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The Calmer Project

Primary Purpose

Acute Pain

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
The Calmer
Standard of Care
Sponsored by
Children's & Women's Health Centre of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Acute Pain focused on measuring Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants

Eligibility Criteria

27 Weeks - 36 Weeks (Child)All SexesDoes not accept 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

Sites / Locations

  • BC Children's and Women's Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Calmer

Standard Care

Arm 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.

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

Outcomes

Primary Outcome Measures

Change in Behavioral Indicators of Infant Pain (BIIP) Score
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
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
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
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.

Full Information

First Posted
September 9, 2011
Last Updated
July 16, 2018
Sponsor
Children's & Women's Health Centre of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT01433588
Brief Title
The Calmer Project
Official Title
Calmer: A Novel Approach for Treating Infant Pain
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Children's & Women's Health Centre of British Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pain
Keywords
Managing infant pain, 27 - 36+6 weeks gestation, Preterm infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
54 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Calmer
Arm Type
Active Comparator
Arm 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.
Arm Title
Standard Care
Arm Type
Placebo Comparator
Arm Description
Standard of care during bloodwork is receiving a soother and facilitated tucking.
Intervention Type
Device
Intervention Name(s)
The Calmer
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.
Primary Outcome Measure Information:
Title
Change in Behavioral Indicators of Infant Pain (BIIP) Score
Description
The Behavioral Indicators of Infant Pain (BIIP) is a reliable and valid scale for assessing acute procedural pain in preterm infants.
Time Frame
During the assessment period in the study, estimated to occur around one hour.
Secondary Outcome Measure Information:
Title
Secondary Outcome Measures: Heart Rate
Description
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.
Time Frame
During and after the assessment period in the study, estimated to be 6 hours.
Title
Secondary Outcome Measures: Heart Rate Variability
Description
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.
Time Frame
During and after assessment period in the study, estimated to be 6 hours.
Title
Secondary Outcome Measures: NIRS
Description
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.
Time Frame
During the assessment period in the study, estimated to occur over less than an hour.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
27 Weeks
Maximum Age & Unit of Time
36 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liisa Holsti, PhD
Organizational Affiliation
Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC
Official's Role
Principal Investigator
Facility Information:
Facility Name
BC Children's and Women's Health Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H3V4
Country
Canada

12. IPD Sharing Statement

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The Calmer Project

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