Acute Pain
Conditions
Keywords
Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants
Brief summary
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.
Detailed description
60 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.
Interventions
DEVICEThe 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.
OTHERStandard of Care
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
Sponsors
Children's & Women's Health Centre of British Columbia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
27 Weeks to 36 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Behavioral Indicators of Infant Pain (BIIP) Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Secondary Outcome Measures: Heart Rate | 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 | 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 | 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. |
Countries
Canada
Outcome results
None listed