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Trial of Repeated Analgesia With Kangaroo Care (TRAKC)

This study has been completed.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Mayday Fund
Information provided by (Responsible Party):
Celeste Johnston, IWK Health Centre
ClinicalTrials.gov Identifier:
NCT01561547
First received: March 8, 2012
Last updated: September 17, 2016
Last verified: September 2016
  Purpose

Mothers can provide pain relief to their newborns, even in the context of intensive neonatal care. There is a recent accumulation of data, being analyzed by ourselves in a Cochrane review, that mothers holding their infants in a bare-chested skin-to-skin position, known as Kangaroo Mother Care (KMC), is effective in diminishing pain response during a single painful procedure. While evidence is compelling, leading to recommendations for its use, to date there is not a single study on the repeated efficacy to reduce pain. Current guidelines recommend sweet taste for minor painful procedures. Although there is some controversy about its continued use in this population based on one study with negative neurodevelopmental outcomes as well as its potential interaction with dopaminergic development, oral sucrose (sweet taste) remains efficacious in decreasing pain response over several weeks. The combination of KMC and sucrose is marginally more potent, but again, long term use remains unstudied.

AIMS. To test the repeated efficacy in diminishing pain from heel lance of KMC compared to usual care (sucrose), and of KMC in combination with sucrose by examining each condition at least three times during NICU stay. A secondary aim is to compare these interventions on neurodevelopment at discharge from the NICU.


Condition Intervention Phase
Pain
Development
Behavioral: Kangaroo Mother Care
Dietary Supplement: Sucrose
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?

Resource links provided by NLM:


Further study details as provided by IWK Health Centre:

Primary Outcome Measures:
  • Premature Infant Pain Profile (PIPP) [ Time Frame: At the moment of painful procedure ] [ Designated as safety issue: No ]
    The PIPP is a composite measure of procedural pain and is based on changes from baseline in maximum heart rate and minimum oxygen saturation, and the duration of three facial actions. Data are analyzed in 30 second blocks from the moment the painful procedure begins. Time to return to baseline will also be noted. Scoring is done by assessors blind to the purpose of the study and group assignment.


Secondary Outcome Measures:
  • Neurobehavioral Assessment of Preterm Infants (NAPI) [ Time Frame: 32, 36 and 40 weeks gestational age ] [ Designated as safety issue: No ]
    Two scales of the NAPI will be scored by person blinded to the intervention. These are 1) Motor Development and Vigour and 2) Alertness and Orientation


Enrollment: 242
Study Start Date: June 2012
Study Completion Date: July 2016
Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Kangaroo Mother Care
Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sterile water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.
Behavioral: Kangaroo Mother Care
Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.
Active Comparator: Sucrose
Two minutes before the painful procedure and at the moment of the procedure, the infant will be given 24% sucrose by mouth. The volume is determined by body weight and is not important in terms of efficacy, it is the percentage of sweetness that is important.
Dietary Supplement: Sucrose
24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.
Experimental: Combination Kangaroo Mother Care and Sucrose
Infant is held in skin-to-skin contact with mother at least 15 minutes prior to painful procedure, remains in that position throughout the procedure and after the procedure at least until heart rate returns to baseline. Infant is given sucrose water by mouth. This is for every heel lance and venipuncture, and if possible for tape removal.
Behavioral: Kangaroo Mother Care
Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant. removal.
Dietary Supplement: Sucrose
24% sucrose in volumes between .05 to 2 ml depending on weight of the infant, is inserted by dropper into the infants mouth two minutes before and/or during the painful procedure with up to 3 doses.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • less than 36.0 weeks gestational age
  • mother is generally available to provide kangaroo mother care

Exclusion Criteria:

  • narcotic analgesics
  • surgery in past 48 hrs
  • major congenital anomalies
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561547

Locations
Canada, Nova Scotia
IWKHealthC
Halifax, Nova Scotia, Canada, B3K 6R8
Sponsors and Collaborators
IWK Health Centre
Canadian Institutes of Health Research (CIHR)
Nova Scotia Health Research Foundation
Mayday Fund
Investigators
Principal Investigator: Celeste Johnston, RN, DEd IWK Health Centre
Study Director: Marsha Campbell-Yeo, RN, NNP, PhD IWK Health Centre
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Celeste Johnston, Principal Investigator, IWK Health Centre
ClinicalTrials.gov Identifier: NCT01561547     History of Changes
Other Study ID Numbers: TRAKC  CIHR-NSHRF-Mayday RPP 2446 
Study First Received: March 8, 2012
Last Updated: September 17, 2016
Health Authority: Canada: Ethics Review Committee
Individual Participant Data  
Plan to Share IPD: No
Plan Description: Aggregate data will be available but no individual data will be provided.

Keywords provided by IWK Health Centre:
pain
preterm neonate
sucrose
kangaroo mother care

ClinicalTrials.gov processed this record on December 09, 2016