The Calmer Project

This study is currently recruiting participants. (see Contacts and Locations)

Verified August 2015 by Children's & Women's Health Centre of British Columbia

Sponsor:

Information provided by (Responsible Party):

Liisa Holsti, Children's & Women's Health Centre of British Columbia

ClinicalTrials.gov Identifier:

NCT01433588

First received: September 9, 2011

Last updated: August 11, 2015

Last verified: August 2015

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Supportive Care
Official Title:	Calmer: A Novel Approach for Treating Infant Pain

Further study details as provided by 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. ] [ 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.

Secondary Outcome Measures:

Secondary Outcome Measures: Heart Rate [ Time Frame: During and after the assessment period in the study, estimated to be 6 hours. ] [ Designated as safety issue: No ]
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. ] [ 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. 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. ] [ Designated as safety issue: No ]
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:	January 2017
Estimated Primary Completion Date:	January 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


Ages Eligible for Study:	27 Weeks to 36 Weeks (Child)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 lholsti@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
Study First Received:	September 9, 2011
Last Updated:	August 11, 2015
Health Authority:	Canada: Ethics Review Committee

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016

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