The Calmer Project

• 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.

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.

30 infants will be randomized to either receive the standard of care or the Calmer during a routine blood collection.

• 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.
• Other: Standard of Care
  Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.

• 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.
  Intervention: Device: The Calmer
• Placebo Comparator: Standard Care
  Standard of care during bloodwork is receiving a soother and faciliated tucking.
  Intervention: Other: Standard of Care

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