Condition category
Signs and Symptoms
Date applied
01/10/2009
Date assigned
20/07/2010
Last edited
20/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.esenfc.pt

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

Publication citations

Additional files

Editorial Notes