Calmer for Premature Infants

Overseen By Manon Ranger, PhD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

Very preterm infants in the neonatal intensive care unit (NICU) need lifesaving medical procedures which can be stressful and affect brain development. Calmer was invented to mimic key parts of parental holding (touch, heartbeat sounds and breathing motion) to help reduce stress if parents cannot be there to hold their infant. Using specialized brain scans done at full term, we will gather initial information in 22 infants born 3-4 months early to compare brain development in infants who receive Calmer at least 3 hours each day (+ regular NICU care) over 2-3 weeks with infants who have regular NICU care.

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

Very preterm infants admitted to the NICU at the BC Women's Hospital

Exclusion Criteria

Infants with congenital anomalies

Infants with a history of birthing parent substance use in pregnancy

Infants with ongoing infection at the time of enrollment

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?

Group I: Calmer Experimental Treatment 1 Intervention

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).

Group II: Control Active Control 1 Intervention

Infants in the Control group will receive standard NICU care, including parent SSC.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

BC Children's Hospital Research Institute

Collaborator

Trials

14

Recruited

2,800+