The Calmer Project

• ClinicalTrials.gov Identifier: NCT01433588
• Recruitment Status: Completed
• First Posted: September 14, 2011
• Last Update Posted: July 17, 2018
• Sponsor: Children's & Women's Health Centre of British Columbia
• Information provided by (Responsible Party): Liisa Holsti, Children's & Women's Health Centre of British Columbia

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.

Condition or disease	Intervention/treatment	Phase
Acute Pain	Device: The Calmer; Other: Standard of Care	Not Applicable

Detailed Description:

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

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 54 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Supportive Care
• Official Title: Calmer: A Novel Approach for Treating Infant Pain
• Study Start Date: October 2014
• Actual Primary Completion Date: May 2018
• Actual Study Completion Date: May 2018

Arms and Interventions

Arm	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. 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.

Eligibility Criteria

• 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

Locations

Canada, British Columbia

BC Children's and Women's Health Centre

Vancouver, British Columbia, Canada, V6H3V4

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
• Other Study ID Numbers: CALMERP
• First Posted: September 14, 2011
• Last Update Posted: July 17, 2018
• Last Verified: July 2018

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