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ISRCTN
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ISRCTN51481987
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DOI
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10.1186/ISRCTN51481987
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation)
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Scientific title
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Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation): a randomised controlled crossover trial
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Acronym
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FKC
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Serial number at source
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2580; MOP-64307
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Study hypothesis
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There will be a difference in pain response, time to recovery and heart rate variability (HRV) from heel lance in 28 - 36 weeks gestational age Neonatal Intensive Care Unit (NICU) preterm neonates when they are engaged in maternal kangaroo care (KC) compared to when they are engaged in father's KC.
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Lay summary
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Not provided at time of registration
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Ethics approval
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CHU St-Justine Research Ethics Board (REB) gave approval on the 16th July 2007 (ref: 2580)
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Study design
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Randomised controlled crossover trial
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Countries of recruitment
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Canada
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Disease/condition/study domain
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Pain response during heel lancing
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Participants - inclusion criteria
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1. Born between 28 0/7 and 35 6/7 weeks of gestation, either sex
2. Obtained consent
3. Receiving at least two heel lances prior to discharge
4. Within 10 days of hospitalisation
5. Stable according to Neonatal Intensive Care Unit criteria
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Participants - exclusion criteria
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1. Genetic or major congenital disorders
2. Requiring surgery before or during the study period
3. Receiving analgesics or paralysing agents
4. Intra-ventricular haemorrhage (IVH) grade III+ or periventricular leukomalacia (PVL) as confirmed by ultrasound
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Anticipated start date
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01/10/2007
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Anticipated end date
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01/04/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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80
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Interventions
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After obtained informed consent from the mother and the father, the neonate will be randomised to intervention (father first mother second) or control (mother first father second). Kangaroo care involves placing a diaper-clad neonate at an angle of sixty degrees between the breasts or on the chest providing maximal skin-to-skin contact between the infant and the caregiver. The neonate is placed in KC 15 minutes before the painful procedure (heel lance) performed by a hospital technician assigned to the study. The heel lance procedure is relatively standardised across staff and timing and is an aspect of routine care for hospitalised preterm neonates. Each neonate will have two KC sessions filmed; one with the mother and the other one with the father. The measures will be taken for the entire heel lance procedure (one minute of baseline isolette, one minute of baseline kangaroo, one minute of warming, extraction of the blood and return to baseline kangaroo and isolette.
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Primary outcome measure(s)
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1. Pain measured with Premature Infant Pain Profile (PIPP), repeated over 30 second blocks
2. Facial actions of the PIPP scored according to Neonatal Facial Coding System (NFCS)
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Secondary outcome measure(s)
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Timing for return to physiologic baseline measured as the preterm neonate's return to baseline HR after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate.
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Sources of funding
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Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-64307)
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21893645
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Contact name
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Dr
Celeste
Johnston
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Address
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3506 University, room 226
Montreal, QC
H3A 2A7
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City/town
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Montreal
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Zip/Postcode
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H3A 2A7
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Country
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Canada
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Tel
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+1 514 398 4157
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Email
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celeste.johnston@mcgill.ca
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Sponsor
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McGill University (Canada)
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Address
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c/o Dr Celeste Johnston
School of Nursing
3506 University, Room 226
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City/town
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Montreal
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Zip/Postcode
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H3A 2A7
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Country
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Canada
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Tel
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+1 514 398 4157
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Fax
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+1 514 398 8455
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Email
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celeste.johnston@mcgill.ca
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Sponsor website:
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http://www.mcgill.ca
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Date applied
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16/02/2009
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Last edited
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02/11/2011
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Date ISRCTN assigned
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31/03/2009
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