Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202009770590788 Date of Approval: 02/09/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title The Effects of Short Duration Kangaroo Mother Care on Neonatal Pain from Adhesive Tape Removal: A Randomized Controlled Trial Among Preterm Neonates Admitted to Tikur Anbessa Specialized and Gandhi Memorial Hospitals in Addis Ababa, Ethiopia
Official scientific title Kangaroo mother care alleviates neonatal pain from adhesive tape removal: A randomized controlled trial among preterm neonates
Brief summary describing the background and objectives of the trial Studies showed that kangaroo mother care (KMC) has a pain reliving effect for preterm neonates exposed to minor painful clinical procedures. However, since most of the studies were conducted in high income countries using advanced technologies and pain in preterm neonates vary in different settings, the study was planned to determine the pain reliving effects of KMC in Ethiopian context. The main objective of the study was to determine the effects of ten minutes of KMC prior to adhesive tape removal on pain among preterm neonates admitted to Tikur Tikur Anbessa Specialized and Gandhi Memorial Hospitals in Addis Ababa, Ethiopia.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) KMC PIPP
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Supportive care
Anticipated trial start date 01/04/2018
Actual trial start date 01/05/2018
Anticipated date of last follow up 30/06/2018
Actual Last follow-up date 20/08/2018
Anticipated target sample size (number of participants) 160
Actual target sample size (number of participants) 156
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomization Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Kangaroo Mother Care Once Ten minutes before and throughout adhesive tape removal The mother of preterm neonate in need of adhesive tape removal was asked to sit down. Then the neonate who only wore diaper was placed on the bare chest of the mother between her breasts in up right position. His/her legs were placed below the mother's breasts wide opened and flexed. To facilitate breathing, the head of the neonate was slightly extended. To prevent heat loss the back of the neonate was wrapped with additional cloth up to his or her ears levels. Throughout the contact period the mother is allowed to talk or do other activities with her neonate. But she was not allowed to feed the neonate. 78
Control Group Incubator care Till the adhesive tape was removed The adhesive tape was removed while the preterm neonates slept in the incubators. 78 Placebo
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Neonates who were born between 28 and 36 completed weeks of gestation. The gestational age of the neonates was determined by using early ultrasound, Ballard's score or last normal menstrual period Neonates who were not on continuous positive airway pressure or prong oxygen support during the time of data collection Neonates who were not on phototheraphy treatment during data collection Neonates who had mothers who were capable of giving written informed consent and provide kangaroo mother care Neonates who did not need adhesive tape removal Neonates who had visible or diagnosed congenital and neurological anomalies Neonates diagnosed with subgalial and intraventricular hemorrhage Neonates who went through surgery before the time of data collection New born: 0 Day-1 Month 0 Day(s) 28 Day(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 26/01/2018 Addis Ababa University College of Health Sciences School of Public Health research and ethics committee
Ethics Committee Address
Street address City Postal code Country
Churchill Street Addis Abeba 1176 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Pain during adhesive tape removal measured by using premature infant pain profile score 30 seconds after the adhesive tape removal
Secondary Outcome Feasibility of using for neonatal pain management At the end of each data collection
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Tikure Anbessa Specialized Hospital Churchill Street Addis Ababa Ethiopia
Gandhi Memorial Hospital Gambia Street Addis Ababa Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University Eden Street Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa Univerisity Eden Street Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Yemisrach Belete yemisrachbelete@gmail.com +251910659371 Yeka Street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Woldia University
Role Name Email Phone Street address
Public Enquiries Yemisrach Belete yemisrachbelete@gmail.com +251910659371 Yeka Street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Woldia University
Role Name Email Phone Street address
Scientific Enquiries Yemisrach Belete yemisrachbelete@gmail.com +251910659371 Yeka Street
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Woldia University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes All of the individual participant data collected during the trial, after de-identification Informed Consent Form Beginning 3 months and ending 5 years following article publication Investigators whose proposed use of the data has been approved by an independent review committee (“learned intermediary”) identified for this purpose Any purpose Data are available for 5 years at a third party website (Link to be included)
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 31/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 31/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information