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.
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
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.
- Conditions
- Umbilical Cord Issue
- 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 group | Role | What they receive |
|---|---|---|
| Cicaben | Umbilical cord stump of the newborns was medicated by Cicaben ® (Orsana S.r.l.), a natural topical dermo-protective powder Receives: Other: Cicaben | |
| Standard dry care | Umbilical 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.
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
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
Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
Mild complications will be evaluated by medical examination
Measured: 48 hours after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
Periumbilical erythema will be evaluated by medical examination
Measured: 48 hours after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
Purulent secretions will be evaluated by medical examination
Measured: 48 hours after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
Granuloma will be evaluated by medical examination
Measured: 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
Measured: 48 hours after discharge
Secondary 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
Measured: 1 week 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
Measured: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
Mild complications will be evaluated by medical examination
Measured: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
Periumbilical erythema will be evaluated by medical examination
Measured: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
Purulent secretions will be evaluated by medical examination
Measured: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
Granuloma will be evaluated by medical examination
Measured: 1 week 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
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.
- First posted24 Jul 2023
- Study start30 May 2022
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Umbilical Cord IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Ospedale Buon Consiglio Fatebenefratelli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe De Bernardo, Ospedale Buon Consiglio Fatebenefratelli
- Investigators
- Giuseppe De Bernardo, MD, Principal investigator, Ospedale Buon Consiglio Fatebenefratelli
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
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05958251
- Acronym / sponsor ID
- 496/CE Lazio 1
- Conditions
- Umbilical Cord Issue
- Keywords
- newborn, umbilical cord care, arnica, complications, infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 326 participants (actual)
- Lead sponsor
- Ospedale Buon Consiglio FatebenefratelliUniversity, hospital or other
- Study start
- 30 May 2022 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 24 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cicaben | – | Other: CicabenUmbilical cord stump of the newborns was medicated by Cicaben ® (Orsana S.r.l.), a natural topical dermo-protective powder |
| Standard dry care | – | Other: Standard Care (in control arm)Umbilical cord stump of the newborns was medicated by standard dry care |
Who may qualify
- Ages
- 35 to 42 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- Gestational age > 35 weeks and hospitalization in Standard Neonatal Care.
Key exclusion criteria (1 listed)
- They were excluded newborns admitted in Neonatal Intensive Care Unit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CicabenCicaben® 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). | Other | Cicaben |
| Standard Care (in control arm)Standard care | Other | Standard dry care |
Primary outcome
Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump
Time frame: 48 hours after discharge
Umbilical cord stump detachment will be evaluated by medical examination
Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump
Time frame: 48 hours after discharge
The presence of dry or wet umbilical cord stump will be evaluated by medical examination
Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
Time frame: 48 hours after discharge
Mild complications will be evaluated by medical examination
Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
Time frame: 48 hours after discharge
Periumbilical erythema will be evaluated by medical examination
Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
Time frame: 48 hours after discharge
Purulent secretions will be evaluated by medical examination
Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
Time frame: 48 hours after discharge
Granuloma will be evaluated by medical examination
Evaluation of umbilical cord stump medication with Cicaben ® on the use of H2O2 and topical treatment with silver nitrate
Time frame: 48 hours after discharge
The use of H2O2 and topical treatment with silver nitrate will be evaluated by medical examination
7 secondary outcomes
Evaluation of the Cicaben ® medication on the detachment of the umbilical cord stump
Time frame: 1 week after discharge
Evaluation of the Cicaben ® medication on the presence of dry or wet umbilical cord stump
Time frame: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on mild complications
Time frame: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on periumbilical erythema
Time frame: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on purulent secretions
Time frame: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on granuloma
Time frame: 1 week after discharge
Evaluation of umbilical cord stump medication with Cicaben ® on the use of H2O2 and topical treatment with silver nitrate
Time frame: 1 week after discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giuseppe De Bernardo, MD principal investigator
Ospedale Buon Consiglio Fatebenefratelli
2 sites in 1 country: see every site and its status.
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.