Acute Pain Clinical Trial
Official title:
Calmer: A Novel Approach for Treating Infant Pain
NCT number | NCT01433588 |
Other study ID # | CALMERP |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2014 |
Est. completion date | May 2018 |
Verified date | July 2018 |
Source | Children's & Women's Health Centre of British Columbia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 54 |
Est. completion date | May 2018 |
Est. primary completion date | May 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 27 Weeks to 36 Weeks |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | BC Children's and Women's Health Centre | Vancouver | British Columbia |
Lead Sponsor | Collaborator |
---|---|
Children's & Women's Health Centre of British Columbia |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | 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. | |
Secondary | 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 | 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. |
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