Kangaroo Care with Father's protocol: an intervention to reduce pain response in preterm neonates (28 - 36 weeks gestation)
| ISRCTN | ISRCTN51481987 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN51481987 |
| Secondary identifying numbers | 2580; MOP-64307 |
- Submission date
- 16/02/2009
- Registration date
- 31/03/2009
- Last edited
- 02/11/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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, room 226
Montreal, QC
H3A 2A7
Montreal
H3A 2A7
Canada
| Phone | +1 514 398 4157 |
|---|---|
| celeste.johnston@mcgill.ca |
Study information
| Study design | Randomised controlled crossover trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| 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 |
| Study acronym | FKC |
| Study objectives | 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(s) | CHU St-Justine Research Ethics Board (REB) gave approval on the 16th July 2007 (ref: 2580) |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/10/2007 |
| Completion date | 01/04/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 80 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/10/2007 |
| Date of final enrolment | 01/04/2009 |
Locations
Countries of recruitment
- Canada
Study participating centre
3506 University, room 226
Montreal
H3A 2A7
Canada
H3A 2A7
Canada
Sponsor information
McGill University (Canada)
University/education
University/education
c/o Dr Celeste Johnston
School of Nursing
3506 University, Room 226
Montreal
H3A 2A7
Canada
| Phone | +1 514 398 4157 |
|---|---|
| celeste.johnston@mcgill.ca | |
| Website | http://www.mcgill.ca |
"ROR" |
https://ror.org/01pxwe438 |
Funders
Funder type
Research organisation
Canadian Institutes 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 | 01/09/2011 | Yes | No |
