The Calmer Project
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|ClinicalTrials.gov Identifier: NCT01433588|
Recruitment Status : Completed
First Posted : September 14, 2011
Last Update Posted : July 17, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Acute Pain||Device: The Calmer Other: Standard of Care||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||Calmer: A Novel Approach for Treating Infant Pain|
|Study Start Date :||October 2014|
|Actual Primary Completion Date :||May 2018|
|Actual Study Completion Date :||May 2018|
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.
- Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: During the assessment period in the study, estimated to occur around one hour. ]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 6 hours. ]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.
- Secondary Outcome Measures: Heart Rate Variability [ Time Frame: During and after assessment period in the study, estimated to be 6 hours. ]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.
- Secondary Outcome Measures: NIRS [ Time Frame: During the assessment period in the study, estimated to occur over less than an hour. ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433588
|Canada, British Columbia|
|BC Children's and Women's Health Centre|
|Vancouver, British Columbia, Canada, V6H3V4|
|Principal Investigator:||Liisa Holsti, PhD||Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC|