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

NCT04911452 · University of British Columbia · Updated 1 Jan 2025

What is being tested
Calmer
For
Prematurity
Kind of study
Tests a treatment or device on volunteers. No drug phase (a device or procedure study).
Who can join
Ages 26 Weeks to 30 Weeks. About 30 people. The full rules are on the registry page.
Where
Canada
When
Starts or started 27 Sept 2021, ends 31 Dec 2025. Registered 3 June 2021.
Results
None posted yet.

In the researchers' words

Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff. The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test…
ClinicalTrials.gov, NCT04911452

Sites

  • British Columbia Women's Hospital and Health CentreVancouver, British Columbia, Canada