An Investigation into the use of cord treatments on the newborns umbilical cord and the reduction of infection.

A LITERATURE REVIEW.

Kathrine Hill Student Health Visitor.

Bolton University. 2014.

Word count: 3720.

An investigation into the use of cord treatments on the new-borns umbilical cord and the reduction of infection. A Literature Review.

INTRODUCTION.
The purpose of this literature review is to examine the evidence surrounding umbilical cord care in the new-born and what part the use of topical treatments play (if any) in the reduction of infection to the new-born infant.
The umbilical cord is a unique tissue consisting of two arteries and one vein. Wharton’s jelly surrounds the vessels. During pregnancy the umbilical cord assists the placenta by transporting nutrients and waste products to and from the fetus. (Fraser, M. et al 2009). Following delivery of the neonate the cord goes through a process were it dries out, hardens and turns black. The area goes through a process of colonization due to non-pathogenic organisms that pass from mum to baby via skin to skin contact following delivery. The umbilical vessels remain patent for several days following birth and are a susceptible site for infection. Potentially harmful organisms can be spread by cross infection, often caused by poor hand washing techniques of Healthcare workers and the infant’s carers. (Davies, S. 2008).
The World Health Organisation (WHO) reports each year one third of neonatal deaths worldwide (1.5 Million) are due to infection, many of which begin as umbilical cord infection. (Cappuro, H. 2004). Current guidelines for umbilical cord care differ enormously from country to country and establishment to establishment, and most of the current literature surrounding umbilical cord practices indicates practice is based on historical assumptions rather than research evidence. (Tammy, P et al 2004). Documented historical practice of cord care includes coins, plant extracts, raisins, olive oil, coconut oil and colostrum. (Perrone, S et al 2012 and Karumbi et al 2013). Methods currently used for umbilical cord care include triple dye, alcohol, antibiotic ointments/powders, betadine, soap and water and no treatments at all. (Tammy, P. et al 2004).
Following the findings of a COCHRANE review by Zupan and colleagues the WHO made recommendations that include aseptic techniques involving health professionals and hand washing. The use of sharp sterile instruments to cut the cord at birth. Leaving the stump 2-3cms long and placing it outside the nappy area to promote drying. (Perrone, S. et al 2012). However these findings apply primarily to high income countries and hospital settings and so pose the question about treatment in poor income countries and community settings. Current guidelines from the National Institute of Clinical Excellence (NICE 2006) apply to practice undertaken by Health Professionals in the United Kingdom (UK), and have implemented the recommendations from the WHO with regards to dry cord care in the new-born. However with the ever changing climate, increasing poverty and more family’s living below the bread line in the UK, Health Professionals and in particular Health Visitors, will encounter family’s living in unhygienic conditions and are in an optimum position to educate and implement practices that may help reduce infection in their children. Health Visitors need to offer help and advice based on Evidence Based Practice (EBM). With reference to this, the PICO process was applied to formulate a question, thus highlighting the need for this literature review. (PICO 2008).

METHODS.
Aveyard (2010) defines a literature review as “a comprehensive study and interpretation of literature that relates to a particular topic.” For Health Visitors there is an increasing importance related to Evidence Based Practice (EBM) and its relevance in everyday practice. Health Visitors have a duty of care to be up to date with research and development in their field of work, as stipulated by their Governing Body The Nursing and Midwifery Council. (NMC 2010). Literature reviews bring together evidence, systematically review them and bring together the results so they can be viewed as a whole. Aveyard (2010).
A systematic review of literature was performed to identify the existing knowledge base of current practice surrounding umbilical cord care. A search of 5 databases, Pro Quest, Scopus, CINAHL, Cochrane and Medline were undertaken. These databases were specifically chosen as their contents include abstracts, indexes and evidence that can help to inform and develop practice for Health Professionals. The search was commenced using the word “umbilical cord”. This produced a vast amount of literature, so the words “cord care”, “new-born”, and “cord powder”, were introduced to the search. These words also produced a mass of literature some relevant and some not. Due to time restrictions the search was refined and an inclusion and exclusion criteria was applied to the literature search. (table 1).

Table 1. INCLUSION CRITERIA | REASON FOR INCLUSION. | EXCLUSION CRITERIA | REASON FOR EXCLUSION | Literature from 2000-2014. | Relevant and up to date. | Literature before 2000. | Dated Literature. | Abstract relevant to question posed. | Identify relevant papers. | Preterm Infants. | Nursed differently from term baby’s, encounter more interventions. | Term infants. | Relevant to practice. | Literature not readily available. | Time constraints. | English Language papers. | Unable to translate other papers due to time constraints. | | |
The initial search using the key word “umbilical cord” highlighted 1427 papers in CINAHL, 848 in Cochrane, 745 in Medline, 390 in Pro Quest and 17,672 in Scopus. The search was then refined, specifying dates of publication. CINAHL revealed 42 papers following revision, on closer inspection of the abstracts this revealed the majority of these were not relevant and 4 were selected. Cochrane generated 12 hits, 4 of which were relevant.
Scopus, Medline and Pro Quest continued to generate vast amounts of literature, 4122 results from Scopus, 479 from Medline and 64 for Pro Quest. Refining the search terms further by limiting papers to the other inclusion and exclusion criteria in table 1 rectified this and the results following the modifications revealed 5 relevant articles from Medline, 8 from Pro Quest and 11 in Scopus. (appendix 1).

Following the literature search 32 papers were selected. However on closer inspection 9 of the papers were replicated in some of the search databases. A further 19 papers were not readily available and due to time constraints were rejected. The 4 remaining papers were looked at again, in particular the references used in the papers to observe if any literature had been overlooked in the search. This “snowballing” revealed 2 more papers of which 1 was deemed relevant. In total 5 pieces of work were chosen for literature review.
The 5 pieces of literature were chosen following implementation of the Critical Appraisal Tool CASP (Critical Appraisal Skills Programme). CASP uses a systematic process of questions to review chosen literature and appraise its strengths and weaknesses. Using the CASP tool, the literature was scrutinised and specific areas of the literature were looked at in more depth. Type of research/ study size/ approach used /recruitment methods/ criteria eligibility/ population studied/drop outs/limitations/characteristics of study/emerging themes. Following this process all literature identified consisted of Quantitative studies. 4 of the Quantitative studies had used Randomised Control Trials in their methodology, and the remaining piece of literature a Large Longitudinal Cohort Study. Each piece of literature was linked within the hierarchy of evidence and categorised. (appendix 2).
The proposed question is directly trying to ascertain if any topical treatment would be of benefit to new-born infants. Quantitative research Studies lend themselves to the question posed as they involve many participants and the findings can often be applied in other contexts. Aveyard. (2010). Randomised control trials are seen as the gold standard of clinical trials and are often used to test efficacy or effectiveness of types of medical interventions. From the trials, often a recommendation can be made which in turn would impact on Health Professionals practice. From the literature selected themes were identified in the text, and explored in more detail. Table 2 indicates the themes identified in the literature. Due to time constraints the 4 most common themes were identified. Cord Separation Time, Mode of delivery, Adverse Effects and Parental Satisfaction. These themes were then looked at in more detail, to determine if they could answer the research question.

TABLE 2.

CORD SEPERATION TIME.
When trying to determine the most effective treatment to reduce the risk of infection in the new-born, cord separation time (CST) was a common theme identified in all the literature selected. As highlighted earlier the umbilical cord stump provides direct access whilst still attached, to the bloodstream of the new-born, hence the longer it takes to separate, increases the risk of infection to the new-born.
Kapellen et al (2009) conducted a RCT comparing dry cord care and the use of chlorhexidine (CX) powder. The results from the trial identified that the use of CX powder accelerated the separation of the umbilical cord, compared to dry cord care (no treatment). Kapellen et al (2009) also go on to state that cord separation time can be influenced by the use of antimicrobial agents. Only one form of antimicrobial agent was used in this trial and the authors have made generalised assumptions with regards to other types of antimicrobial agents and the influence they can have on cord separation time. The study was financially supported by Riesmser Arzneimittelwerke AG, who are a Pharmaceutical Company which could be viewed as a bias towards the use of antimicrobial treatments that they produce. A study carried out by Pezzati et al (2002) also identified a shorter separation time of the umbilical cord with the use of CX powder and link this to the importance of dehydrating effects on the umbilical cord. However in this study, CX was also used in liquid form and reported that it could prolong cord separation when used in this form. The authors emphasise the importance of dehydrating the cord and separation time. The study goes on to report that dry cord care, Salicylic sugar powder and Green clay powder were the most effective treatments when compared to the five other regimes included in their study. The literature identified that there were compliance issues with some of the other interventions randomised to the new-borns, however there is no evidence in the literature that suggests the data connected to the non-compliance was disregarded and therefore a bias of results cannot be ruled out.
Mullany et al (2013) and Soofi et al (2012) indicated from the studies they carried out that cord separation time tends to be longer with the use of antimicrobial interventions compared to dry cord care. These pieces of literature contradict the findings of Kapellan et al (2009) and Pezzati et al (2002). Mullany (2013) goes on to stress the importance of recognition of the need for different regimes of cord care in different communities, and even though a statistical significant increase was observed with regards to CST and dry cord care in their study, the author goes on to report this may not be appropriate treatment in high risk, low-resource communities. Soofi et al’s (2012) trial also supports this statement, however on closer inspection of their results, it is apparent they have dismissed cord separation time (CST). The results demonstrate that the dry cord regime compared to the 3 different treatment regimes resulted in CST of 1-2 days before the 3 other regimes. Soofi et al (2012) go on to report there was no difference in the CST between the 4 groups, which highlights inconsistencies in their analysis of results.
Perrone et al (2012) looked at a very different forms of treatment compared to the other trials selected. The results of CST with the use of Arnica Echinacea to treat the umbilical cord were favourable and the authors report a recommendation that it be introduced as a routine powder for new-born umbilical cord care, due to its low cost, acceleration of cord detachment and feasibility. The trial does not demonstrate if any long term effects were identified with the use of Arnica Echinacea on the new-born infant and there is no evidence of the study being approved by an ethics committee hence the safety of the trial could be questioned. The trial also made no attempt to use a placebo within the methodology and so the results identified may not be as feasible as portrayed by the authors.

