- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01433588
The Calmer Project
Calmer: A Novel Approach for Treating Infant Pain
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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British Columbia
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Vancouver, British Columbia, Canada, V6H3V4
- BC Children's and Women's Health Centre
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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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.
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Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Behavioral Indicators of Infant Pain (BIIP) Score
Time Frame: During the assessment period in the study, estimated to occur around one hour.
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The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
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During the assessment period in the study, estimated to occur around one hour.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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During and after the assessment period in the study, estimated to be 6 hours.
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Secondary Outcome Measures: Heart Rate Variability
Time Frame: During and after assessment period in the study, estimated to be 6 hours.
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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.
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During and after assessment period in the study, estimated to be 6 hours.
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Secondary Outcome Measures: NIRS
Time Frame: During the assessment period in the study, estimated to occur over less than an hour.
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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.
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During the assessment period in the study, estimated to occur over less than an hour.
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Collaborators and Investigators
Investigators
- Principal Investigator: Liisa Holsti, PhD, Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CALMERP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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