Clinical Research Directory
Browse clinical research sites, groups, and studies.
Calmer Brains in Very Preterm Infants
Sponsor: University of British Columbia
Summary
Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.
Official title: Calmer Brains: A Pilot Randomized Trial to Explore Structural and Functional Brain Development in Preterm Infants
Key Details
Gender
All
Age Range
26 Weeks - 30 Weeks
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2025-12-01
Completion Date
2027-09
Last Updated
2025-12-03
Healthy Volunteers
No
Conditions
Interventions
Calmer
Calmer, a unique, patented, therapeutic bed that mimics key aspects of SSC that reduce stress in preterm infants. Calmer fits into NICU incubators and cribs, and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds; the rates of the latter 2 stimuli are individualized to each infant based on their parents' breathing and heart rates. Calmer is designed to provide complementary care only when parents are not able to give SSC. It is not meant nor designed to replace human SSC, so will never be tested as such a replacement. Instead, Calmer was invented to enhance and optimize brain development in preterm infants by reducing stress during the NICU stay, when parents/caregivers are not available for SSC. Our ultimate goal is to enable use of Calmer from an infant's admission to discharge, only during those times when caregivers are not available.
Locations (1)
BC Women's Hospital & Health Centre
Vancouver, British Columbia, Canada