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The Calmer Project

This study is currently recruiting participants.
Verified February 2017 by Liisa Holsti, Children's & Women's Health Centre of British Columbia
Sponsor:
ClinicalTrials.gov Identifier:
NCT01433588
First Posted: September 14, 2011
Last Update Posted: February 23, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Liisa Holsti, Children's & Women's Health Centre of British Columbia
  Purpose

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.


Condition Intervention
Acute Pain Device: The Calmer Other: Standard of Care

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Calmer: A Novel Approach for Treating Infant Pain

Further study details as provided by Liisa Holsti, Children's & Women's Health Centre of British Columbia:

Primary Outcome Measures:
  • Change in Behavioral Indicators of Infant Pain (BIIP) Score [ Time Frame: 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 Outcome Measures:
  • Secondary Outcome Measures: Heart Rate [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.


Estimated Enrollment: 60
Study Start Date: October 2014
Estimated Study Completion Date: August 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Placebo Comparator: Standard Care
Standard of care during bloodwork is receiving a soother and facilitated tucking.
Other: Standard of Care
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   27 Weeks to 36 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01433588


Contacts
Contact: Jennifer Claydon, MSc 604-875-2000 ext 7408 jclaydon@cw.bc.ca

Locations
Canada, British Columbia
BC Children's and Women's Health Centre Recruiting
Vancouver, British Columbia, Canada, V6H3V4
Contact: Liisa Holsti, PhD    604-875-2000 ext 5200    liisaholsti@ubc.ca   
Contact: Jennifer Claydon, MSc    604-875-2000 ext 7408    jclaydon@cw.bc.ca   
Principal Investigator: Liisa Holsti, PhD         
Sponsors and Collaborators
Children's & Women's Health Centre of British Columbia
Investigators
Principal Investigator: Liisa Holsti, PhD Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
  More Information

Responsible Party: Liisa Holsti, Associate Professor, Children's & Women's Health Centre of British Columbia
ClinicalTrials.gov Identifier: NCT01433588     History of Changes
Other Study ID Numbers: CALMERP
First Submitted: September 9, 2011
First Posted: September 14, 2011
Last Update Posted: February 23, 2017
Last Verified: February 2017

Keywords provided by Liisa Holsti, Children's & Women's Health Centre of British Columbia:
Managing infant pain
27 - 36+6 weeks gestation
Preterm infants

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms


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