Trial of Repeated Analgesia With Kangaroo Care (TRAKC)

This study is not yet open for participant recruitment.

Verified March 2012 by IWK Health Centre

Sponsor:

Collaborators:

Canadian Institutes of Health Research (CIHR)

Nova Scotia Health Research Foundation

The Mayday Fund

Information provided by (Responsible Party):

Celeste Johnston, IWK Health Centre

ClinicalTrials.gov Identifier:

NCT01561547

First received: March 8, 2012

Last updated: March 22, 2012

Last verified: March 2012

History of Changes

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:

Drug Information available for: Sucrose

U.S. FDA Resources

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

Estimated Enrollment:	285
Study Start Date:	June 2012
Estimated Primary Completion Date:	December 2015 (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

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

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

Contacts

Contact: Marsha Campbell-Yeo, RN, NNP, PhD	(902) 470-7455	Marsha.CampbellYeo@iwk.nshealth.ca
Contact: Kim Caddell, RN, BS	(902)4706704	Kim Caddell <kim.caddell@iwk.nshealth.ca>

Locations

Canada, Nova Scotia
IWKHealthC	Not yet recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Marsha Campbell-Yeo, RN, NNP, PhD (902) 470-7455 marsha.campbellyeo@iwk.nshealth.ca
Contact: Kim Caddell, RN,BS kim.caddell@iwk.nshealth.ca
Principal Investigator: Celeste Johnston, RN, DEd
Principal Investigator: Marsha Campbell-Yeo, RN, NNP, PhD

Sponsors and Collaborators

IWK Health Centre

Canadian Institutes of Health Research (CIHR)

Nova Scotia Health Research Foundation

The 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:

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.

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.

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.

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.

Stevens B, Yamada J, Ohlsson A. Sucrose for analgesia in newborn infants undergoing painful procedures. Cochrane Database Syst Rev. 2010 Jan 20;(1):CD001069. Review.

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:	March 22, 2012
Health Authority:	Canada: Ethics Review Committee

Keywords provided by IWK Health Centre:

pain
preterm neonate
sucrose
kangaroo mother care

ClinicalTrials.gov processed this record on May 23, 2013

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