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.: PACTR202310902873290 Date of Approval: 13/10/2023
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Breast milk application as a natural method for umbilical cord care in Ethiopia
Official scientific title Breast milk application as a natural method for umbilical cord care: a three-arm non-randomized pilot clinical trial in Ethiopia
Brief summary describing the background and objectives of the trial Optimal umbilical cord care is crucial in preventing life-threatening infection and neonatal death. The current standard of care is applying chlorhexidine after a cord cut at birth, but it may be restricted in resource-limited settings. Other methods such as dry alone method (applying nothing) and human breast milk had been used. This study aim to assess the effects of human breast milk compared with chlorhexidine and dry method on umbilical cord separation in Ethiopia.
Type of trial Non-Randomised
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Paediatrics
Sub-Disease(s) or condition(s) being studied umbilical cord care
Purpose of the trial Prevention
Anticipated trial start date 23/03/2020
Actual trial start date 23/09/2020
Anticipated date of last follow up 22/01/2021
Actual Last follow-up date 18/10/2022
Anticipated target sample size (number of participants) 45
Actual target sample size (number of participants) 45
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 Non-randomised Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Own mothers beast milk estimated 1 ml once daily Seven days postpartum Breast milk of own mother expressed and applied on the umbilical cord of neonates two times per day for seven days from Debre Markos Comprehensive Specialized Hospital. 15
Control Group Chlorhexidine gel Approximately 1ml of chlorhexidine gel daily 7 days Control group1 are those Chlorhexidine group from Debre Markos Health center to whom about 1ml of chlorhexidine gel applied daily for seven days. 15 Active-Treatment of Control Group
Control Group Dry care NA NA Dry group participants were only observed without any intervention 15 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton and term pregnancy, and uncomplicated newborns Newborns with complications such as prematurity, low birth weight, congenital anomaly, born by cesarean section or instrumental delivery, and other complications that could risk the newborn. New born: 0 Day-1 Month 1 Day(s) 14 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 14/01/2020 Debre Markos University College of Health Sciences Institutional Research Ethics Review Committee
Ethics Committee Address
Street address City Postal code Country
Debre Markos Debre Markos 269 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Umbilical cord separation time Two times daily for seven consecutive days
Secondary Outcome Umbilical cord infection/omphalitis, neonatal fever, breathing difficulty, neonatal jaundice, breastfeeding difficulty, and persistent crying Two times daily for seven day.
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Debre Markos Comprehensive Specialized Hospital Derbe Markose Kidanemihret Debre Markos Ethiopia
Debre Markos Health Center Debre Markos King Tekilehaimanot Debre Markos Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Debre Markos University Debre Markos Debre Markos City Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Debre Markos University Debre Markos Debre Markos City Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bekalu Kassie Alemu bekalukassiedmu@gmail.com +251920249904 Debre Markos
City Postal code Country Position/Affiliation
Debre Markos City Ethiopia Lecture at Debre Markos University
Role Name Email Phone Street address
Public Enquiries Getnet Gedefaw Azeze gedefawget@gmail.com +251974511882 BDR
City Postal code Country Position/Affiliation
Bahr Dar Ethiopia Lecturer at Injibara University
Role Name Email Phone Street address
Scientific Enquiries Tewachew Muche Liyeh tewye2006@gmail.com +251918475767 DTB
City Postal code Country Position/Affiliation
Debre Tabor Ethiopia Lecturer and head at Debre Tabor University
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual Participant Data of both control and experimental group is available in the corresponding authors on a reasonable request and agreement. Two result summary tables also uploaded. Clinical Study Report IDP is available starting November 2022 Open
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Not online Yes 29/09/2023 31/01/2024
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 07/10/2023
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks Not online
Changes to trial information