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.: PACTR202008804462886 Date of Approval: 27/08/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Effect of Topical Application of Human Breast Milk, Chlorhexidine and Dry Cord Care on Neonatal Umbilical Cord Separation Time and Rate of Cord Infection in Butajira, Ethiopia 2017/2018.
Official scientific title Effect of Topical Application of Human Breast Milk, Chlorhexidine and Dry Cord Care on Neonatal Umbilical Cord Separation Time and Rate of Cord Infection in Butajira, Ethiopia 2017/2018.
Brief summary describing the background and objectives of the trial Annually 1 million newborns worldwide die of infection caused by bacteria that enter the body via the umbilical cord. Studies have shown breast milk application to the neonatal umbilical cord has a shorter cord separation time and lower rate of infection. No study was conducted towards the application of breast milk for cord care practice regarding comparison of the standard dry cord care with that of chlorhexidine or human breast milk, in Ethiopia. So, this study intended to measure the effect of topical application of human breast milk, chlorhexidine and dry cord care on neonatal umbilical cord separation time and assess the rate of cord infection at the Demographic and Health Surveillance Site, Butajira, Ethiopia, 2017/18.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Paediatrics
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Prevention
Anticipated trial start date 01/11/2017
Actual trial start date 01/05/2018
Anticipated date of last follow up 30/11/2018
Actual Last follow-up date
Anticipated target sample size (number of participants) 337
Actual target sample size (number of participants) 302
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 Simple randomization using by using procedures such as coin-tossing or dice-rolling 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 Human breast milk 10 drops of human breast milk once daily For seven days Human breast milk intervention: for neonate assigned to the breast milk group, the mother was told to wash her hands using soap or ash and water, and then clean the tip of her breast from inside to outside using a clean wet cloth. Then expose the newborns cord and apply 10 drops of her breast milk and rub it using her index finger on the tip, bottom and body of the cord. Then after, leave the cord without covering it for air dry and wash hands using soap or ash and water. Repeat this procedure for seven days once daily. 106
Experimental Group Chlorhexidine Bean sized chlorhexidine gel once daily for seven days Chlorhexdine intervention: neonates assigned to the chlorhexidine group, were provided with one tube (20gm) of 4% chlorhexdine gel manufactured by Addis Pharmaceutical Factory PLC, Adigrat, Ethiopia. The mother was told to wash her hands using soap or ash and water, pierce the sealed mouth of the tube, then expose the newborns cord and apply a bean sized gel on the index finger then rub the gel on the tip, bottom and body of the cord. Then after, leave the cord without covering it for air dry and wash hands using soap or ash and water. Close the tube tightly and store it in a cool place where children can’t reach at. Repeat this procedure for seven days once daily. 107
Control Group Dry cord care drying the cord once daily using cotton swab for seven days Dry cord care group: neonate assigned to the dry cord care group, were provided with 30 pieces of “Arsan ultra compact cotton buds”. Mothers were told to wash her hands using soap or ash and water and air dry them. And then expose the newborns cord and using two cotton buds dry the cord’s tip, bottom and body. Then after, leave the cord without covering it for air dry and wash hands using soap or ash and water. Repeat this procedure for seven days once daily. 89 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Singleton neonates that did not have any birth complication which require hospital admission; Whose mothers were aged 18 and above (for the purpose of avoiding further requirement of parental consent and legal issues); Who would stay in the catchment area for at least 30 days after giving birth (for follow-up purpose); and Who were willing to provide informed consent. Neonates on whom substances other than the intervention were applied to the cord at the first contact. Neonates who were not visited within three days after birth New born: 0 Day-1 Month 0 Day(s) 3 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 22/02/2018 Addis Ababa University and Research Ethical Committee
Ethics Committee Address
Street address City Postal code Country
AAU Addis Ababa 1000385 Ethiopia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Cord separation time per maternal reported time of the cord separation
Secondary Outcome Cord infection or omphalitis through follow up
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Butajira Demographic and Health surveillance site B15 Butajira Butajira Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Addis Ababa University AAu Addis Ababa Ethiopia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Addis Ababa University AAu Addis Ababa Ethiopia University
COLLABORATORS
Name Street address City Postal code Country
Mr. Abiy Seifu AAu Addis Ababa Ethiopia
Dr. Mulugetgeta Betre AAu Addis Ababa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Melat Mesfin mesfinmelat@yahoo.com +251913846500 AAu
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Postgraduate student
Role Name Email Phone Street address
Public Enquiries Mulugeta Betre mulugeta.betre@aau.edu.et +251942178818 AAU
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Abiy Seifu seifu9@gmail.com +251944070349 AAU
City Postal code Country Position/Affiliation
Addis Ababa Ethiopia Head of Reproductive Health Unit
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Raw data Informed Consent Form 1 month per the requirement of the registry committee and per the approval of Melat Mesfin
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 27/08/2020
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 27/08/2020
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information