Calmer Brains in Very Preterm Infants

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.

NCT Number	NCT07262385
Lead Sponsor	University of British Columbia Collaborators: BC Children's Hospital Research Institute
Conditions	Premature Infant
Enrollment	20 participants
Start Date	2025-12-01
Primary Completion	2027-04 (estimated)
Study Completion	2027-09 (estimated)
Updated on ClinicalTrials.gov	2025-12-03