Refractive outcome in preterm newborns with ROP after propranolol treatment. A retrospective observational cohort study

Background: Recent explorative studies suggest that propranolol reduces retinopathy of prematurity (ROP) progression, but the short-term effects of propranolol treatment at 1 year of corrected age have not been extensively evaluated. Methods: A multi-center retrospective observational cohort study was conducted to assess the physical development and the refractive outcome of infants with prior ROP treated with propranolol. Forty-nine infants treated with propranolol were compared with an equal number of patients who did not receive any propranolol therapy and represent the control group, with comparable anthropometrical characteristics and stages of ROP. Results: The weight, length, and head circumference at 1 year of corrected age were similar between infants who had been treated, or not, with propranolol, without any statistically significant differences. Refractive evaluation at 1 year showed spherical equivalent values decreasing with the progression of ROP toward more severe stages of the disease, together with an increasing number of infants with severe myopia. On the contrary, no differences were observed between infants who had been treated with propranolol and those who had not. Conclusion: This study confirms that the progression of ROP induces an increase of refractive errors and suggests that propranolol itself does not affect the refractive outcome. Therefore, if the efficacy of propranolol in counteracting ROP progression is confirmed by further clinical trials, the conclusion will be that propranolol might indirectly improve the visual outcome, reducing the progression of ROP

Ozone as adjuvant support in the treatment of covid-19: a preliminary report of probiozovid trial

This article has been accepted for publication and undergone full peer review but has not been through the copyediting, typesetting, pagination and proofreading process, which may lead to differences between this version and the Version of Record. Please cite this article as doi: 10.1002/jmv.26636.Rationale: The evaluation of new therapeutic resources against COVID-19 represents a priority in clinical research considering the minimal options currently available. Objectives: To evaluate the adjuvant use of systemic oxygen-ozone administration in the early control of disease progression in patients with COVID-19 pneumonia. Methods: PROBIOZOVID is an ongoing, interventional, randomized, prospective, double-arm trial enrolling patient with COVID-19 pneumonia. From a total of 85 patients screened, 28 were recruited. Patients were randomly divided into ozone- autohemotherapy group (14) and control group (14). The procedure consisted in a daily double-treatment with systemic Oxygen-Ozone administration for 7 days. All patients were treated with ad interim best available therapy. Measurements and Main Results: The primary outcome was delta in the number of patients requiring orotracheal-intubation despite treatment. Secondary outcome was the difference of mortality between the two groups. Moreover, haematological parameters were compared before and after treatment. No differences in the characteristics between groups were observed at baseline. As a preliminary report we have observed that one patient for each group needed intubation and was transferred to ITU. No deaths were observed at 7-14 days of follow up. Thirty-day mortality was 8,3% for ozone group and 10% for controls. Ozone therapy didn’t significantly influence inflammation markers, haematology profile and lymphocyte subpopulations of patients treated. Ozone therapy had an impact on the need for the ventilatory support, although didn’t reach statistical significance. Finally, no adverse events related to the use of ozone-autohemotherapy were reported. Conclusions: Preliminary results, although not showing statistically significant benefits of ozone on COVID-19, did not report any toxicity

Antibiotic prophylaxis for ophthalmia neonatorum in Italy: results from a national survey and the Italian intersociety new position statements

