Optimizing growth and brain development in preterm infants using a robotic device

Creating a CALMER NICU: Pilot Testing a Robot for Optimizing Growth and Brain Development in Preterm Infants in the NICU

This study is testing a special therapy bed called Calmer to see if it helps reduce stress and improve growth and brain development in preterm babies in the NICU.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 26 Weeks to 30 Weeks
• Sex: All
• Sponsor: University of British Columbia (other)
• Locations: 1 site (Vancouver, British Columbia)
• Trial ID: NCT04911452 on ClinicalTrials.gov

What this trial studies

This pilot trial aims to assess the effectiveness of a prototype therapy bed called Calmer, designed to reduce stress in preterm infants in the neonatal intensive care unit (NICU). The device mimics skin-to-skin care by providing an artificial skin surface, heartbeat sounds, and breathing motion, personalized with recordings from the parents. The study will enroll preterm infants born at 26-30 weeks gestational age and will evaluate the feasibility of implementing this intervention, including patient accrual and adherence to treatment protocols. If successful, the results will inform a larger randomized controlled trial comparing the combined approach of skin-to-skin care and Calmer against skin-to-skin care alone.

Who should consider this trial

Good fit: Ideal candidates for this study are preterm infants born at 26-30 weeks gestational age who are admitted to the NICU and require respiratory support.

Not a fit: Patients with congenital anomalies, major neurological injuries, or ongoing infections may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve brain development and reduce stress in preterm infants, leading to better long-term outcomes.

How similar studies have performed: Previous studies have shown promising results with similar approaches to reducing stress in preterm infants, indicating potential for success in this novel intervention.

Eligibility criteria

Inclusion Criteria:

* Preterm infants admitted to the neonatal intensive care unit (NICU) at the British Columbia (BC) Women's Hospital born at 26-30 completed weeks gestational age (GA). GA is determined accurately using early gestation ultrasonogram (standard of care in BC), or calculated using the last menstrual period;
* Infants who are on continuous positive airway pressure or are ventilated;
* At least one parent/caregiver must speak sufficient English to provide consent

Exclusion Criteria:

* Infants who have congenital anomalies, small for GA (per medical admission history), or have a history of maternal abuse of controlled drugs and substances; - Infants with an ongoing infection at the time of enrolment;
* Infants that have pre-existing cardiovascular instability defined by shock/hypotension/need for cardiovascular drugs
* Infants receiving paralytic drugs;
* Infants that have major neurological injury (e.g. hypoxic ischemic encephalopathy, hemorrhage/stroke);
* Infants who are beyond the 30th completed week GA (30 weeks + 6 days) at enrolment.

Where this trial is running

Vancouver, British Columbia

• British Columbia Women's Hospital and Health Centre — Vancouver, British Columbia, Canada (RECRUITING)

Study contacts

• Principal investigator: Liisa Holsti, PhD — The University of British Columbia
• Study coordinator: Manon Ranger, PhD

Conditions: Prematurity, Neonatal intensive care, Growth, Robotic device, Skin-to-skin care, Stress, Brain activity, EEG