Calmer Therapy Bed for Premature Infants

Overseen By Lindsay Richter, MSc

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Paralytics

Disqualifiers: Congenital anomalies, Infection, Cardiovascular instability, Neurological injury, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 2-3 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the Calmer therapy bed to determine if it aids premature infants' growth and development in the NICU. Calmer mimics skin-to-skin contact by providing a soothing surface, heartbeat sounds, and breathing motions tailored to each baby using their parents' recordings. The trial will compare the growth and brain activity of babies using Calmer for a few hours daily over 2-3 weeks with those receiving regular NICU care. Eligible participants are preterm infants born at 26-30 weeks who are on breathing support and have at least one English-speaking parent for consent. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve care for premature infants.

Will I have to stop taking my current medications?

The trial information does not specify whether participants must stop taking their current medications. It focuses on preterm infants in the NICU and does not mention any medication changes.

What prior data suggests that the Calmer therapy bed is safe for preterm infants?

Research has shown that the Calmer therapy bed is safe for premature babies. In a study with 58 preterm infants, Calmer reduced stress and maintained steady brain blood flow, similar to the usual care method known as facilitated tucking. Babies safely used Calmer for up to 6 hours a day.

Another study found that babies using Calmer maintained normal oxygen levels in their brains, comparable to those who received human touch. This indicates that Calmer does not harm critical functions like brain oxygen levels.

These findings suggest that Calmer is well-tolerated and does not harm babies. Both parents and hospital staff felt comfortable using Calmer, which supports its safety in hospitals. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Calmer therapy bed for premature infants is unique because it offers a gentle, non-invasive way to support the development of preemies in a neonatal intensive care unit (NICU) setting. Unlike traditional incubator care, which primarily focuses on maintaining a stable environment, Calmer provides targeted therapy directly within the incubator for at least 3 hours a day. Researchers are excited about this approach because it could enhance the sensory environment for premature infants, potentially promoting better growth and neurological development during those critical early weeks.

What evidence suggests that the Calmer therapy bed is effective for reducing stress in preterm infants?

In this trial, some participants will receive the Calmer therapy, which previous studies have shown to reduce stress in premature babies during routine procedures. It stabilized their heart rates and ensured normal blood flow to the brain, similar to the benefits of human touch. Calmer mimics skin-to-skin care by providing a gentle heartbeat sound and breathing motion customized for each baby. Premature babies using Calmer maintained normal oxygen levels in their brains, crucial for healthy brain development. While more research is needed to understand the long-term effects, early findings suggest that Calmer could support growth and brain development in premature babies. ^{1 2 3 4 5}

Who Is on the Research Team?

Liisa Holsti, PhD

Principal Investigator

The University of British Columbia

Manon Ranger, PhD

Principal Investigator

The University of British Columbia

Are You a Good Fit for This Trial?

This trial is for preterm infants in the NICU at BC Women's Hospital, born between 26-30 weeks gestational age. They can be on airway support but must not have major health issues like congenital anomalies, infections at enrolment, neurological injuries, cardiovascular instability or a history of maternal substance abuse.

Inclusion Criteria

My preterm baby was admitted to NICU at BC Women's Hospital, born at 26-30 weeks.

Infants who are on continuous positive airway pressure or are ventilated

My parent or caregiver can speak enough English to give consent.

Exclusion Criteria

My infant has had a serious brain injury like lack of oxygen, bleeding, or stroke.

My baby was born small, has birth defects, or was exposed to drugs in the womb.

My baby was born after 30 weeks of pregnancy.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Infants receive either Calmer therapy or standard NICU care for 2-3 weeks

2-3 weeks

Daily monitoring in NICU

Follow-up

Participants are monitored for growth and brain development outcomes after treatment

4 weeks

Extension

Potential continuation of monitoring for long-term outcomes in a larger RCT

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Calmer

Trial Overview The study tests Calmer—a therapy bed designed to reduce stress and promote growth in preterm babies by mimicking skin-to-skin contact with artificial touch, heartbeat sounds and breathing motion. The trial compares daily use of Calmer for three weeks against standard NICU care to see if it improves physical growth and brain oxygen signaling.

How Is the Trial Designed?

Group I: Calmer Experimental Treatment 1 Intervention

Calmer placed and left in infant incubator for a minimum of 2 and maximum of 3 weeks. Calmer treatment provided for minimum total of 3 hours/day (can be discontinuous).

Group II: Control Active Control 1 Intervention

Standard Neonatal Intensive Care Unit (NICU) care

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Women's Health Research Institute of British Columbia

Collaborator

Trials

8

Recruited

16,600+

Published Research Related to This Trial

The study evaluated the feasibility of a longitudinal study on sleep patterns and psychosocial health in parents of preterm and full-born infants, successfully recruiting 78 parents of full-born infants but facing challenges with only 25 parents of preterm infants.

Despite the feasibility of using actigraphs and sleep diaries for data collection, high attrition rates were noted, particularly at 6 and 12 months, indicating a need for improved recruitment strategies for parents of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep patterns and psychosocial health of parents of preterm and full-born infants: a prospective, comparative, longitudinal feasibility study. Marthinsen, GN., Helseth, S., Småstuen, M., et al.[2022]

In a study of 13 premature infants, reducing sensory and environmental stimuli in the neonatal unit significantly increased their total sleep time, with infants averaging 696.4 minutes of sleep without management compared to 168.5 minutes with management.