MODE OF DELIVERY.
Three of the pieces of literature identified that the mode of delivery of the new-born could have an impact on cord separation and infection. Pezzati et al (2002) identify strict exclusion criteria in their methodology and go on to highlight areas for example gestational age, sex of new-born and mode of delivery as aspects that could possibly impact on their results. These epidemiological characteristics are not translated into the results and therefore questions need to be asked as to why they were disregarded as it is not clear.
Perrone et al (2012) also recognise that there may be significance with regards to mode of delivery. In their research they also make references to vaginal and caesarean births and the possible effects it can have with regards to infection. Despite these measures being recognised by the authors, they have failed to incorporate them into their findings and results. Therefore it is difficult to ascertain if the inclusion of these would have impacted on the results as a whole.
Following analysis of findings, Kappellen et al (2009) identified that new-borns delivered by caesarean section have a longer cord separation time due to bacterial colonization compared to new-borns by vaginal delivery. The randomization in this trial was stratified because of the expected differences of CST in the 2 groups. The literature does not identify why there was an expectation on the author’s part, however the results demonstrate a statistically significant (p<0.0001) difference between the two.
When looking at mode of delivery all the authors failed to look at the difference in length of stay in hospital with regards to mode of delivery. A longer stay in hospital as encountered by ladies undergoing caesarean deliveries, may impact on the findings, due to cleanliness, hand washing and adherence to regimes in a hospital setting.

