Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05958251 |
| Other study ID # |
496 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 30, 2022 |
| Est. completion date |
November 2, 2022 |
Study information
| Verified date |
July 2023 |
| Source |
Ospedale Buon Consiglio Fatebenefratelli |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical 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. 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.
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.
