Contact information
Type
Scientific
Primary contact
Ms Ananda Fernandes
ORCID ID
Contact details
Praceta Falcão Resende
1
R/Ch
Coimbra
3000-164
Portugal
+351 (0)917 500 541
amfernandes@esenfc.pt
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
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
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 trial start date
25/03/2007
Overall trial end date
01/09/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Gestational age between 28 and 36 weeks
2. Postnatal age less than 28 days
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
120
Participant 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
Recruitment start date
25/03/2007
Recruitment end date
01/09/2008
Locations
Countries of recruitment
Portugal
Trial participating centre
Praceta Falcão Resende, 1, R/Ch
Coimbra
3000-164
Portugal
Sponsor information
Organisation
Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
Sponsor details
Av. Bissaya Barreto
Apartado 55
Coimbra
3001-901
Portugal
+351 (0)239 487 200
esenfc@esenfc.pt
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal)
Alternative name(s)
Portuguese Science and Technology Foundation, Foundation for Science and Technology, FCT
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
Portugal
Funder name
Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary