Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Calmer | Active Comparator | 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. |
|
| Standard Care | Placebo Comparator | Standard of care during bloodwork is receiving a soother and facilitated tucking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Calmer | Device | 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. |
| 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. |
| 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Liisa Holsti, PhD | Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| BC Children's and Women's Health Centre | Vancouver | British Columbia | V6H3V4 | Canada |
Not provided
| ID | Term |
|---|---|
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard of Care | Other | Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking. |
|
| 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. |