The Calmer Project

This study is not yet open for participant recruitment.
Verified February 2014 by Children's & Women's Health Centre of British Columbia
Sponsor:
Information provided by:
Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier:
NCT01433588
First received: September 9, 2011
Last updated: February 10, 2014
Last verified: February 2014

September 9, 2011
February 10, 2014
February 2014
December 2016   (final data collection date for primary outcome measure)
Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: during the assessment period in the study, estimated to occur over less than an hour. ] [ Designated as safety issue: No ]
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
Same as current
Complete list of historical versions of study NCT01433588 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
The Calmer Project
Calmer: A Novel Approach for Treating Infant Pain

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Supportive Care
Acute Pain
  • Device: The 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.
  • 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 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.
    Intervention: Device: The Calmer
  • Placebo Comparator: Standard Care
    Standard of care during bloodwork is receiving a soother and facilitated tucking.
    Intervention: Other: Standard of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
60
December 2016
December 2016   (final data collection date for primary outcome measure)

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
Both
27 Weeks to 36 Weeks
No
Contact: Jennifer Claydon, MSc 604-875-2000 ext 7408 jclaydon@cw.bc.ca
Canada
 
NCT01433588
CALMERP
No
Not Provided
Children's & Women's Health Centre of British Columbia
Not Provided
Principal Investigator: Liisa Holsti, PhD Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
Children's & Women's Health Centre of British Columbia
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP