The Calmer Project

NCT ID: NCT01433588

Last Updated: 2018-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2018-05-31

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.

Conditions

Acute Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

The Calmer

Intervention Type: 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.

Standard Care

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

Group Type: PLACEBO_COMPARATOR

Standard of Care

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

Standard of Care

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

Intervention Type: OTHER

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

• Minimum Eligible Age: 27 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's & Women's Health Centre of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Liisa Holsti

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Liisa Holsti, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

BC Children's and Women's Health Centre

Vancouver, British Columbia, Canada

Countries

Canada

Other Identifiers

CALMERP

Identifier Type: -

Identifier Source: org_study_id