Background: Ophthalmia neonatorum is an acute conjunctivitis that occurs in newborns within the first month of life. The most serious infections are due to Chlamydia trachomatis and Neisseria gonorrhoeae, that may cause permanent damages. The use of ophthalmic prophylaxis varies widely around the world, according to the different health and socio-economic contexts. To date in Italy there is no a clear legislation regarding ophthalmia neonatorum prophylaxis at birth. Methods: We invited all birth centers in Italy to carry out a retrospective survey relating the last three years. We collected data regarding demographics of neonates, drugs used for ophthalmic prophylaxis and results of the screening of pregnant women for Chlamydia trachomatis and Neisseria gonorrhoeae vaginal infections. Results: Among 419 birth centers, 302 (72,1%) responded to the survey. Overall 1041384 neonates, 82,3% of those born in the three years considered, received ophthalmic prophylaxis. Only 4,585 (0,4%) of them received one of the drugs recommended by the WHO. The Centers that participated to the survey reported 12 episodes of Chlamydial conjunctivitis and no Gonococcal infection in the three years. Only 38% of the Centers performed vaginal swabs to pregnant women: 2,6% screened only for Neisseria, 9,6% only for Chlamydia and 25,8% for both germs. Conclusions: The data obtained from the survey showed a low incidence of neonatal conjunctivitis due to either Neisseria gonorrhoeae or Chlamydia trachomatis in Italy. Due to the lack of legislation regulating the prophylaxis of ophthalmia neonatorum in newborns, the Italian Society of Neonatology, the Italian Society of Obstetrics and Gynecology and the Italian Society of Perinatal Medicine have recently issued new recommendations on this topic

Propranolol 0.2% eye micro-drops for retinopathy of prematurity : a prospective phase IIb study

Background: Oral propranolol reduces retinopathy of prematurity (ROP) progression, although not safely. Propranolol 0.1% eye micro-drops administered to newborns with stage 2 ROP are well-tolerated, but not sufficiently effective. Methods: A multi-center open-label trial was conducted to assess the safety and efficacy of propranolol 0.2% eye micro-drops in newborns with stage 1 ROP. The progression of the disease was evaluated with serial ophthalmologic examinations. Hemodynamic, respiratory, biochemical parameters, and propranolol plasma levels were monitored. Demographic and perinatal characteristics, co-morbidities and co-intervention incidences, together with ROP progression, were compared with a historical control group in the same centers participating in the trial. Results: Ninety-eight newborns were enrolled and compared with the historical control group. Populations were not perfectly homogeneous (as demonstrated by the differences in the Apgar score and the different incidence rate in surfactant administration and oxygen exposure). The progression to ROP stage 2 or 3 plus was significantly lower than the incidence expected on the basis of historical data (Risk Ratio 0.521, 95% CI 0.297- 0.916). No adverse effects related to propranolol were observed and the mean propranolol plasma level was significantly lower than the safety cutoff of 20 ng/mL. Unexpectedly, three newborns treated with oral propranolol before the appearance of ROP, showed a ROP that was unresponsive to propranolol eye micro-drops and required laser photocoagulation treatment. Conclusion: Propranolol 0.2% eye micro-drops were well-tolerated and appeared to reduce the ROP progression expected on the basis of a comparison with a historical control group. Propranolol administered too early appears to favor a more aggressive ROP, suggesting that a \u3b2-adrenoreceptor blockade is only useful during the proliferative phase. Further randomized placebo-controlled trials are required to confirm the current results

Minimally invasive pilonidal sinus treatment: A narrative review

The management of chronic pilonidal disease remains controversial, but recently, new minimal invasive approaches have been proposed. Whereas in the conventional surgical treatment an elliptical wedge of skin and subcutaneous tissue is created to remove the sinus and its lateral tracks, the basis for our new treatment is to create a minimal elliptical wedge of the subcutaneous tissue, including all the inflamed tissue and debris while leaving the overlying skin intact. The mechanism of an endoscopic approach relies on use of the endoscope without cutaneous tissue damage. Advantages include shorter operative time and time to discharge, which impact resource management in both primary and secondary care: patients undergoing endoscopic technique have a high satisfaction rate, probably due to the low level of postoperative pain and early return to work and daily activities. However, it is mandatory that further studies would analyze surgical approaches to pilonidal sinus disease (PSD) with a consistent and adequate follow-up of at least 5 years. Both sinusectomy and endoscopic approach to PSD were found to be safe and effective compared with conventional techniques. Publishedresults of studies of newer approaches have demonstrated a low short-term complication rate, comparable to conventional surgery results

