Calmer for Premature Infants
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device called Calmer, designed to mimic parental holding and reduce stress in very premature infants in the NICU. Researchers aim to determine if Calmer can improve brain development compared to standard NICU care by using specialized brain scans. Infants in the trial will receive Calmer therapy for at least 3 hours daily over 2-3 weeks. The trial seeks very preterm infants in the NICU who do not have certain medical conditions, such as infections or major neurological injuries. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that may enhance care for future NICU infants.
Will I have to stop taking my current medications?
The trial information does not specify whether participants need to stop taking their current medications.
What prior data suggests that the Calmer device is safe for premature infants?
Studies have shown that Calmer, a special bed for premature babies, is safe. Research indicates that babies using Calmer maintain normal brain oxygen levels, similar to those held by people. This confirms the device's safety and lack of harm. Another study found that Calmer reduces pain in premature babies without adverse side effects. Overall, evidence shows that Calmer is safe and well-tolerated for very premature infants.12345
Why are researchers excited about this trial?
Calmer is unique because it delivers therapeutic benefits by simulating key aspects of skin-to-skin care (SSC), like touch, breathing motion, and heartbeat sounds, all tailored to each infant's needs. Unlike standard NICU care, which often relies on direct parental SSC, Calmer fits into the incubator, providing continuous support even when parents can't be present. Researchers are excited because this approach could reduce stress in premature infants more consistently and effectively, potentially improving developmental outcomes.
What evidence suggests that the Calmer device is effective for reducing stress in premature infants?
Research has shown that Calmer, a special bed for babies, can reduce stress in premature infants. It mimics skin-to-skin care by providing gentle touch, breathing-like movement, and heartbeat sounds. In this trial, infants in the Calmer group will receive these benefits, while those in the Control group will receive standard NICU care, including parent skin-to-skin care. Studies have found that Calmer can lower signs of pain and stress in babies, such as a fast heartbeat. It also helps maintain steady blood flow to the brain during stressful times, like blood tests. This suggests that Calmer might aid brain development by reducing stress in the NICU. Overall, Calmer offers promising results similar to the benefits of human touch.13567
Who Is on the Research Team?
Manon Ranger, PhD
Principal Investigator
University of British Columbia
Liisa Holsti, PhD
Principal Investigator
University of British Columbia
Are You a Good Fit for This Trial?
This trial is for very preterm infants born 3-4 months early, currently in the NICU. It's designed to help those who cannot be held by their parents often due to medical reasons. The study aims to include a small group of these infants without specifying further inclusion or exclusion criteria.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Infants receive Calmer treatment for 2-3 continuous weeks, 3 hours/day minimum
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Calmer
Trial Overview
The 'Calmer' device is being tested for its ability to mimic parental holding and reduce stress in premature infants. The study compares brain development between infants receiving Calmer plus regular care and those with just regular NICU care, using brain scans at full term.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Infants in the Calmer group will have a Calmer\* placed and left in their incubators for a minimum of 2 and maximum of 3 weeks and will receive treatment for a minimum cumulative total of 3 hours/day (i.e. time can be discontinuous). Each day, after the infant's parent rests for 10 minutes, the research and/or bedside nurse will record the heart and respiratory rates for a 2-minute period (or taken by the caregiver themselves after training by research/NICU staff). The 1-minute average will be used to program Calmer for each infant that day to better simulate day-to-day changes in infant-parent contact. The values can be adjusted over the day as parents wish. \*Calmer, a patented, therapeutic bed that mimics key aspects of skin-to-skin care (SSC) to reduce stress in preterm infants. Calmer fits into NICU incubators and delivers 3 key SSC stimuli: touch, breathing motion, and heartbeat sounds (rates individualized to each infant based on their parents' HR/RR).
Infants in the Control group will receive standard NICU care, including parent SSC.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
BC Children's Hospital Research Institute
Collaborator
Citations
Calmer: a robot for managing acute pain effectively in ...
Calmer reduced biobehavioral pain indices in preterm infants no differently from a human touch–based intervention. Calmer shows promise as an adjunctive ...
NCT07262385 | Calmer Brains in Very Preterm Infants
Calmer, a unique, patented, therapeutic bed that mimics key aspects of SSC that reduce stress in preterm infants. Calmer fits into NICU ...
Parental and nursing perspectives of a therapeutic device
Calmer has been shown to significantly reduce infant pain behaviours, heart rate stress responses, and stabilize brain blood flow during a single blood test ( ...
4.
journals.lww.com
journals.lww.com/painrpts/fulltext/2021/01000/cerebral_hemodynamic_response_to_a_therapeutic_bed.3.aspxCerebral hemodynamic response to a therapeutic bed for...
Our feasibility trial showed that Calmer worked 50% better than no treatment and no differently from our standard of care, facilitated tucking (FT), for ...
5.
cs.ubc.ca
cs.ubc.ca/labs/spin/sites/default/files/local_pdfs/CalmerNIRS_PAINreports_2021-appeared_0.pdfa randomized c - UBC Computer Science
Conclusions: Infants on Calmer maintained normal regional cerebral oxygen levels (55%–85%) no differently from infants receiving a human touch ...
NCT07262385 | Calmer Brains in Very Preterm Infants
*Calmer, a patented, therapeutic bed that mimics key aspects of skin-to-skin care (SSC) to reduce stress in preterm infants. Calmer fits into ...
Cerebral hemodynamic response to a therapeutic bed for ...
Preterm infants on Calmer maintained normal regional cerebral oxygen levels (55%–85%) no differently from infants receiving a human touch intervention ...
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