The Calmer Project
This study is currently recruiting participants.
Verified September 2011 by Children's & Women's Health Centre of British Columbia
Sponsor:
Children's & Women's Health Centre of British Columbia
Information provided by:
Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01433588
First received: September 9, 2011
Last updated: May 30, 2012
Last verified: September 2011
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Purpose
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: When positioned on the 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 | Intervention |
|---|---|
|
Acute Pain |
Device: The Calmer Other: Standard of Care |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Supportive Care |
| Official Title: | The Calmer: Pilot Testing a Robot for Managing Acute Pain in Preterm Infants in the Neonatal Intensive Care Nursery (NICU). |
Resource links provided by NLM:
Further study details as provided by Children's & Women's Health Centre of British Columbia:
Primary Outcome Measures:
- 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:
- 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.
| Estimated Enrollment: | 30 |
| Study Start Date: | October 2011 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Calmer
This therapeutic platform, called the Calmer, moves up and down gently to simulate a breathing motion. It also can play a heart beat sound and is covered with a soft surface which is like skin. 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, moves up and down gently to simulate a breathing motion. It also can play a heart beat sound and is covered with a soft surface which is like skin. Infants can be placed on it for cares to mimic Kangaroo Care, maternal skin to skin.
|
|
Placebo Comparator: Standard Care
Standard of care during bloodwork is receiving a soother and faciliated tucking.
|
Other: Standard of Care
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
|
Detailed Description:
30 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Eligibility| Ages Eligible for Study: | 27 Weeks to 35 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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 27-35 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 not in an incubator
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433588
Contacts
| Contact: Nadine Lusney, BNSc | 604-875-2000 ext 5550 | nlusney@cw.bc.ca |
| Contact: Jennifer Claydon, MSc | 604-875-2000 ext 7408 | jclaydon@cw.bc.ca |
Locations
| Canada, British Columbia | |
| BC Children's and Women's Health Centre | Recruiting |
| Vancouver, British Columbia, Canada, V6H3V4 | |
| Contact: Liisa Holsti, PhD 604-875-2000 ext 5200 lholsti@cw.bc.ca | |
| Contact: Jennifer Claydon, MSc 604-875-2000 ext 7408 jclaydon@cw.bc.ca | |
| Principal Investigator: Liisa Holsti, PhD | |
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT01433588 History of Changes |
| Other Study ID Numbers: | CALMERP |
| Study First Received: | September 9, 2011 |
| Last Updated: | May 30, 2012 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Children's & Women's Health Centre of British Columbia:
|
Empathetic robot 27-35 weeks gestation Preterm infants |
ClinicalTrials.gov processed this record on May 22, 2013