Survey on retinopathy of prematurity (ROP) in Italy

This study aims to investigate the incidence and the relative risk factors of retinopathy of prematurity (ROP) and posterior-ROP (P-ROP): ROP in Zone I and posterior Zone II, as well as to analyze the occurrence of surgical treatment of ROP and to evaluate the short term outcome of the disease in Italy

La gestione neonatologica dell'infezione congenita da citomegalovirus

Il citomegalovirus (CMV) \ue8 la causa pi\uf9 frequente di infezione virale congenita, interessando lo 0,2-2% dei nati vivi, e pertanto rappresenta un problema rilevante di salute pubblica. I neonati con infezione congenita, sia sintomatici sia asintomatici alla nascita, possono presentare sequele, in particolare ipoacusia neurosensoriale e danno neurologico. Il virus pu\uf2 essere trasmesso al feto sia in seguito ad una infezione materna primaria sia in seguito ad una infezione ricorrente. Nonostante il rischio di trasmissione sia significativamente pi\uf9 elevato in caso di infezione materna primaria che non in caso di infezione ricorrente, non \ue8 ad oggi raccomandato lo screening per CMV in gravidanza in quanto non c\u2019\ue8 sufficiente evidenza in favore di terapie prenatali. Quando l\u2019infezione congenita viene diagnosticata alla nascita, il ganciclovir per via endovenosa o il valganciclovir per os rappresentano i farmaci di scelta per il trattamento dei neonati sintomatici. In base alle evidenze scientifiche attuali, la terapia antivirale dovrebbe essere proseguita per sei mesi nei neonati con infezione di entit\ue0 media/grave. In ogni caso, tutti i neonati con infezione congenita, sia sintomatici sia asintomatici alla nascita, dovrebbero essere seguiti con un programma di follow-up mirato fino all\u2019et\ue0 di sei anni al fine di diagnosticare tempestivamente le sequele tardive e mettere in atto gli interventi riabilitativi necessari. L\u2019esecuzione di uno screening universale alla nascita per l\u2019infezione congenita da CMV sarebbe auspicabile in quanto consentirebbe di identificare anche i neonati con infezione congenita asintomatica alla nascita nati da donne con infezione non primaria in gravidanza. La ricerca del DNA di CMV tramite PCR nella saliva sembra essere il test che presenta le migliori caratteristiche per uno screening. Sicuramente sono necessari studi su larga scala per valutare il rapporto rischio/beneficio di uno screening universale che potrebbe essere determinante nel ridurre il \u201ccarico\u201d derivante dall\u2019infezione congenita da CMV.Cytomegalovirus (CMV) is the leading cause of congenital infection in humans, affecting 0.2-2% of all live births, and thus constitutes a major public health problem. Congenitally infected infants, both symptomatic and asymptomatic at birth, may develop sequelae, especially sensorineural hearing loss and brain damage. The virus can be transmitted to the fetus following either a primary or a non-primary maternal infection during pregnancy. Even though the transmission rate is much higher in primary infected mothers than in mothers with preconceptional immunity, routine CMV screening of pregnant women is not recommended today because no consensus exists on prenatal treatment options. Intravenous ganciclovir or oral valganciclovir are used to treat neonates with symptoms at birth. Valganciclovir treatment for six months is recommended for congenitally infected neonates with moderately to severely symptomatic disease. All infants with congenital CMV infection, both symptomatic and asymptomatic at birth, need a followup evaluation to detect sequelae as early as possible, so that infants can receive intervention promptly. For several years, a universal newborn screening for congenital CMV infection has been suggested by many Authors, inasmuch it would allow us to detect sequelae promptly even in neonates asymptomatic at birth born to women with non-primary infection in pregnancy. A real-time PCR assay of saliva specimens seems to offer the best characteristics for use in screening. Large-scale studies to evaluate the cost/benefit ratio of a universal newborn screening for congenital CMV infection are needed to further reduce the burden of congenital CMV infection