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Completed

NCT Number: NCT01433588

The Calmer Project

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.

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Key information

Conditions

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

Age range

27 week–36 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BC Children's and Women's Health Centre

Vancouver, British Columbia, V6H3V4, Canada

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Standard of care

Other

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Calmer: A Novel Approach for Treating Infant Pain

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 14, 2011
Registry last updated
Jul 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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