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

NCT05958251 | Completed

• 1 other identifier: 496/CE Lazio 1
• Study Type: observational
• Target: 326
• Locations: 1 country
• Sites: 2

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.

Conditions

Umbilical Cord Issue

Keywords

newborn; umbilical cord care; arnica; complications; infections

Outcome Measures

Primary Outcomes (7)

• Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump

  Umbilical cord stump detachment will be evaluated by medical examination

  48 hours after discharge

• Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump

  The presence of dry or wet umbilical cord stump will be evaluated by medical examination

  48 hours after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on mild complications

  Mild complications will be evaluated by medical examination

  48 hours after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema

  Periumbilical erythema will be evaluated by medical examination

  48 hours after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions

  Purulent secretions will be evaluated by medical examination

  48 hours after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on granuloma

  Granuloma will be evaluated by medical examination

  48 hours after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on the use of H2O2 and topical treatment with silver nitrate

  The use of H2O2 and topical treatment with silver nitrate will be evaluated by medical examination

  48 hours after discharge

Secondary Outcomes (7)

• Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump

  1 week after discharge

• Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump

  1 week after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on mild complications

  1 week after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema

  1 week after discharge

• Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions

  1 week after discharge

Study Arms (2)

Cicaben

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

Other: Cicaben

Standard dry care

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

Other: Standard Care (in control arm)

Interventions

Cicaben 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).

Cicaben

Standard Care (in control arm) OTHER

Standard care

Standard dry care

Eligibility Criteria

• Age: 35 Weeks - 42 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Ospedale Buon Consiglio Fatebenefratelli: lead

Study Sites (2)

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

Milan, Milan, 20157, Italy

Location

Ospedale Buon Consiglio Fatebenefratelli

Naples, Naples, 80123, Italy

Location

MeSH Terms

Conditions

Infections

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Giuseppe De Bernardo, MD

  Ospedale Buon Consiglio Fatebenefratelli

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Department of Woman and Child

Study Record Dates

• First Submitted: July 4, 2023
• First Posted: July 24, 2023
• Study Start: May 30, 2022
• Primary Completion: November 2, 2022
• Study Completion: November 2, 2022
• Last Updated: September 19, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (2)