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

Trial Summary

What is the purpose of this trial?

Infants born preterm can spend months in the neonatal intensive care unit (NICU) where they experience stressful but essential procedures. Untreated stress is associated with altered brain development. Skin-to-skin care (SSC) is one of the most effective behavioral strategies for mitigating preterm infant stress and improving brain maturation. However, parents may not be always available to provide SSC; some infants cannot be held for long periods for medical reasons. To address this problem, investigators designed Calmer, a patented, prototype therapy bed, for reducing stress in preterm infants. Calmer fits into NICU incubators and provides simultaneously an artificial skin surface, heartbeat sounds and breathing motion, mimicking aspects of SSC; the latter 2 features are individualized for each infant based on their parents' recordings. The 1st randomized controlled trial (RCT) in 58 preterm babies showed that during a routine blood test: Calmer lowered infant behavioral and heart stress responses and stabilized brain blood flow no differently than facilitated tucking; infants could be cared for safely on Calmer up to 6 hours in 1 day; Calmer was well accepted by mothers and staff. The goal now is to determine the efficacy of Calmer use over 3 weeks to support optimal physical growth and brain development in preterm infants. A 2-group (treatment, control) pilot RCT to test the implementation of an increased "dose" of Calmer exposure over 2-3 continuous weeks is proposed. 30 infants born between 26-30 weeks gestational age in the NICU will be randomized to receive either Calmer, for a minimum of 3 hours in total/day for 2-3 continuous weeks, or to 2-3 weeks of standard NICU care (minimum of 2 and maximum of 3 weeks). Research questions: Trial feasibility Q1. Is it feasible to enrol 30 infants, complete a 2-3-week treatment period (minimum of 2 and maximum of 3 weeks), and measure growth outcomes in preterm infants (26-30 weeks GA) in the NICU in a pilot RCT of daily Calmer treatment versus standard NICU care to inform a larger, definitive RCT? Infant outcomes Q2a. Are there differences in physical growth markers (daily weight gain, head circumference, body length) between preterm infants who receive Calmer and those who receive standard NICU care measured before (baseline) and after 2-3 weeks of daily Calmer exposure? Q2b. Are there differences in brain activity markers, as measured by cerebral electrical (EEG) signalling, between preterm infants who receive Calmer and those who receive standard NICU care, measured during a resting/sleeping state and routine diaper change session at the end of the trial (post 2-3 weeks of daily Calmer exposure)?

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 data supports the effectiveness of the treatment Calmer for premature infants?

The Calmer device, which mimics skin-to-skin holding, was shown to reduce stress in preterm infants by 50% compared to no treatment, and it performed similarly to the standard care method of facilitated tucking for reducing pain during procedures. ^{1 2 3 4 5}

Is the Calmer Therapy Bed safe for use in premature infants?

Research on the Calmer device, which mimics skin-to-skin contact to reduce stress and pain in preterm infants, shows it is safe and effective in reducing pain and stress without any reported adverse effects. ^{1 3 6 7 8}

How is the Calmer therapy bed different from other treatments for premature infants?

The Calmer therapy bed is unique because it uses a robot to reduce pain in premature infants by increasing parasympathetic activation (a part of the nervous system that helps calm the body) during stressful procedures like blood collection, which is different from other treatments like waterbeds or massage that focus on improving sleep and reducing irritability. ^{1 6 9 10 11}

Research Team

Liisa Holsti, PhD

Principal Investigator

The University of British Columbia

Manon Ranger, PhD

Principal Investigator

The University of British Columbia

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sleep enhanced and irritability reduced in preterm infants: differential efficacy of three types of waterbeds. [2007]

2. United States pubmed.ncbi.nlm.nih.gov

A modified newborn intensive care unit environment may shorten hospital stay. [2006]

3. United States 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. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Feasibility and Impact of a Pilot Neonatal Cuddler Program on Preterm Infants in the Neonatal Intensive Care Unit. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Sleep patterns and psychosocial health of parents of preterm and full-born infants: a prospective, comparative, longitudinal feasibility study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Pilot Testing a Robot for Reducing Pain in Hospitalized Preterm Infants. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Calmer: a robot for managing acute pain effectively in preterm infants in the neonatal intensive care unit. [2022]

8. United States 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. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Conformational positioning improves sleep in premature infants with feeding difficulties. [2014]

10. Brazil pubmed.ncbi.nlm.nih.gov

[Effect of reducing sensory and environmental stimuli during hospitalized premature infant sleep]. [2016]

11. England pubmed.ncbi.nlm.nih.gov

Effect of massage on behavioural responses of preterm infants in an educational hospital in Iran. [2020]