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Umbilical Cord IssueNCT05958251

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

An observational study of Umbilical Cord Issue, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 35 to 42 weeks
Conditions the study is for
Umbilical Cord Issue
What is being tested?
Cicaben
How many people
326 participants
Where
2 sitesItaly
Study dates
30 May 2022to 2 Nov 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 42 weeks
  • All sexes
  • No healthy volunteers
  • Child

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.

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

Italy2 sites
  • Vittore Buzzi Children's Hospital, ASST-FBF-Sacco

    Milan, Milan, 20157

  • Ospedale Buon Consiglio Fatebenefratelli

    Naples, Naples, 80123

Other trials in Italy

About this study

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

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.

Read the 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.

Being tested
Cicaben, Standard Care (in control arm)
Keywords
newborn, umbilical cord care, arnica, complications, infections
Medical subject headings
Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CicabenOther

    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 Care (in control arm)Other

    Standard care

Study groups in NCT05958251
Study groupRoleWhat they receive
CicabenUmbilical cord stump of the newborns was medicated by Cicaben ® (Orsana S.r.l.), a natural topical dermo-protective powder
Receives: Other: Cicaben
Standard dry careUmbilical cord stump of the newborns was medicated by standard dry care
Receives: Other: Standard Care (in control arm)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump

    Umbilical cord stump detachment will be evaluated by medical examination

    Measured: 48 hours after discharge

  2. 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

    Measured: 48 hours after discharge

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

    Mild complications will be evaluated by medical examination

    Measured: 48 hours after discharge

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

    Periumbilical erythema will be evaluated by medical examination

    Measured: 48 hours after discharge

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

    Purulent secretions will be evaluated by medical examination

    Measured: 48 hours after discharge

  6. Evaluation of umbilical cord stump medication with Cicaben ® on granuloma

    Granuloma will be evaluated by medical examination

    Measured: 48 hours after discharge

  7. 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

    Measured: 48 hours after discharge

Secondary outcomes (7)
  1. Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump

    Umbilical cord stump detachment will be evaluated by medical examination

    Measured: 1 week after discharge

  2. 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

    Measured: 1 week after discharge

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

    Mild complications will be evaluated by medical examination

    Measured: 1 week after discharge

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

    Periumbilical erythema will be evaluated by medical examination

    Measured: 1 week after discharge

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

    Purulent secretions will be evaluated by medical examination

    Measured: 1 week after discharge

  6. Evaluation of umbilical cord stump medication with Cicaben ® on granuloma

    Granuloma will be evaluated by medical examination

    Measured: 1 week after discharge

  7. 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

    Measured: 1 week after discharge

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jul 2023
  2. Study start30 May 2022
  3. Primary completion2 Nov 2022
  4. Study completion2 Nov 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
326 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05958251
Sponsor's protocol ID
496/CE Lazio 1
Status last verified
Jul 2023
First submitted
4 Jul 2023
Last updated
19 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Umbilical Cord Issue, run by Ospedale Buon Consiglio Fatebenefratelli at 2 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump (time frame: 48 hours after discharge). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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