infants. N/A