NCT04911452

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

Recruiting now NA Last updated 1 January 2025

What this trial tests

NA trial testing Calmer in Prematurity in 30 participants. Currently enrolling.

Timeline

27 September 2021

Primary endpoint
30 June 2025

31 December 2025

Quick facts

Lead sponsor	University of British Columbia
Phase	NA
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	30
Start date	27 September 2021
Primary completion	30 June 2025
Estimated completion	31 December 2025
Sites	1 location across Canada

Drugs / interventions tested

• Calmer

Conditions studied

• Prematurity — all drugs for Prematurity →

Sponsor

University of British Columbia

Who can join

Adults 26 Weeks to 30 Weeks, any sex, with Prematurity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks).

Research questions:

Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT?

Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?

Publications & conference data

No peer-reviewed publications indexed yet for this trial.