The Calmer Project

Children's & Women's Health Centre of British Columbia

Status: Completed

Conditions: Acute Pain

Treatments: Device: The Calmer; Other: Standard of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01433588

CALMERP

Details and patient eligibility

About

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.

Full description

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

Enrollment: 54 patients

Sex: All

Ages: 27 to 36 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 2 patient groups, including a placebo group

Calmer

Active Comparator group

Description:

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.

Treatment:

Device: The Calmer

Standard Care

Placebo Comparator group

Description:

Standard of care during bloodwork is receiving a soother and facilitated tucking.

Treatment:

Other: Standard of Care