Kangaroo mother care combined with sucrose to reduce pain responses in preterm infants

ISRCTN	ISRCTN73259137
DOI	https://doi.org/10.1186/ISRCTN73259137
Protocol serial number	N/A
Sponsor	Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)
Funders	Foundation for Science and Technology (Fundação para a Ciência e a Tecnologia [FCT]) (Portugal), Nursing School of Coimbra (Escola Superior de Enfermagem de Coimbra) (Portugal)

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

Praceta Falcão Resende, 1, R/Ch
Coimbra
3000-164
Portugal

Phone	+351 (0)917 500 541
Email	amfernandes@esenfc.pt

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled clinical trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(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).
Key secondary outcome measure(s)	Mothers' perception of doing Kangaroo Care during venipuncture was obtained between one and six days after the venipuncture occurred.
Completion date	01/09/2008

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes