Kangaroo mother care combined with sucrose to reduce pain responses in preterm infants
| ISRCTN | ISRCTN73259137 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73259137 |
| Secondary identifying numbers | N/A |
- Submission date
- 01/10/2009
- Registration date
- 20/07/2010
- Last edited
- 20/07/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Ms Ananda Fernandes
Scientific
Scientific
Praceta Falcão Resende, 1, R/Ch
Coimbra
3000-164
Portugal
| Phone | +351 (0)917 500 541 |
|---|---|
| amfernandes@esenfc.pt |
Study information
| Study design | Multicentre randomised controlled clinical 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 | The efficacy of kangaroo mother care combined with oral sucrose to reduce pain responses in preterm infants: a randomised multicentre clinical trial |
| Study objectives | 1. Is kangaroo mother care combined with sucrose more effective than sucrose alone in reducing the pain responses of preterm infants during venipuncture? 2. How do mothers perceive doing kangaroo care while their infant is having a venipuncture? Although kangaroo care is effective in reducing the pain responses of preterm infants to procedural pain, the perceptions of mothers of holding their infant skin-to-skin during venipuncture has not been explored. |
| Ethics approval(s) | Local ethics committees: 1. Comissão de Ética para a Saúde dos Hospitais da Universidade de Coimbra approved on the 9th June 2006 2. Comissão de Ética do Centro Hospitalar de Coimbra approved on the 23rd May 2006 |
| Health condition(s) or problem(s) studied | Procedural pain during venipuncture |
| Intervention | 1. Oral sucrose with pacifier, 2 minutes before venipuncture 2. Kangaroo mother care during 30 minutes before and during venipuncture plus oral sucrose with pacifier 2 minutes before venipuncture Infants were followed until discharge from hospital. |
| Intervention type | Other |
| Primary outcome measure | Pain responses measured by: 1. Premature Infant Pain Profile Scores 2. Changes in heart rate 3. Changes in oxygen saturation 4. Changes in behavioural state 5. Percentage of time displaying facial actions 6. Heart rate variability 7. Recovery time Primary outcome measures were taken at baseline (30 seconds before venipuncture); during skin cleansing; needle stick and blood harvesting; compression after needle removal; and rest (up to 5 minutes after the end of the procedure). |
| Secondary outcome measures | Mothers' perception of doing Kangaroo Care during venipuncture was obtained between one and six days after the venipuncture occurred. |
| Overall study start date | 25/03/2007 |
| Completion date | 01/09/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 120 |
| Key inclusion criteria | 1. Gestational age between 28 and 36 weeks 2. Postnatal age less than 28 days |
| Key exclusion criteria | 1. Apgar score less than 6 at 5 minutes 2. Surgery 3. Major congenital anomalies 4. Genetic anomaly 5. Intra-ventricular haemorrhage (IVH) greater than Grade 2 or subsequent periventricular leucomalacia 6. Severe illness as defined by hypo or hyperthermia, need for respiratory support (ventilation or nasal continuous positive airway pressure [CPAP]), inotropic therapy 7. Presence of umbilical catheter 8. Painful procedure in the previous 12 hours 9. Opioid or non-opioid sedation on the 48 hours prior to data collection 10. Diabetic mother 11. Mother with history of substance abuse 12. Mother absent or unable to do kangaroo care for clinical reasons 13. Mother cannot speak/read Portuguese |
| Date of first enrolment | 25/03/2007 |
| Date of final enrolment | 01/09/2008 |
Locations
Countries of recruitment
- Portugal
Study participating centre
Praceta Falcão Resende, 1, R/Ch
Coimbra
3000-164
Portugal
3000-164
Portugal
Sponsor information
Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
University/education
University/education
Av. Bissaya Barreto
Apartado 55
Coimbra
3001-901
Portugal
| Phone | +351 (0)239 487 200 |
|---|---|
| esenfc@esenfc.pt | |
| Website | http://www.esenfc.pt |
"ROR" |
https://ror.org/03c3y8w73 |
Funders
Funder type
Government
Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Foundation for Science and Technology, Portuguese Science and Technology Foundation, Fundacao para a Ciencia e a Tecnologia, FCT
- Location
- Portugal
Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
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 |
