Clinical trial NCT05958251: The Use of Arnica Montana in the Cicatrization of the Umbilical Cord
Official title: Umbilical Cord Stump Medication with a Topical Dermo Protective Powder Compared to Dry Care in Healthy Full-term and Near-term Newborns: a Two Centres Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Umbilical Cord Issue
Keywords: newborn
umbilical cord care
arnica
complications
infections
Lead sponsor: Ospedale Buon Consiglio Fatebenefratelli
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 326
Sex: ALL
Minimum age (years): 35
Maximum age (years): 42
Standard ages: CHILD
Accepts healthy volunteers: no
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.

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.

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.

Primary outcomes:
measure: Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump
timeFrame: 48 hours after discharge
measure: Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump
timeFrame: 48 hours after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
timeFrame: 48 hours after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
timeFrame: 48 hours after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
timeFrame: 48 hours after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
timeFrame: 48 hours after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on the use of H2O2 and topical treatment with silver nitrate
timeFrame: 48 hours after discharge
Secondary outcomes:
measure: Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump
timeFrame: 1 week after discharge
measure: Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump
timeFrame: 1 week after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
timeFrame: 1 week after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
timeFrame: 1 week after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
timeFrame: 1 week after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
timeFrame: 1 week after discharge
measure: Evaluation of umbilical cord stump medication with Cicaben ® on the use of H2O2 and topical treatment with silver nitrate
timeFrame: 1 week after discharge
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Vittore Buzzi Children's Hospital, ASST-FBF-Sacco
city: Naples
country: Italy
facility: Ospedale Buon Consiglio Fatebenefratelli
Study officials:
affiliation: Ospedale Buon Consiglio Fatebenefratelli
name: Giuseppe De Bernardo, MD
role: PRINCIPAL_INVESTIGATOR
References: