The Use of Arnica Montana in the Cicatrization of the Umbilical Cord
Condition: Umbilical Cord Issue
Study type: Observational

Summary: 
      Neonatal infections are still one of the leading causes of mortality among newborns
      worldwide. For example, omphalitis is particularly common and can lead to the development of
      neonatal sepsis. This pathology more frequently affects developing countries, where hygienic
      conditions are often precarious, but the incidence of this disease should not be
      underestimated even in developed countries. Therefore, it is essential to properly care for
      the umbilical stump during the first days of life to prevent infections, both in the hospital
      and at home.

      The complications related to poor hygiene of the umbilical stump can be more or less serious.
      Mild complications include wet stumps, purulent secretions, granulomas, or periumbilical
      erythema. The most serious complications involve infections of the umbilical cord stump which
      can manifest locally or systemically, causing respectively omphalitis or neonatal sepsis.
      Despite the numerous benefits that derive from proper umbilical cord care, the most suitable
      approach remains controversial and several modalities of care have been described.

      The World Health Organization suggests two techniques depending on the neonatal mortality
      rate. In developed countries the use of dry cord care is recommended while in countries with
      a high neonatal mortality rate (>30 deaths/1000 live births) the topical application of
      antiseptics, such as chlorhexidine, is recommended. Recent studies have focused on the
      possible advantages of using natural products of plant origin, whose natural
      anti-inflammatory and dermal protective action is known. Among them, the anti-inflammatory,
      antibacterial and immunomodulatory properties of arnica montana have been studied and it has
      been shown that the use of a powder containing this plant extract reduces parental stress and
      drop time of the umbilical cord stump. However, there is little evidence demonstrating the
      lower rate of mild to moderate complications resulting from umbilical cord stump care with
      this product.
    

Detailed description: 
      Neonatal infections are still an important cause of neonatal deaths, worldwide infections are
      estimated as the cause 4% to 56% of all neonatal deaths. Among the possible points of entry
      for invasive bacteria in neonates, omphalitis represents an important risk factor for
      neonatal sepsis and death. Even if the risk of omphalitis may be greater in countries with
      limited resources and poor hygienic conditions, also in developed countries, where the
      incidence is considered rare, it must not be ignored (0.7%). Consequently, proper umbilical
      cord stump care during the first days of life (both in hospital and at home) shouldn't be
      overlooked to prevent possible complications. The complications of poor hygiene of the
      umbilical cord stump can be serious. Mild complications include wet cord stumps, purulent
      discharge, granulomas, or periumbilical erythema. Severe complications include cord stump
      infections, which may be localized as omphalitis or, after entry in the blood circulation,
      systemic (neonatal sepsis). Despite the known benefits of its correct execution, the care of
      umbilical cord stump remains controversial, and many different approaches are described. The
      World Health Organisation suggests two techniques depending on neonatal mortality rate. In
      developed countries it is recommended the use of dry cord stump care while in countries with
      high neonatal mortality rate (>30 deaths/1000 live births) it is recommended topical
      antiseptics application (such as chlorhexidine). Dry care consists in cleansing the cord
      stump with a neutral soap at birth and then keeping the cord stump dry, avoiding the
      immersion in water. In some centres it is recommended to apply a clean and dry gauze around
      the cord stump or to keep the cord stump outside the diaper. Dry care is an easy and economic
      technique, but parents must be accurately instructed to detect precociously possible signs of
      infection. Topical antiseptics application is recommended in countries where hygienic
      conditions are poor and neonatal mortality rate is higher. However, this practice is often
      widely adopted also in developed countries, where from one side no significant advantages are
      described and on the other side It may increase risk of sensibilization to contact dermatitis
      and burning. A Cochrane review published in 2013 found that the use of medications such as
      chlorhexidine may increase the cord stump separation time, but there is no evidence that it
      increases risk of mortality or infection. In developing countries many other methods are
      used, some of them described in literature: in Africa some mothers apply cow dung and/or oil
      on the umbilical cord stump in Nigeria some women apply mentholated balm or toothpaste on the
      umbilical cord stump; mustard oil and turmeric are used in other regions. These techniques
      are mostly based on cultural traditions and derive both from a lack of healthcare in the
      perinatal period and from ignorance of the population regarding the correct standards of
      care. These methods are not recommended for a demonstrated increased risk of infection by C.
      tetani.The best management of umbilical cord stump care is still unknown. Recent studies
      investigated the use, in addition to dry care, of plant-derived topical products, which are
      known to have natural anti-inflammatory and dermo protective qualities. However, there is
      currently little evidence about their safety and efficacy.
    

Intervention name(s): Cicaben
Intervention type(s): Other
Intervention description(s): Cicaben® powder is an association of special active ingredients for topical dermatological use with a healing, soothing and protective action (zinc oxide, magnesium oxide, corn starch, arnica montana extract, allantoin and undecylenic acid, arginine, glycine and proline, niacinamide).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        They were enrolled infants born in two centers: V. Buzzi Children's Hospital and
        Fatebenefratelli Hospital, ASST-FBF Sacco, Milan, Italy and Ospedale Buon Consiglio
        Fatebenefratelli, Naples, Italy.
      
Keywords: newborn; umbilical cord care; arnica; complications; infections