What this Trial Is About

Researchers are studying preterm infants born between 26 and 30 weeks gestational age to evaluate a device called Calmer, designed to reduce stress and support brain development. Preterm babies often face stressful procedures in the neonatal intensive care unit (NICU), and untreated stress can affect brain growth. Calmer mimics skin-to-skin care by providing a soft surface with heartbeat sounds and breathing motions based on recordings from the infant's parents. The first trial showed Calmer lowered stress responses safely, and this pilot randomized controlled trial aims to test its use over 2-3 weeks to promote growth and brain development compared to standard NICU care. Infants will be randomized to either receive Calmer therapy or standard care. Those in the Calmer group will have the device for at least 3 hours daily during times when they cannot be held or parents are absent, with no upper time limit. The device settings are individualized daily using the infant's heart and breathing rates measured by nurses. Parents will be trained to provide their own heart and breathing rates to update settings if away from the NICU. The treatment period lasts a minimum of 2 weeks and up to 3 weeks. Participants will be closely monitored throughout the study, including assessments of physical growth such as weight gain, head circumference, and body length before and after the treatment period. Brain activity will be measured using EEG during resting and diaper change times. Researchers will track consent rates, protocol adherence, safety, and completeness of outcome data over 48 months to evaluate trial feasibility. The study will inform a larger future trial if the pilot goals are met.

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