Alternative Female Kangaroo Care: an intervention to reduce pain response in preterm neonates (28 - 36 weeks)
| ISRCTN | ISRCTN71855294 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71855294 |
| Secondary identifying numbers | A09-B33-06A |
- Submission date
- 19/07/2007
- Registration date
- 03/10/2007
- Last edited
- 19/07/2021
- 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
H3A 2A7
Canada
Study information
| Study design | This study is a test of non-inferiority or alternate mother KC versus maternal KC. It is a crossover design where neonates served as their own control. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Alternative Female Kangaroo Care: an intervention to reduce pain response in preterm neonates (28 - 36 weeks) |
| Study acronym | AFKC |
| Study objectives | Primary hypothesis: There will be no difference in pain response and time to recovery 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 Alternative Female Kangaroo Care (AFKC). |
| Ethics approval(s) | Study approved by McGill University Institutional Review Board (IRB) on 11th September 2006 (ref: A09-B33-06A). |
| Health condition(s) or problem(s) studied | Pain response |
| Intervention | After obtained informed consent from the mother and the alternative female, the neonate will be randomised to: 1. Control group: mother first and alternative female second, or 2. Treatment group: alternative female first and mother second Kangaroo Care involves placing a diaper-clad neonate at an angle of sixty degrees between the breasts providing maximal skin-to-skin contact between the infant and the caregiver. The neonate is placed in KC for 15 minutes before the painful procedure (heelstick) performed by a hospital technician assigned to the study. The alternative female will wear a mask if she did not visit her general practioner for good health within two days of the treatment condition. All alternate females will wash their chest with an non-scented soap common to the NICU and will respect the hand washing procedures recommended by the NICU. 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 one with the alternative female. The measures will be taken for the entire heel-lance procedure (one minute baseline, one minute warming of the neonate's foot, stick, extraction of the blood and return to baseline). Second sponsor: Canadian Nurses Foundation (Canadian Nurses Fondation [CNF]) 50 Driveway Ottawa, Ontario K2P 1E2 Canada |
| Intervention type | Other |
| Primary outcome measure | 1. Pain measured with Premature Infant Pain Profile (PIPP) 2. Facial actions of the PIPP scored according to Neonatal Facial Coding System (NFCS) |
| Secondary outcome measures | Time for return to physiological baseline measured as the preterm neonate's return to baseline Heart Rate (HR) after the heel lance procedure procured via an oximeter placed on the unaffected foot of the neonate. |
| Overall study start date | 11/09/2006 |
| Completion date | 11/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | N = 64, power = 0.8, alpha = 0.05 using the PIPP with a difference of 1 point of the PIPP scale. |
| Total final enrolment | 18 |
| Key inclusion criteria | 1. Born between 28 0/7 weeks and 36 6/7 gestational age 2. Obtained consent 3. Receiving at least two heel lances prior to discharge 4. Within 10 days of hospitalisation 5. Neonate has to be stable according to the Neonatal Intensive Care Unit criteria 6. Alternate female had to be healthy and older than 18 years old |
| Key exclusion criteria | Does not comply with the inclusion criteria. |
| Date of first enrolment | 11/09/2006 |
| Date of final enrolment | 11/09/2008 |
Locations
Countries of recruitment
- Canada
Study participating centre
3506 University, room 226
Montreal
H3A 2A7
Canada
H3A 2A7
Canada
Sponsor information
Montreal Inter-University Group for Nursing Research (GRISIM) (Canada)
Research organisation
Research organisation
3875, rue St-Urbain
Bureau 205
Montreal
H2W 1V1
Canada
| Website | http://www.grisim.ca/index.php?L=1 |
|---|
Funders
Funder type
Research organisation
Quebec Health Research Fund (Fonds de recherche en Santé du Québec [FRSQ])/Montreal Inter-University Group for Nursing Research (Groupe de Recherche Interuniversitaire en Sciences Infirmières de Montréal [GRISIM]) (Canada)
No information available
Canadian Nurses Foundation (Canadian Nurses Fondation [CNF]) (Canada)
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 | 01/11/2012 | 19/07/2021 | Yes | No |
Editorial Notes
19/07/2021: Publication reference and total final enrolment added.
