The Use of Arnica Montana in the Cicatrization of the Umbilical Cord

NCT ID: NCT05958251

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 326 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-05-30
• Study Completion Date: 2022-11-02

Brief 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.

Conditions

Umbilical Cord Issue

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cicaben

Umbilical cord stump of the newborns was medicated by Cicaben ® (Orsana S.r.l.), a natural topical dermo-protective powder

Cicaben

Intervention Type: OTHER

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).

Standard dry care

Umbilical cord stump of the newborns was medicated by standard dry care

Standard Care (in control arm)

Intervention Type: OTHER

Standard care

Interventions

Cicaben

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).

Intervention Type: OTHER

Standard Care (in control arm)

Standard care

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Gestational age > 35 weeks and hospitalization in Standard Neonatal Care.

Exclusion Criteria

• They were excluded newborns admitted in Neonatal Intensive Care Unit.

• Minimum Eligible Age: 35 Weeks
• Maximum Eligible Age: 42 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ospedale Buon Consiglio Fatebenefratelli

OTHER

Sponsor Role: lead

Responsible Party

Giuseppe De Bernardo

Head of Department of Woman and Child

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Giuseppe De Bernardo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Buon Consiglio Fatebenefratelli

Locations

Vittore Buzzi Children's Hospital, ASST-FBF-Sacco

Milan, Milan, Italy

Ospedale Buon Consiglio Fatebenefratelli

Naples, Naples, Italy

Countries

Italy

Other Identifiers

496/CE Lazio 1

Identifier Type: -

Identifier Source: org_study_id