In Italy, 100% of newborns receive ocular antibiotics, even though chlamydia and Neisseria infections occur in less than 0.001% of cases.
The European survey aimed at establishing clear and standardised guidelines in EU countries on newborn eye health starts today. The survey, designed and led by Cinzia Auriti, neonatologist and lecturer at UniCamillus University, will be conducted over two days to collect data on current practices for the prophylaxis of ophthalmia neonatorum.
The project aims to involve maternity centres across Europe. In addition to UniCamillus University, other participants include the European Society for Paediatric Research, the Italian Society of Neonatology (SIN) and the Cliniques universitaires Saint-Luc in Brussels.
Unclear European guidelines
Neonatal conjunctivitis, also known as ophthalmia neonatorum (ON) is an eye infection that occurs in the first 28 days of life, often caused by bacteria such as Chlamydia trachomatis and Neisseria gonorrhoeae. Currently, the WHO recommends eye prophylaxis to prevent these infections in all newborns, but practices vary widely between countries as the prevalence of conjunctivitis caused by these germs varies. In Europe, there are countries where no prophylaxis is given and others where the WHO recommendations are followed.
Today, we need to reduce the inappropriate use of antibiotics. The aim of this European survey is to collect data on the number of neonatal conjunctivitis cases due to Chlamydia trachomatis and Neisseria gonorrhoeae, the use of conjunctival antibiotics in the newborn at birth and the criteria for their administration, and to produce standardised recommendations that will help to reduce inappropriate use of antibiotics.
In Italy, the law on neonatal antibiotic prophylaxis dates back to 1940, when it was established that all newborns should receive a conjunctival instillation of 1% silver nitrate: the aim was to prevent neonatal blindness. However, a law reform in 1975 removed the requirement for universal prophylaxis, and there has been no legislation on the subject since. In 2011, the Ministry of Health issued guidelines on physiological pregnancy. They mention the usefulness of ophthalmia neonatorum prophylaxis at birth, but do not specify how, when and by whom antibiotic treatment should be administered. However, there are cases where prophylaxis is strongly recommended: babies born to mothers with sexually transmitted infections (STIs), babies born to women with unknown obstetric history, babies born to women with risky social behaviour.
We are currently facing two fundamental challenges: the increase in antimicrobial resistance, which leads to the avoidance of the use of antibiotics without any specific indication, and the different practices in European countries due to the lack of common guidelines.
Current situation in Italy
A national survey was conducted in 2022, led by Cinzia Auriti of UniCamillus University and sponsored by the Neonatal Infectiology Study Group of the Italian Society of Neonatology. 302 birth centres in Italy participated in the survey, representing 72.9% of all birth centres. The data covered the two-year period from 2018 to 2020, and included 82.3% of births in that period.
The results showed a strong lack of uniformity in the approach to the problem: only 0.4% of newborns were treated according to WHO guidelines in terms of molecules to be used, modalities and packaging, while 99.6% of newborns were treated with prophylaxis that was different from current recommendations. During the same period, only 12 cases of neonatal conjunctivitis due to Chlamydia trachomatis were observed, i.e. 0.001% of births, and no cases of conjunctivitis due to Neisseria gonorrhoeae.
Despite these data of low or non-existent prevalence of infection, during the two-year period considered, 100% of newborn babies in Italy received ocular antibiotics at birth, other than those recommended and effective against the germs in question, under a law that has long since been repealed.
Current situation in Europe
In Europe, the approach to neonatal ocular prophylaxis varies widely: countries such as Denmark, Sweden, Belgium and the United Kingdom have abandoned universal prophylaxis in favour of prenatal screening and treatment of mothers at risk of STIs; other countries, such as Italy, maintained universal prophylaxis until 2023, but with medicines other than those recommended by the WHO. The medicines used vary: tetracycline, erythromycin and povidone iodine, with differences in formulations, packaging (single dose or not) and choice, often based on cost.
There is a need for a common European protocol to ensure a standardised, evidence-based approach.
Objectives of the survey
The new survey, led by UniCamillus University, aims to collect epidemiological data on ophthalmia neonatorum in order to develop common recommendations on the use of antibiotics in newborns at birth: the results will be crucial in tackling the growing problem of bacterial resistance and ensuring a more rational approach to prophylaxis.
Auriti emphasises the importance of the project: “Our mission is to ensure that every newborn receives the best possible care while minimising the risk of eye infections. Through this survey, we hope to reserve ocular antibiotic prophylaxis for those who really need it based on defined risk factors, avoid inappropriate use of antibiotics, and arrive at common indications that will make it possible to overcome differences in care between countries and regions”.