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The Calmer Project

NCT01433588 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2018-07-17

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Liisa Holsti, PhD · Developmental Neurosciences and Child Health, Child and Family Research Institute and Dept. of Occupational Science and Occupational Therapy, UBC

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
27 Weeks
Max Age
36 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2018-05-31
Completion
2018-05-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01433588 on ClinicalTrials.gov