ADVERSE EFFECTS.
As stated previously the WHO report that 1.5 million of neonatal deaths each year are due to infection. The emphasis and emerging theme in all the literature reviewed is linked to infection and adverse effects for example inflammation, bleeding, cellulitis, pus and offensive smell. The literature selected is from an array of socio economic settings, high and low risk communities and differing cultural values
Soofi et al (2012) primarily wanted to look at the risk of the new-born developing the infection Omphalitis. The randomised cluster trial was undertaken in Dadu and recruited 9741 new-borns. 4 different regimes were allocated to the new-borns. The authors wanted to demonstrate the effectiveness of Chlorhexidine in reducing Omphalitis. The results indicate that the use of Chlorhexidine on the new-borns umbilical cord can reduce the incidence of Omphalitis compared with dry cord care. Closer inspection of the literature reveals some inconsistencies. Fewer participants than estimated in one of the groups were identified due to problems with accessing them, the authors have acknowledged this but do not advise if this had an effect on their results. They also go on to state that no reliable information exists with regards to the population chosen and new-born omphalitis rates and devised their own baseline to make comparisons to. As there is no indication in the literature of approval from any board, it poses the question how ethical is the study.
The recognition of new-born omphalitis is an important factor in the literature. Community Health Workers (CHW) plays an important role in identifying and collecting results. Both Soofi et al (2012) and Mullany et al (2013) used CHW’s to gather relevant data. Soofi et al (2012) identified that questions could be asked of the diagnosis of omphalitis by the CHW’s as only limited training and supervision on the specific area had been undertaken. Mullany et al (2013) make no reference to training undertaken by the CHW’s if any at all and so could indicate limitations in the results, similar to those of Soofi et al. (2012).
Kapellen et al (2009) in their findings report a significant increase in adverse effects when dry cord care is implemented. They go on to report none of the adverse effects were serious. As previously identified this study was funded by a pharmaceutical company that produce antimicrobial products. The authors do advise that an observer bias cannot be excluded due to the nature of treatment versus no treatment, they do not indicate if a bias towards treatment was eradicated due to the nature of the funding.
Both Pezzati et al (2002) and Kapellan et al (2009) identify no difference in Omphalitis rates in treatment and non-treatment groups. Both however go on to make recommendations of the use of an intervention on the umbilical cord, as it is “superior” to dry cord care. Pezzati et al (2002) furthermore goes on to report that there is no evidence to confirm that dry cord care is harmful. This statement contradicts the recommendations made by the authors and thus makes the results appear incoherent.
No cases of Omphalitis were reported by Perrone et al (2012) in their trial. A small percentage of bleeding was noted, but was not classed as an adverse effect unlike the other pieces of literature. The results from this trial reported positive results with regards to cord separation time and adverse effects. A large cohort of 6323 new-borns were treated with Arnica Echinacea. Prior to treatment the cord was cleaned and imbued with peroxide hydrogen. The authors do not indicate if this intervention prior to treatment could have impacted on the results and no other literature selected employed this method, so its impact needs to be questioned. This study is also the first of its kind to use Arnica Echinacea and so highlights further research is needed with regards to this treatment, before recommendations of its use can be made.

PARENTAL SATISFACTION.
Parental Satisfaction was identified in four of the chosen pieces of Literature. As parents have ultimate responsibility for caring for their new-borns any form of care or intervention has to be accepted by them for it to be successful.
Pezzati et al (2002), demonstrates that the parents recruited to their trial were anxious with regards to not using any form of treatment on the umbilical cord. They go on to report that a short cord separation time was desirable for parents. Some of the treatments in this trial were deemed unacceptable by the parents, due to the nature of how they looked and that some treatments were new. These findings could impact on compliance and adherence with the treatment randomised to them. Mullany et al (2013), also identifies the importance of parents satisfaction with treatment. They identify that it is also of great importance to educate parents on topical treatments, and the need for concordance for them to be effective. Inadequate knowledge with regards to the pros and cons of the different treatments was identified by the authors in this study and the importance of communicating signs of infection, CST and normal appearance of the umbilical cord were identified as best practice.
Both Perrone et al (2012) and Kapellan et al (2009) indicate that no apprehension was identified within their treatments groups. Both go on to identify that the parental participants would go on to administer their chosen treatments to their next child. Only one form of treatment was employed in Perrone et al (2012) trial and so it is difficult to determine if parents would have been just as happy with no treatment, as no comparisons can be made.

CONCLUSION.
The literature surrounding care of the new-borns umbilical cord is vast. However this literature review has highlighted much of the literature is dated. It is clear from the findings that current practice is very much determined by the high/low income of the country. Tammy et al (2004) also identified historical practices and traditions were implemented rather than scientific investigation and justifications. In low income country’s were neonatal mortality and infection rates are high the literature supports the use of antimicrobials on the new-borns umbilical cord, this however may prolong cord separation time which has shown to cause anxiety in caregivers. Mullany et al (2013) emphasise the importance of education and communication in low income settings to help aide compliance with treatments. These findings have implications for Public Health in low income countries, as indicated by Soofi et al (2012), were many areas share similar cultural, social and economic characteristics.
The recommendations for high income countries appear unclear. The WHO (1998) recommend dry cord care, however it is clear from the literature critiqued that antimicrobial powders and liquids are being used in these settings along with some alternative therapies, despite the WHO recommendations. No clear reasoning for the use of interventions have been identified in the literature searched, and dry cord care versus interventions revealed negligible differences, which could raise the question why incur the cost of treatments if they are not necessary.
Health Visitors are ideally placed to promote health and educate parents on the care of their new-borns. The 4 principles of health visiting as defined by the Council for the Education and Training of Health Visitors (CETHV) overlap and are inter-related with regards to Promoting health and put Health Visitors at the forefront of the public health agenda. (Unite/CHPVA 2007). It is imperative that the advice they give is based on evidence, as this is viewed as gold standard of care. All the literature critiqued highlighted the lack of knowledge of caregivers surrounding umbilical cord care. The literature demonstrated that additional research is required in this area to provide an evidence base for practice. More research looking at natural healing of the umbilical cord and the education of caregivers in high income countries is required to achieve an accurate evidence base.

