The Calmer Project

Study Overview
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Brief Summary
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The purpose of this study is to see if the Calmer is more effective at managing acute pain in preterm infants in the neonatal intensive care than the current standard of care in the unit. Hypothesis: While receiving treatment with Calmer, infants will show lower behavioral pain scores and lower heart rates, and more stable autonomic regulation as measured by heart rate variability indices, than infants given a soother plus facilitated tucking (standard of care) during routine blood collection.

Detailed Description
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60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.

Official Title
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Calmer: A Novel Approach for Treating Infant Pain

Conditions
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Acute Pain

Intervention / Treatment
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* Device: The Calmer
* Other: Standard of Care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Stable infants admitted to the Neonatal Intensive Care Unit at Children's and Women's Health Centre of British Columbia (C&W) Preterm infants born at 27 to 36+6 completed weeks gestational age (GA) will be included GA is determined on the basis of the first day of the last menstrual period, early gestation ultrasonogram (in most cases) or best estimate based on neonatal examination Mothers must speak enough English to provide consent Exclusion Criteria: Infants who have congenital anomalies, active, ongoing infection, or have undergone surgery Infants who have received pharmacological analgesics or sedatives within 72 hours of the assessment History of maternal abuse of controlled drugs and substances; blood collection that occurs beyond the 35th completed week (35 weeks + 6 days) GA Small for GA defined as a birth weight at least 2 standard deviations below mean for GA Higher order multiples (e.g. triplets) Infants in a cot

Ages Eligible for Study
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Minimum Age: 27 Weeks
Maximum Age: 36 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calmer<br>This therapeutic platform, called the Calmer interacts with the infant to help reduce stress to help promote better outcomes. It is being tested to see if it mimics Kangaroo care, maternal skin to skin, to help promote better health outcomes. Infants would be placed on it prior, during and after bloodwork to see if it elicits a favorable response. | Device: The Calmer<br>* This platform, called the Calmer, interacts with the infant to help reduce stress to help promote better outcomes. Infants can be placed on it for care to mimic Kangaroo Care, maternal skin to skin.<br>|
| Placebo Comparator: Standard Care<br>Standard of care during bloodwork is receiving a soother and facilitated tucking. | Other: Standard of Care<br>* Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Behavioral Indicators of Infant Pain (BIIP) Score | The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants. | During the assessment period in the study, estimated to occur around one hour. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Outcome Measures: Heart Rate | Heart rate will be recorded during the assessment period, one hour, to denote changes. Additionally, the heart rate will be recorded after the assessment period, for approximately 5 hours. | During and after the assessment period in the study, estimated to be 6 hours. | 
| Secondary Outcome Measures: Heart Rate Variability | Heart rate variability during the assessment period will be recorded, monitored and reviewed for changes, estimated to occur over the course of an hour. Additionally, the heart rate variability will be recorded after the assessment period, for approximately 5 hours. | During and after assessment period in the study, estimated to be 6 hours. | 
| Secondary Outcome Measures: NIRS | Brain blood oxy- and de-oxyhemoglobin, TSI, total hemoglobin, using near infra-red spectroscopy. During the assessment period in the study, estimated to occur around one hour. | During the assessment period in the study, estimated to occur over less than an hour. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants