- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01561547
Trial of Repeated Analgesia With Kangaroo Care (TRAKC)
Maternal Analgesia for Procedural Pain in Preterm Neonates: Does It Remain Efficacious?
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Nova Scotia
-
Halifax, Nova Scotia, Canada, B3K 6R8
- IWKHealthC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
Infant wearing only diaper is held in skin-to-skin contact with mother with flannel blanket around both mother and infant.
removal.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Premature Infant Pain Profile (PIPP)
Time Frame: At the moment of painful procedure
|
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.
|
At the moment of painful procedure
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neurobehavioral Assessment of Preterm Infants (NAPI)
Time Frame: 32, 36 and 40 weeks gestational age
|
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
|
32, 36 and 40 weeks gestational age
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Celeste Johnston, RN, DEd, IWK Health Centre
- Study Director: Marsha Campbell-Yeo, RN, NNP, PhD, IWK Health Centre
Publications and helpful links
General Publications
- 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, 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, 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- TRAKC
- CIHR-NSHRF-Mayday RPP 2446 (Other Identifier: CIHR-NSHRF-Mayday Fund RPP 244640)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Pain
-
Flowonix MedicalApproved for marketingBack Pain | Leg Pain | Trunk Pain | Intractable Pain | Arm Pain
-
University Hospital Schleswig-HolsteinZealand University Hospital; European Regional Development Fund; Design School...CompletedPain, Acute | Pain, Chronic | Pain Measurement | Pain, CancerGermany
-
Universitat Jaume ICompletedPain, Acute | Pain, Chronic | OncologySpain
-
Dr. Negrin University HospitalCompletedPostoperative Pain, Acute | Postoperative Pain, ChronicSpain
-
George Washington UniversityRecruitingCervical Fusion | Pain, Back | Pain, Neck | Myofacial PainUnited States
-
Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
-
Atatürk Chest Diseases and Chest Surgery Training...RecruitingPostoperative Pain | Postoperative Pain, Acute | Postoperative Pain, Chronic | VATSTurkey
-
Janssen Research & Development, LLCCompletedPain, Radiating | Pain, Burning | Pain, Crushing | Pain, Migratory | Pain, SplittingUnited States, France, Spain, Poland, Portugal
-
University of Campinas, BrazilCompletedPREGNANCY | LUMBAR BACK PAIN | PELVIC PAIN
-
susanne beckerSNSFCompletedLow Back Pain | Pain, Acute | Pain, ChronicSwitzerland
Clinical Trials on Kangaroo Mother Care
-
University of the PhilippinesPfizerCompletedLow Birth Weight Among NeonatesPhilippines
-
University of Alabama at BirminghamCompleted
-
Rajiv BahlEmory University; Hawassa University; Mekelle University; Emory University EthiopiaCompleted
-
Addis Ababa UniversityWorld Health Organization; Harvard School of Public Health (HSPH)CompletedLow Birth-weightEthiopia
-
Society for Applied StudiesCentre For International HealthCompleted
-
Saglik Bilimleri UniversitesiRecruitingPremature Infant | Mother-Infant Interaction | Fathers | Kangaroo CareTurkey
-
University of South CarolinaGhana Health Services; Korle-Bu Teaching Hospital, Accra, Ghana; Centre for Learning...Not yet recruiting
-
University of Alabama at BirminghamCompleted
-
Fatih UniversityUnknownImmaturity | Oral Intolerance | Postnatal AdaptationTurkey