The Calmer Project
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
|Official Title:||Calmer: A Novel Approach for Treating Infant Pain|
- Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: during the assessment period in the study, estimated to occur over less than an hour. ] [ Designated as safety issue: No ]The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
- Secondary Outcome Measures: Heart Rate [ Time Frame: during and after the assessment period in the study, estimated to be an hour ] [ Designated as safety issue: No ]Heart rate will be recorded during the assessment period, one hour, to denote changes.
- Secondary Outcome Measures: Heart Rate Variability [ Time Frame: during and after assessment period in the study, estimated to be an hour ] [ Designated as safety issue: No ]Heart rate variability during the assessment period will be recorded, monitored and reviewed for changes, estimated to occur over the course of an hour.
|Study Start Date:||February 2014|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Active Comparator: Calmer
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
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.
Placebo Comparator: Standard Care
Standard of care during bloodwork is receiving a soother and facilitated tucking.
Other: Standard of Care
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433588
|Contact: Jennifer Claydon, MSc||604-875-2000 ext firstname.lastname@example.org|
|Canada, British Columbia|
|BC Children's and Women's Health Centre||Not yet recruiting|
|Vancouver, British Columbia, Canada, V6H3V4|
|Contact: Liisa Holsti, PhD 604-875-2000 ext 5200 email@example.com|
|Contact: Jennifer Claydon, MSc 604-875-2000 ext 7408 firstname.lastname@example.org|
|Principal Investigator: Liisa Holsti, PhD|
|Principal Investigator:||Liisa Holsti, PhD||Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC|