Assessment of Chlorhexidine use for cord care at Kangundo level 4 Hospital

Background: Sepsis continues to be an important cause of morbidity and mortality in neonates. One of the most important portals of entry for infections is the umbilical cord. Proper care of the cord can prevent many of these cases of sepsis and hence reduce neonatal mortality rates. In Kenya, the use of chlorhexidine digluconate (CHX) gel was introduced to scale in 2016 and received with mixed reactions in some hospitals with reports of medication errors and ineffectiveness being received. This study sought to find out the knowledge, practices and attitude on its use in Kangundo Level 4 hospital. Methodology: The study was carried out at Kangundo level 4 hospital between June and August 2019. It was a descriptive cross-sectional study with both quantitative and qualitative components. A questionnaire was used for the quantitative data collection while focus group discussions were held for the qualitative data collection. Ethical approval was sought prior to commencement of data collection. Results: A total of 19 clients and 24 healthcare workers were interviewed and two focus group discussions held. All the 19 clients had delivered in the hospital and only three were first-time mothers. Education on how to use chlorhexidine (CHX) was given to 16/19 (84%) of the clients interviewed. Duration of application varied among clients; 4 days 5/19(26%), 7 days, 12/19 (64%) and until the stump falls off, 2/19 (10%). Twenty of the 24 HCWs (83%) interviewed advised the patients on cleaning the cord prior to application of CHX, frequency of application varied from OD 15/24 ( 62%), BD 3/24 (13%) and TID 6/24( 25%). Two FGDs were held for HCW; lack of training and clear instructions on how to use the gel as major contributors to ineffectiveness of CHX.

3 Conclusion and recommendation: There was poor understanding on the use of CHX among both clients and HCWs at Kangundo level 4 hospital. Cleaning of the stump prior to gel application is important to prevent accumulation of the dry gel and allow contact with the wound. There is need for training and development of a standard operating procedure on use of CHX.

Background
The rate of neonatal mortality globally stands at 22 deaths per 1000 live births and 41 % of the deaths in children occur during the neonatal period (1) . The main causes of neonatal deaths include preterm birth, asyphixia, pneumonia,neonatal tetanus, diarrhea and sepsis (1). Approximately 460 000 infants die annually in the developing world because of bacterial infections, of which umbilical cord infections are an important precursor (2). Umbilical cord infections have much higher incidence rates 55-197 per 1000 live births. Children born in low-income countries are 14 times more likely to die before their fifth birthday as those born in high income countries (3).
Sepsis continues to be a formidable problem in neonatal care settings in the world and in Kenya. According to Kenyan statistics, neonatal deaths stood at 22 deaths per 1000 live births with 60% of infant deaths occurring in the first year of birth (4).
Neonatal deaths account for almost one-third of deaths in children under five years in Kenya. In a study carried out Kilifi District Hospital, Kenya, neonatal deaths comprised close to 60% of all the inpatient deaths in hospitalized children (5). In Kangundo hospital, data shows that sepsis was responsible for 34% of hospital admissions in the newborn unit and caused 15% neonatal deaths in 2018. 4 Good umbilical cord care is important in decreasing the incidence of omphalitis and neonatal tetanus (6)  The umbilical cord connects the baby and the placenta while in the womb. It is made of blood vessels and connective tissue cells and immersed in amniotic fluid.
The umbilical cord is covered by amnion which is continuous with the outer epithelial layer of the embryo at the attachment of the umbilicus(10). After delivery, the umbilical cord is cut separating the mother and her baby. This leaves behind a stump that is expected to dry, fall off leading to the healing of the wound.
This open wound can sometimes be a portal of entry for pathogenic micro-organisms that can cause infection at the site or in the blood stream ( septicemia). It is therefore paramount that the cord stump be kept clean. Sources of the pathogens could be the mother's birth canal, the care giver's hands or the environment where the new born is (11). The umbilical stump is therefore an important portal of entry of microorganisms that can lead to morbidity and mortality.

Neonatal mortality rates
It is estimated that about 3.3 million deaths occur in neonates annually (3) and more than 30% of these are caused by infections (12

Cord care practices
When cord care is inadequate, infections can occur locally at the cord stump (omphalitis) or in the blood stream. The umbilicus provides direct access to the blood stream and is fertile ground for bacterial growth (15). Infections of the cord are preventable in most cases and the best practices should be employed to prevent neonatal morbidity and mortality. Many practices have been used to ensure that the cord remains aseptic and free of infections. However, it has not been concluded which practice is superior to others in most cases (7). Most commonly used methods include use of antiseptics such as alcohol, iodine, silver sulphadiazine, chlorhexidine and dyes. Use of antibiotics such as tetracycline, bacitracin, neomycin and nitrofurazone has been advocated for in some countries. Other studies have shown that natural drying of the cord is more effective than use of alcohol (16)and had a shorter cord separation period. A study done in France showed that dry cord care was non-inferior to use of antiseptics and should be used instead of antiseptics 8 which were unnecessary, expensive and constraining in high income countries (17).
The world health organization recommends the use of topical antiseptics (chlorhexidine) where hygienic conditions are poor and or infection rates are high (18).
A systematic review of studies on umbilical cord care practices conducted in 1999 found no significant difference in the effectiveness of different methods (6).
However, some products such as chlorhexidine showed increased separation time with reduced bacterial colonization but there was no change in infection rates. A randomized controlled trial comparing the use of sterile water and sterile alcohol and found no difference in bacterial colonization of the umbilical cord (19). In a randomized control trial done in India in 2011, CHX was found to be superior to dry cord care by significantly reducing the amount of blood-culture confirmed sepsis and having a shorter separation time (20). A recent systematic review showed that use of CHX was beneficial in reducing neonatal morbidity and mortality in infants born at home but there was no evidence of the benefit of CHX over dry cord care for infants born in hospitals (11). It recommended the use of CHX for all births in Kenya to ensure an all-inclusive policy in the country.

Study design and study site
The study was a descriptive cross-sectional study with both qualitative and quantitative components. The quantitative section involved data collection using a pre-developed questionnaire while the qualitative section involved collection of views of health care workers through a focused group discussion (FGD. The study was conducted at the Kangundo level 4 hospital in the months of July and August 2019. The target population were healthcare workers working in maternity, postnatal ward, newborn unit (NBU) and maternal and child health unit (MCH).It also targeted clients targeted who were in postnatal ward or mothers to neonates visiting the MCH. Census was used as the sampling technique to determine the number of healthcare workers and clients to be interviewed. All nurses working in the departments mentioned above were included in the study. All clients in the postnatal ward on the day of data collection will be included in the study. All clients visiting the MCH department with neonates were included in the study. The focused group discussion had two representatives from each department.

Data Collection and Analysis
Quantitative data was collected was collected using the developed questionnaire.
The questionnaires were fed into a excel spreadsheet, collated, then stored in a password protected computer for cleaning. Prior to analysis, quantitative data was exported to MS Excel then later exported to SPSS for analysis. Data analysis was carried out using univariate analysis techniques. This will involve frequency distributions for categorical variables and descriptive statistics (means, medians, standard deviations) for continuous variables. Categorical variables (e.g. uptake of CHX, etc.) will be presented using bar charts, pie charts and frequency distribution tables. Box plot will be used to present continuous variables. Univariate analysis was used to determine the prevalence of CHX use and to give an understanding of the characteristics of the study participants. Statistical Package for Social Sciences (SPSS) version 20.0, will be used for data analysis while MS Excel will be used to create charts and graphs.
Qualitative data was collected through focus group discussions which were audio recorded, transcribed, and analyzed for themes and patterns. Descriptive analysis of the sample was then conducted. The process was used to develop themes and sub-themes that emergde from the ground based on responses to the questions.
Data presentation will be through verbatim.

.3 Ethical consideration
Ethical approval was sought from the Mount Kenya University ethics review committee (ERC) before commencement of the study.(number). Informed consent was sought from health care workers and clients before data collection was done.
All data was captured anonymously and no data bore direct personal identifiers.
Consent to publish was sought from the co-authors.

results
A total of 19 clients and 24 healthcare workers were interviewed and two focus group discussions held.

Figure3: Comparative Effectiveness of CHX with Methylated spirit by HCWs
Two FGDs were held for HCW; lack of training and clear instructions on how to use the gel were the major contributors to ineffectiveness of CHX. Most of the participants in the FGD felt that methylated spirit was more effective than CHX. Gel was not applied immediately after birth in maternity as recommended. There was no clear direction on whether the cord was to be cleaned before application. Those who opted to clean either used saline water or just warm water. There was erratic supply of the gel ,leading to reverting to use of methylated spirit.
I do not like using the chlorhexidine gel as it forms a dry coat on the cord that is not easy to clean. I tell mothers to clean using methylated spirit, which we provide in the ward. Sometimes the CHX gel is not available.
We were using the CHX gel for some time until it ran out of stock and we reverted to 13 use of methylated spirit. The stumps were falling off when some patients were still in the ward. It was like magic!
The supply is so erratic and sometimes they supply the gel and sometimes the drops. The drops were better since they do not form a coat around the stump. The product is out of stock most of the time and its not stocked in local chemists where the mother can purchase. We keep going back to use methylated spirit.
Training on use of CHX No training Guidelines were provided but most HCWs

Use of CHX
No standard way of using CHX.

Instructions given to the mothers on use of CHX
To clean the stump using cotton wool soak Apply CHX once daily for seven days In a study comparing use of various antiseptics and water for cord care in developed countries, found that use of water had a shorter cord-separation time than alcohol. There was therefore no advantage of using antiseptic in developed countries. However, the study recommends use of antiseptics in certain situations where there is a high risk of infections such as in pre-term babies, babies in intensive care units and in institutions in developing countries such as ours (23).

Instructions in the guideline and product insert
Recommendations by a study that supported the scale up of CHX use have not been fully implemented; These include community sensitization through CHVs, staff training, providing CHX for free and ensuring constant supply of the medication (22).
The scale-up of CHX use has been met with reports of medication errors some of which led to adverse drug reactions. Most of the reported ADRs were associated with a particular formulation-the drops that were confused for eye-drops. The pharmacy and poisons board conducted investigations on the allegations(9) and later issued a circular to market authorization holders directing how packaging of the product should be done for marketing in the country (24).
A study done in a referral hospital in India comparing the effect of CHX versus dry cord care showed a significant difference in time to separation with the CHX showing a separation time of 9 days versus 10 days with the dry cord care. There were no micro-organisms isolated on culture in the CHX group compared to several micro-organisms (Acinetobacter, Enterococcus,Klebsiella and Stapyllococcus)) that were isolated in the dry cord care group. The neonates treated with dry cord care were ten times more likely to get sepsis as compared to those treated with CHX (20).
A study conducted in Ibadan, Nigeria to compare the incidence of umblical cord infections among neonates receiving CHX gel and methylated spirit found no significant difference (25). However, this study found a higher non-compliance incidence in the group receiving CHX. Mothers had to use other products to clean the cord due to the dry flakes left by the gel.
I conclusion, studies done in many countries have not shown therapeutic superiority of CHX over other products or dry cord care. However, it is recommended that CHX be use in situations where infections of the cord are likely to happen if dry cord care is practiced. The product recommended for use in Kenya is CHX. However, there needs to be clear standard operating procedures on the use of chlorhexidine gel for cord care in order to achieve its maximum therapeutic benefits. declarations

Competing interests
Authors declare no competing interests

Authors contributions
Clarice Ambale participated in proposal development, data collection and analysis,  Figure 1 Comparative Effectiveness of CHX with Methylated spirit by clients Twenty of the 24 HCWs (8 20 Figure 1 Comparative Effectiveness of CHX with Methylated spirit by clients Twenty of the 24 HCWs (8 Figure 2 Duration mother advised to use CHX gel 21 Figure 2 Duration mother advised to use CHX gel Comparative Effectiveness of CHX with Methylated spirit by HCWs Two FGDs were held for HC 22 Figure 3 Comparative Effectiveness of CHX with Methylated spirit by HCWs Two FGDs were held for HC