Actively Recruiting

Phase Not Applicable
Age: 26Weeks - 30Weeks
All Genders
ID04911452

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

Led by University of British Columbia · Updated on 2025-01-01

30

Participants Needed

1

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

University of British Columbia

Lead Sponsor

W

Women's Health Research Institute of British Columbia

Collaborating Sponsor

AI-Summary

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 infant's 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.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 26Weeks - 30Weeks
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Preterm infants born at 26-30 completed weeks gestational age admitted to the NICU at BC Women's Hospital
  • Infants receiving continuous positive airway pressure or ventilation
  • At least one parent or caregiver must speak sufficient English to provide consent
Not Eligible

You will not qualify if you...

  • Infants with congenital anomalies or small for gestational age
  • Infants with ongoing infection at enrollment
  • Infants with pre-existing cardiovascular instability such as shock, hypotension, or need for cardiovascular drugs
  • Infants receiving paralytic drugs
  • Infants with major neurological injury including hypoxic ischemic encephalopathy or stroke
  • Infants older than 30 weeks and 6 days gestational age at enrollment

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Implementation

Duration - 2 to 3 weeks

Participants in the Calmer group will have the Calmer device placed and left in the infant incubator for a minimum of 2 and maximum of 3 weeks. Calmer treatment is provided for a minimum total of 3 hours per day, which may be discontinuous. The research and bedside nurses record infant heart and respiratory rates daily to program the device. Parents are trained to self-measure resting heart and breathing rates for remote updates if needed.

Daily interactions with research and bedside nurses during hospital stay

Trial Site Locations

Total: 1 location

1

British Columbia Women's Hospital and Health Centre

Vancouver, British Columbia, Canada, V6H 3N1

Actively Recruiting

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Research Team

M

Manon Ranger, PhD

L

Lindsay Richter, MSc

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial.

Manon Ranger, Arianne Albert, Karon MacLean...

https://pubmed.ncbi.nlm.nih.gov/33490850