Study Results
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Basic Information
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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2012-06-30
2016-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
Interventions
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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.
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 Criteria
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Inclusion Criteria
* mother is generally available to provide kangaroo mother care
Exclusion Criteria
* surgery in past 48 hrs
* major congenital anomalies
ALL
No
Sponsors
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Canadian Institutes of Health Research (CIHR)
OTHER_GOV
Nova Scotia Health Research Foundation
OTHER_GOV
Mayday Fund
OTHER
IWK Health Centre
OTHER
Responsible Party
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Celeste Johnston
Principal Investigator
Principal Investigators
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Celeste Johnston, RN, DEd
Role: PRINCIPAL_INVESTIGATOR
IWK Health Centre
Marsha Campbell-Yeo, RN, NNP, PhD
Role: STUDY_DIRECTOR
IWK Health Centre
Locations
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IWKHealthC
Halifax, Nova Scotia, Canada
Countries
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References
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Johnston CC, Campbell-Yeo M, Filion F. Paternal vs maternal kangaroo care for procedural pain in preterm neonates: a randomized crossover trial. Arch Pediatr Adolesc Med. 2011 Sep;165(9):792-6. doi: 10.1001/archpediatrics.2011.130.
Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Aita M, Finley GA, Walker CD. Kangaroo mother care diminishes pain from heel lance in very preterm neonates: a crossover trial. BMC Pediatr. 2008 Apr 24;8:13. doi: 10.1186/1471-2431-8-13.
Johnston CC, Stevens B, Pinelli J, Gibbins S, Filion F, Jack A, Steele S, Boyer K, Veilleux A. Kangaroo care is effective in diminishing pain response in preterm neonates. Arch Pediatr Adolesc Med. 2003 Nov;157(11):1084-8. doi: 10.1001/archpedi.157.11.1084.
Johnston CC, Filion F, Snider L, Majnemer A, Limperopoulos C, Walker CD, Veilleux A, Pelausa E, Cake H, Stone S, Sherrard A, Boyer K. Routine sucrose analgesia during the first week of life in neonates younger than 31 weeks' postconceptional age. Pediatrics. 2002 Sep;110(3):523-8. doi: 10.1542/peds.110.3.523.
Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. doi: 10.1002/14651858.CD001069.pub3.
Vinall J, Noel M, Disher T, Caddell K, Campbell-Yeo M. Memories of Infant Pain in the Neonatal Intensive Care Unit Influence Posttraumatic Stress Symptoms in Mothers of Infants Born Preterm. Clin J Pain. 2018 Oct;34(10):936-943. doi: 10.1097/AJP.0000000000000620.
Campbell-Yeo M, Johnston C, Benoit B, Latimer M, Vincer M, Walker CD, Streiner D, Inglis D, Caddell K. Trial of repeated analgesia with Kangaroo Mother Care (TRAKC Trial). BMC Pediatr. 2013 Nov 9;13:182. doi: 10.1186/1471-2431-13-182.
Other Identifiers
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CIHR-NSHRF-Mayday RPP 2446
Identifier Type: OTHER
Identifier Source: secondary_id
TRAKC
Identifier Type: -
Identifier Source: org_study_id
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