Enhanced MotherCARE for procedural pain in preterm neonates
| ISRCTN | ISRCTN13550119 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13550119 |
| Secondary identifying numbers | MOP-64307 |
- Submission date
- 26/03/2006
- Registration date
- 27/06/2006
- Last edited
- 27/03/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Celeste Johnston
Scientific
Scientific
3506 University Street
Room 226
Montreal
H3A 2A7
Canada
Study information
| Study design | Randomised cross-over design |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Maternal comfort, analgesia, regulation, endorphin-release: mothercare, a program of research for pain in critically ill infants and toddlers |
| Study acronym | Enhanced MotherCARE |
| Study objectives | 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(s) | McGill University Health Centre (full board review) approved on the 20th November 2003 (ref: MCH003-48) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/12/2003 |
| Completion date | 01/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 80 |
| Key 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. |
| Key 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 |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/12/2006 |
Locations
Countries of recruitment
- Canada
Study participating centre
3506 University Street
Montreal
H3A 2A7
Canada
H3A 2A7
Canada
Sponsor information
McGill University (Canada)
University/education
University/education
3506 University Street
Room 226
Montreal
H3A 2A7
Canada
| Website | http://www.mcgill.ca/ |
|---|---|
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Research organisation
Canadian Institute of Health Research (Canada) - http://www.cihr-irsc.gc.ca (ref: MOP 64307)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/01/2009 | Yes | No |
