Testing the Calmer Therapy Bed to Support Growth and Brain Development in Preterm Infants Born at 26 to 30 Weeks in the NICU

What this Trial Is About

Researchers are studying preterm infants born between 26 and 30 weeks gestational age who spend time in the neonatal intensive care unit NICU. The study evaluates whether using Calmer, a special therapy bed designed to mimic skin-to-skin care SSC by providing an artificial skin surface, heartbeat sounds, and breathing motion based on the parents recordings, can support better physical growth and brain development compared to standard NICU care. This pilot randomized controlled trial aims to test the feasibility and effects of using Calmer over 2 to 3 weeks in preterm infants. In the trial, 30 preterm infants will be randomly assigned to either receive standard NICU care or use the Calmer device placed in their incubator for a minimum total of 3 hours per day over 2 to 3 continuous weeks. Calmer use can be discontinuous and is intended for times when parents are unavailable or infants cannot be held. The device settings are customized daily based on each infants heart and breathing rates, which are recorded by nurses and parents. The study monitors infants during this treatment period to assess impact on growth and brain activity. Participants will be assessed before and after the treatment period, with measurements including daily weight gain, head circumference, body length, and brain electrical activity using EEG during rest and routine diaper changes. The study also tracks trial feasibility by monitoring consent rates, protocol adherence, data completeness, and safety over 48 months. Parents will be trained to help measure and communicate vital signs to support device programming. The total participation includes the 2 to 3 week treatment phase plus monitoring and follow-up.

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