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06 September 2010
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| [ Print-friendly version ] |
| Kangaroo mother care combined with sucrose to reduce pain responses in preterm infants |
| ISRCTN | ISRCTN73259137 |
| ClinicalTrials.gov identifier | |
| Public title | Kangaroo mother care combined with sucrose to reduce pain responses in preterm infants |
| Scientific title | The efficacy of kangaroo mother care combined with oral sucrose to reduce pain responses in preterm infants: a randomised multicentre clinical trial |
| Acronym | N/A |
| Serial number at source | N/A |
| Study hypothesis |
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 |
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 |
| Study design | Multicentre randomised controlled clinical trial |
| Countries of recruitment | Portugal |
| Disease/condition/study domain | Procedural pain during venipuncture |
| Participants - inclusion criteria |
1. Gestational age between 28 and 36 weeks
2. Postnatal age less than 28 days |
| Participants - 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 |
| Anticipated start date | 25/03/2007 |
| Anticipated end date | 01/09/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 120 |
| Interventions |
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. |
| Primary outcome measure(s) |
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 measure(s) | Mothers' perception of doing Kangaroo Care during venipuncture was obtained between one and six days after the venipuncture occurred. |
| Sources of funding |
1. Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal)
2. Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal) |
| Trial website | |
| Publications | |
| Contact name | Ms Ananda Fernandes |
| Address | Praceta Falcão Resende, 1, R/Ch |
| City/town | Coimbra |
| Zip/Postcode | 3000-164 |
| Country | Portugal |
| Tel | +351 (0)917 500 541 |
| amfernandes@esenfc.pt | |
| Sponsor | Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal) |
| Address |
Av. Bissaya Barreto
Apartado 55 |
| City/town | Coimbra |
| Zip/Postcode | 3001-901 |
| Country | Portugal |
| Tel | +351 (0)239 487 200 |
| Fax | +351 (0)239 483 378 |
| esenfc@esenfc.pt | |
| Sponsor website: | http://www.esenfc.pt |
| Date applied | 01/10/2009 |
| Last edited | 20/07/2010 |
| Date ISRCTN assigned | 20/07/2010 |
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| © 2010 ISRCTN unless otherwise stated. | |
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