The Calmer Project

Acute Pain Clinical Trial

Official title:

Calmer: A Novel Approach for Treating Infant Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01433588
• Other study ID #: CALMERP
• Status: Completed
• Phase: N/A
• Start date: October 2014
• Est. completion date: May 2018

Study information

• Verified date: July 2018
• Source: Children's & Women's Health Centre of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 27 Weeks to 36 Weeks

Eligibility

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

Related Conditions & MeSH terms

• Acute Pain

Intervention

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.

Locations

Country	Name	City	State
Canada	BC Children's and Women's Health Centre	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Children's & Women's Health Centre of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the assessment period in the study, estimated to occur around one hour.
Secondary	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.	During and after the assessment period in the study, estimated to be 6 hours.
Secondary	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.	During and after assessment period in the study, estimated to be 6 hours.
Secondary	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.	During the assessment period in the study, estimated to occur over less than an hour.