APPENDIX 1. DATABASE. | SEARCH TERM USED. | NUMBER OF HITS. | NUMBER RELEVANT TO SEARCH. | NUMBER SELECTED FOR FURTHER ANALYSIS. | CINAHLADVANCED SEARCH | UMBILICAL CORD,NEWBORN INFANT,UMBILICAL CORD INTERVENTIONS. | 4 HITS | 4 RELEVANT ARTICLES. | 2 SELECTED, 2 UNAVAILABLE. | COCHRANE | UMBILICAL CORD, NEWBORN INFANT,UMBILICAL CORD INTERVENTIONS,UMBILICAL CORD POWDERS. | 12 HITS + 9 TRIALS | 9 RELEVANT ARTICLES. | 1 SELECTED, 7 UNAVAILABLE,1 REPEATED FROM CINAHL. | MEDLINE | UMBILICAL CORD CARE, NEWBORN INFANTS. | 16 HITS | 6 RELEVANT ARTICLES. | 5 UNAVAILABLE,1 REPEATED FROM CINAHL. | PRO QUEST | UMBILICAL CORD,NEWBORN INFANT,CORD CARE. | 64 HITS | 8 RELEVANT ARTICLES. | 1 SELECTED, 2 REPEATED FROM CINAHL, 5 UNAVAILABLE. |

APPENDIX 2.

AUTHOR(S) /DATE. | TYPE OF STUDY. | HIERACHY OF EVIDENCE. | GRADING. | Pezzati, M. et al. 2002. | Randomised Control Trial. | 1- | A | Kapellen, T M. et al. 2009. | Randomised (Two Armed Control Trial. | 1- | A | Soofi, S et al. 2012. | Cluster Randomised Control Trial. | 1+ | A | Mullany, L C. et al. 2013. | Cluster Randomised Control Trial. | 1- | A | Perrone, S et al. 2012 | Cohort Study. | 2- | B |

ARTICLES SELECTED FOR LITERATURE REVIEW. Author(s)/Date | Title/Aim(s). | Type of Study. | Main Findings/Themes of study. | Strengths. | Weaknesses. | Pezzati, M . et al. 2002. | Umbilical cord care: The effect of eight different cord-care regimes on cord separation time and other outcomes. | Quantitative Study.Randomised Control Trial. | Cord separation time.Adverse Effects.Parental Satisfaction. | All infants were exposed to the same regime on admission to the ward, before starting randomised intervention. | Randomisation was allocated to one of regime of 8 for the month, thus the trial not being blind. | Kapellen, T M. et al. 2009. | Higher rate of adverse cord-related adverse events in neonates with dry umbilical cord care compared to Chlorhexidine powder. | Quantitative Study.Randomised (Two Armed) Control Trial. | Cord Separation Time.Mode of Delivery.Adverse Events.Parental Satisfaction. | Stringent Inclusion criteria. | No blinding was possible due to treatment versus no treatment.Caregivers were reporting on adverse effects, which could differ as no indication in research with regards to education of complications. | Soofi, S. et al. 2012. | Topical application of Chlorhexidine to neonatal umbilical cords for prevention of omphalitis and neonatal mortality in a rural district of Pakistan. | QuantitativeStudy.Cluster Randomised Control Trial. | Infection and adverse effects.Cord Separation Time.Home v Hospital Delivery. | Randomisation of intervention was coded, by a computer-generated random sequence.3 day training programme implemented for professionals involved in the study, to ensure a standard of practice across the study. | Concerns raised with regards to diagnosis of infection by non-medical trained carers.Further traditional interventions introduced by parents( not excluded from trial) | Mullany, L C. et al. 2013 | Chlorhexidine cleansing of the umbilical cord and separation time. | Quantitative Study.Cluster Randomised Control Trial. | Cord Separation Time.Adverse Effects.Parental Satisfaction.Hand Washing. | Large participant numbers. | Compliance problems with participants. | Perrone, S. et al 2012 | Efficacy of Arnica Echinacea powder in umbilical cord care in a large cohort study. | Quantitative Study.Cohort Study. | Cord Separation Time.Adverse Effects.Parental Satisfaction. | Low cost Intervention. | No Placebo. | |

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