Contact information
Type
Scientific
Primary contact
Dr Celeste Johnston
ORCID ID
Contact details
3506 University
room 226
Montreal
QC
H3A 2A7
Montreal
H3A 2A7
Canada
+1 514 398 4157
celeste.johnston@mcgill.ca
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2580; MOP-64307
Study information
Scientific title
Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation): a randomised controlled crossover trial
Acronym
FKC
Study hypothesis
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.
Ethics approval
CHU St-Justine Research Ethics Board (REB) gave approval on the 16th July 2007 (ref: 2580)
Study design
Randomised controlled crossover trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Pain response during heel lancing
Intervention
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.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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)
Secondary outcome measures
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.
Overall trial start date
01/10/2007
Overall trial end date
01/04/2009
Reason abandoned
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
80
Participant exclusion criteria
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
Recruitment start date
01/10/2007
Recruitment end date
01/04/2009
Locations
Countries of recruitment
Canada
Trial participating centre
3506 University, room 226
Montreal
H3A 2A7
Canada
Sponsor information
Organisation
McGill University (Canada)
Sponsor details
c/o Dr Celeste Johnston
School of Nursing
3506 University
Room 226
Montreal
H3A 2A7
Canada
+1 514 398 4157
celeste.johnston@mcgill.ca
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institutes of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-64307)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21893645
Publication citations
-
Results
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, 165, 9, 792-796, doi: 10.1001/archpediatrics.2011.130.