Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MOP-64307
Study information
Scientific title
Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers
Acronym
Enhanced MotherCARE
Study hypothesis
Physiological pain and stress response will be lower in maternally enhanced skin-skin contact (SSC) than SSC in preterm neonates of 32 - 36 weeks.
Ethics approval
McGill University Health Centre (full board review) approved on the 20th November 2003 (ref: MCH003-48)
Study design
Randomised cross-over design
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Pain response
Intervention
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.
Maternally-enhanced skin-skin contact: throughout the procedure, the mother will be seated with her infant in a rocking chair and will be asked to recite rhymes or sing songs to her infant. This will begin 15 minutes prior to heel stick. Just before the heel stick procedure, she will be asked to insert the tip of her well-trimmed smallest finger into the baby's mouth for the baby to suck. One minute later, the procedure will begin by collecting baseline data.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
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 measures
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.
Overall trial start date
01/12/2003
Overall trial end date
01/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Infants born between 28 0/7 and 32 6/7 weeks post-menstrual age (PMA) as determined by an ultrasound will be eligible.
Participant type
Patient
Age group
Child
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, paralyzing 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
Recruitment start date
01/12/2003
Recruitment end date
01/12/2006
Locations
Countries of recruitment
Canada
Trial participating centre
3506 University Street
Montreal
H3A 2A7
Canada
Sponsor information
Organisation
McGill University (Canada)
Sponsor details
3506 University Street
Room 226
Montreal
H3A 2A7
Canada
Sponsor type
University/education
Website
Funders
Funder type
Research organisation
Funder name
Canadian Institute 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
2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18769382
Publication citations
-
Results
Johnston CC, Filion F, Campbell-Yeo M, Goulet C, Bell L, McNaughton K, Byron J, Enhanced kangaroo mother care for heel lance in preterm neonates: a crossover trial., J Perinatol, 2009, 29, 1, 51-56, doi: 10.1038/jp.2008.113.