Creating a Calmer NICU: Optimizing Growth and Brain Development in Preterm Infants

NARecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 27, 2021

Primary Completion Date

June 30, 2025

Study Completion Date

December 31, 2025

Conditions
Prematurity
Interventions
DEVICE

Calmer

Once randomized, infants in the Calmer group will receive treatment for a minimum cumulative total of 3 hours/day during periods when the infant may be too ill to be held or when parents do not wish to hold their infant or are not present. Calmer does not replicate a parent's contact and so the minimum exposure has been tripled. No upper limit of Calmer use will be set. Each day, the research and/or bedside nurse will record the heart and respiratory rates for a two-minute period. The one-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The Neonatal Intensive Care Unit (NICU) research nurse will also train the parents/caregivers to self-measure their resting heart and breathing rates so that if they are away from the NICU for more than one day, these values can be sent to the research/ bedside nurse by phone.

Trial Locations (1)

V6H 3N1

RECRUITING

British Columbia Women's Hospital and Health Centre, Vancouver

All Listed Sponsors
collaborator

Women's Health Research Institute of British Columbia

OTHER

lead

University of British Columbia

OTHER