The Calmer Project

NCT01433588 | Completed

• 1 other identifier: CALMERP
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Pain

Keywords

Managing infant pain; 27 - 36+6 weeks gestation; Preterm infants

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Secondary Outcome Measures: Heart Rate

  During and after the assessment period in the study, estimated to be 6 hours.

• Secondary Outcome Measures: Heart Rate Variability

  During and after assessment period in the study, estimated to be 6 hours.

• Secondary Outcome Measures: NIRS

  During the assessment period in the study, estimated to occur over less than an hour.

Study Arms (2)

Calmer

ACTIVE COMPARATOR

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

Standard Care

PLACEBO COMPARATOR

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

Other: Standard of Care

Interventions

The Calmer DEVICE

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.

Calmer

Standard of Care OTHER

Infant would receive the standard of care for bloodwork, provided a soother and facilitated tucking.

Standard Care

Eligibility Criteria

• Age: 27 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's & Women's Health Centre of British Columbia: lead

Study Sites (1)

BC Children's and Women's Health Centre

Vancouver, British Columbia, V6H3V4, Canada

Location

MeSH Terms

Conditions

Acute Pain

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Liisa Holsti, PhD

  Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 9, 2011
• First Posted: September 14, 2011
• Study Start: October 1, 2014
• Primary Completion: May 1, 2018
• Study Completion: May 1, 2018
• Last Updated: July 17, 2018

Record last verified: 2018-07

Locations

CA (1)