Support Centre
23 October 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

New application
Updating record

governing board
data set
letter of agreement
request information
guidance notes

[ Print-friendly version ]
Maternal kangaroo care for procedural pain in very preterm neonates
DOI 10.1186/ISRCTN63551708
ClinicalTrials.gov identifier
EudraCT number
Public title Maternal kangaroo care for procedural pain in very preterm neonates
Scientific title Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers
Acronym MotherCARE
Serial number at source MOP-64307
Study hypothesis Preterm infants less than 32 weeks post-menstrual age (pma) will have greater physiologic stability and decreased salivary cortisol response to heel stick procedure during skin-skin contact than prone in isolette.
Lay summary
Ethics approval Approved by McGill University Health Centre (full board review) on 20th November 2003 (ref: MCH003-48)
Study design Randomised cross-over design
Countries of recruitment Canada
Disease/condition/study domain Physiologic stability in preterm infants
Participants - inclusion criteria Infants born between 28 0/7 and 32 6/7 weeks pma as determined by an ultrasound will be eligible
Participants - exclusion criteria 1. Genetic or major congenital disorders
2. Requiring surgery before or during the study period
3. Receiving analgesics, paralysing agents or steroid therapy
4. Apgar scores less than 6 at five minutes
5. Intraventricular haemorrhage (IVH) grade III and/or periventricular leukomalacia (PVL) as confirmed by ultrasound
Anticipated start date 01/12/2003
Anticipated end date 01/01/2006
Status of trial Completed
Patient information material
Target number of participants 64
Interventions Skin-to-skin contact: the diaper-clad infant will be held upright at an angle of sixty degrees between the breasts of the mother during a routine heel stick procedure. A blanket will be placed over the infants back throughout the intervention. The baby will remain in this condition for 15 minutes prior to heel lance, during the procedure and until the infant returns to baseline heart rate after the procedure is completed. In the control group, the infant will be in the prone position in the isolette.
Primary outcome measure(s) Physiologic stability:
1. Maximum range of heart rate and O2 saturation from baseline throughout the procedure
2. Time to return to baseline heart rate and O2 saturation
Secondary outcome measure(s) Stress response: measured through the procurement of salivary cortisol collected prior to (basal) and 30 minutes after (stress response) the heel stick procedure for both the mother and the infant
Sources of funding Canadian Institute of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP-64307)
Trial website
Publications 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18435837
Contact name Dr  Celeste  Johnston
  Address 3506 University Street
Room 226
  City/town Montreal
  Zip/Postcode H3A 2A7
  Country Canada
Sponsor McGill University (Canada)
  Address 3506 University Street
Room 226
  City/town Montreal
  Zip/Postcode H3A 2A7
  Country Canada
  Sponsor website: http://www.mcgill.ca/
Date applied 26/03/2006
Last edited 27/03/2009
Date ISRCTN assigned 27/06/2006
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.