The results showed that infants slept about 70.2% of the time during periods without intervention, compared to only 58.0% during periods with environmental management, indicating that a calmer environment is beneficial for premature infants' sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of reducing sensory and environmental stimuli during hospitalized premature infant sleep]. Orsi, KC., Llaguno, NS., Avelar, AF., et al.[2016]

A study involving 49 preterm infants tested the Calmer robotic device, which simulates skin-to-skin contact, to see if it could reduce pain during a blood test.

The results showed that Calmer was as effective as human touch-based treatment (facilitated tucking) in mitigating pain, but further research is needed to explore its long-term effects on stress reduction in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit. Holsti, L., MacLean, K., Oberlander, T., et al.[2022]

The study found that using a conformational positioner improved sleep efficiency in premature infants, achieving 61% efficiency compared to 54% on a standard mattress, based on a trial involving 25 infants.

The benefits of the conformational positioner were particularly notable in infants with surgical needs or gastrointestinal issues, suggesting that these infants may experience more environmental stress affecting their sleep.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Conformational positioning improves sleep in premature infants with feeding difficulties. Visscher, MO., Lacina, L., Casper, T., et al.[2014]

Premature infants placed in a microprocessor-controlled cradle that mimicked the intrauterine environment had a significantly shorter hospital stay compared to those in standard care, indicating enhanced recovery.

The experimental group also showed earlier feeding milestones and a reduced incidence of apnea, suggesting that appropriate sensory stimulation can positively influence the maturation of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A modified newborn intensive care unit environment may shorten hospital stay. Gatts, JD., Wallace, DH., Glasscock, GF., et al.[2006]

A neonatal cuddler program (NCP) significantly improved growth parameters in preterm infants, as those who interacted with volunteers weighed more and had higher occipitofrontal circumferences at discharge compared to the control group.

Despite some increased risks of certain complications, the NCP provided positive sensory experiences that benefited the infants' growth, highlighting the importance of such programs in the NICU setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and Impact of a Pilot Neonatal Cuddler Program on Preterm Infants in the Neonatal Intensive Care Unit. Bushroe, K., Lloyd, B., McDaneld, C., et al.[2022]

In a study involving 45 preterm infants in a neonatal intensive care unit, daily 15-minute massages over 5 days significantly improved sleep state scores and reduced fidgeting and motor activity, indicating a calming effect.

While the massage did not significantly change overall behavioral distress, the results suggest that massage could be a beneficial nursing intervention for soothing preterm infants, highlighting the need for proper training for nurses in this technique.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of massage on behavioural responses of preterm infants in an educational hospital in Iran. Baniasadi, H., Hosseini, SS., Abdollahyar, A., et al.[2020]

The Calmer device, designed to mimic skin-to-skin holding, was found to be 50% more effective than no treatment in reducing pain during heel lances in preterm infants, showing promise as an alternative to standard care.

In a study of 29 preterm infants, Calmer maintained normal cerebral oxygen levels during painful procedures, similar to the effects of facilitated tucking, suggesting it could be a beneficial option when parental holding is not available.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cerebral hemodynamic response to a therapeutic bed for procedural pain management in preterm infants in the NICU: a randomized controlled trial. Ranger, M., Albert, A., MacLean, K., et al.[2022]

A new NICU-focused trigger tool was developed and tested, revealing a high incidence of adverse events in hospitalized children, with 554 unique adverse events identified across 749 charts, averaging 0.74 events per patient.

The study found that 56% of these adverse events were preventable, highlighting the need for improved safety measures, as only 8% were reported through traditional hospital reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in the neonatal intensive care unit: development, testing, and findings of an NICU-focused trigger tool to identify harm in North American NICUs. Sharek, PJ., Horbar, JD., Mason, W., et al.[2021]

In a pilot trial with 10 preterm infants, the Calmer robot significantly increased parasympathetic activation, indicating reduced stress and pain during routine blood collection compared to standard care.

Calmer infants showed 90% greater parasympathetic activation at baseline and maintained higher levels during the painful procedure, suggesting it effectively mitigates pain reactivity in preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Testing a Robot for Reducing Pain in Hospitalized Preterm Infants. Williams, N., MacLean, K., Guan, L., et al.[2022]

A study involving 52 stable preterm infants found that using waterbeds significantly improved sleep quality and reduced irritability compared to a control group on standard incubator mattresses.

Among the different types of waterbeds tested, continuously oscillating waterbeds were the most effective in decreasing irritability and restlessness, suggesting that waterbeds can be a beneficial and cost-effective option for enhancing the care of preterm infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sleep enhanced and irritability reduced in preterm infants: differential efficacy of three types of waterbeds. Korner, AF., Lane, NM., Berry, KL., et al.[2007]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6455690/

Calmer: a robot for managing acute pain effectively in ... The purpose of this randomized controlled trial was to evaluate the efficacy of Calmer to reduce biobehavioral acute pain indices in stable preterm infants in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04911452

Creating a Calmer NICU: Optimizing Growth and Brain ... The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress ...

3. journals.lww.com journals.lww.com/painrpts/fulltext/2021/01000/cerebral_hemodynamic_response_to_a_therapeutic_bed.3.aspx

Cerebral hemodynamic response to a therapeutic bed for... Conclusions: Infants on Calmer maintained normal regional cerebral oxygen levels (55%–85%) no differently from infants receiving a human touch intervention ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7808560/

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 ...

5. researchgate.net researchgate.net/publication/332008738_Calmer_a_robot_for_managing_acute_pain_effectively_in_preterm_infants_in_the_neonatal_intensive_care_unit

(PDF) Calmer: a robot for managing acute pain effectively ... More research is needed to determine effects of Calmer for stress reduction in preterm infants in the neonatal intensive care unit over longer periods. ...