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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: manon.ranger@ubc.ca
• Phone: 1-604-827-1382

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.