Study population and design
Data on the effect of umbilical cord cleansing with a once daily application of CHX (as per the Ethiopian Federal Ministry of Health standard of practice ) and topical HBM once daily were compared with the WHO recommended DCC practice  in terms of cord separation time and rate of cord infection were collected in a three arm, non –masked ,community based cluster randomized controlled trial. This study was conducted at Butajira Demographic and Health Surveillance Site (BDHSS) located in Gurage zone of the Southern Nations, Nationalities and Peoples´ Region (SNNPR) of Ethiopia. The Surveillance System Site consists of 10 kebeles (the smallest governmental administrative unit or sub district) from two woredas (districts) and two zones. Each sub-district has a health post, in which the cluster randomization is based upon. From the 10 sub-districts in BHDSS the 9 sub-districts were included in the study. Then the sub-districts were randomized into three groups; two intervention groups i.e. HBM and CHX group and a control group which is the standard DCC group using a lottery method. Equal numbers of study subjects were assigned to each group. Every procedure was identically conducted for all groups, except for the umbilical cord care. Live born neonates who fulfill the inclusion criteria received either the intervention or the standard care. The primary outcome of the study was cord separation time whereas rate of omphalitis was a secondary outcome. Participants as well as data collectors and supervisors were aware of their study assignment.
Alive singleton neonates who were born between May to November, 2018, and did not have any birth complication which require hospital admission, visited within the first three days after delivery, whose mothers were aged 18 and above (for the purpose of avoiding further requirement of parental consent and legal issues) and who would stay in the catchment area for at least 30 days after giving birth (for follow-up purpose) were eligible for enrollment. Enrolled newborns were visited five times by the data collectors. Data collectors of this study were divided into two groups. The first groups were called the intervention group data collectors. They were trained to visit the newborn on the 1st and 3rd day after delivery. By doing so, they enroll the new born according to the inclusion criteria, obtain an informed consent from the mother, train the mother about how to apply and what procedures to follow when applying the cord care regimens according to the assigned group, council the mother about neonatal and maternal danger signs, signs of cord infection, and to seek for medical care whenever she notices these cord infection and danger signs. The other groups of data collectors were called evaluation data collectors, they collect data regarding demographic, maternal, and newborn characteristics, cord care regimen compliance, applications, and study follow-up, cord separation time in days identifying and recording signs of umbilical cord infection (redness, pus or swelling) on the 4th, 8th and 15th day.
HBM group: for neonate assigned to the HBM group, the mother was trained at two occasion’s i.e. at the first and second time of contact by the intervention data collectors 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 newborn's 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. Mothers were given a picture chart to remind them of the procedure and to apply the intervention every day.
CHX group: neonates assigned to the CHX group, were provided with one tube (20gm) of 4% chlorhexdine gel manufactured by Addis Pharmaceutical Factory PLC, Adigrat, Ethiopia. The mother was trained at two occasions i.e. at the first and second time of contact by the intervention data collectors to wash her hands using soap or ash and water, pierce the sealed mouth of the tube, then expose the newborn's 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 it. Repeat this procedure for seven days once daily. Then, dispose the tube in the toilet after the seventh day. Mothers were told to avoid applying the CHX on the neonate’s eye, ear or mouth. Moreover mothers were given a picture chart to remind them of the procedure and to apply the intervention every day.
DCC group: neonate assigned to the DCC group, were provided with 30 pieces of “ultra- compact cotton buds”. Mothers were trained at two occasions i.e. at the first and second time of contact by the intervention data collectors to wash her hands using soap or ash and water and air dry them. And then expose the newborn's 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. Mothers were given a picture chart to remind them of the procedure and to apply the intervention every day.
In this study cord separation time was defined as the time taken (in completed days) for the full detachment of the umbilical stump from the underlying skin. It was assessed at the home visit on the 4th, 8th and 15th day. The mother’s word and the evaluation data collector’s confirmation were taken as a report of the cord separation time.
Ompalities was defined in this study as infection of the umbilicus in particular the umbilical stump characterized by redness around the umbilicus might extend to the skin of the stomach, swelling , increased temperature of the area surrounding the umbilicus, and pus. It was assessed at the home visit on the 4th, 8th and 15th day by the evaluation data collector’s direct observation of these signs.
The sample size for the trial is driven by the primary outcome of cord separation time mean difference using a study conducted in Iran . By assuming an equal sample size number in each group, two sided 95% confidence interval (CI), and 80% power. Mean difference was calculated between the standard cord care regimen (DCC) and the interventions (CHX or HBM). The final sample size was 337.
Descriptive statistics was used to describe the baseline characteristics of the study participants. Mean and SD were used for the description of continuous data while frequencies and percentages were used for the description of categorical data. The similarity of the baseline characteristics across the groups were compared by ANOVA for continuous variables and Chi square for categorical variables. Intention to treat analysis was used during the analysis of the outcome variable, the study in which subjects were analyzed as part of the group they have been allocated to regardless of whether they comply with the procedures of the intervention or not. Mean CST was compared among the groups using one way ANOVA whereas the secondary outcome i.e. rate of was omphalitis was expressed in terms of frequency and was compared among the groups using Chi square. Level of significance was set at p <0.05 and 95% CI.
Ethical approval was obtained from the school of public health,College of Health science, Addis Ababa University research ethical committee. Separate information sheet was prepared that states the Purpose, benefit, and harm of the study as well as confidentiality and right of participants. After which informed written consent was obtained from the mothers of the newborns during data collection. At the time of enrollment, study participants and their family members were encouraged to contact the data collectors in the unlikely event of any adverse event occurrence. Data collectors were obliged to record and report incidence of adverse events on the separated adverse event reporting form. Moreover they were obliged to advise the mother to seek medical care whenever she notices maternal or newborn danger signs, cord infection and adverse effect of CHX. The right to withdraw from the research process at any point in time was respected. All methods were performed in accordance with the guidelines and regulations of the Declaration of Helsinki.