Impact of COVID-19 Pandemic on Breastfeeding by Family Vulnerability: An Observational Study Based on Record Linkage.

Objective: The aim of this study was to assess the impact of the coronavirus disease 2019 (COVID-19) pandemic on breastfeeding, overall and across degrees of family vulnerability. Study Design: A repeated cross-sectional study was conducted based on record linkage analysis of regional administrative databases providing data on breastfeeding prevalence in children, collected at the time of months of age. Breastfeeding data were linked to maternal characteristics to calculate a breastfeeding vulnerability score. Data over a 3-year period were considered as follows: 2019 (prepandemic), 2020 (lockdown and strict COVID-19 control measures), and 2021 (milder COVID-19 control measures). Results: During the study period, 110,925 immunization records were registered; data on breastfeeding were available for 107,138 records. The prevalence of full breastfeeding at 3 months of age decreased from 57.1% in 2019 to 56.1% in 2021 (p-value = 0.003), whereas prevalence of full breastfeeding at 5 months of age increased (from 44.1% in 2019 to 47.6% in 2021; p-value <0.001). The vulnerability score was calculated for the 70,253 records (63.3% of the initial sample) for which data were accessible: 5% of the sample was in the lowest vulnerability class and 15% in the highest one. As the vulnerability score increased, the prevalence of full breastfeeding at 3 and 5 months of age decreased in each of the three study years. Breastfeeding prevalence within each vulnerability class was not affected by the pandemic. On the other hand, the percentage of children in the high vulnerability class (score ≥3) increased by 3.6% in 2021 compared with 2019. Conclusions: The pandemic has not significantly impacted the prevalence of breastfeeding (-1% at 3 months and +3.5% at 5 months), but the proportion of children in the most vulnerable class increased significantly: action should be taken to ensure that during crises or emergencies the most vulnerable groups receive increased breastfeeding protection, promotion, and support.

A prospective cohort study evaluating exclusive breastfeeding in late preterm infants.

BACKGROUND: Breastfeeding can be challenging in neonates born between 34 0/7 and 36 6/7 weeks gestation (late preterm). METHODS: This prospective cohort study aims to evaluate exclusive breastfeeding at discharge, at three and six months of life in late preterm infants, and to identify facilitators and challenges to it. We included late preterm neonates eligible for the rooming-in. Data about breastfeeding at discharge, at three and six months of life were collected. RESULTS: Two hundred and fourteen late preterm infants were included in the study. At discharge 70 infants (32.7%) were fed with human milk and 144 (67.2%) were not. Non-exclusive breastfeeding was more common in women who were primiparous, had hypertension, and who underwent cesarean sections. Non-exclusive breastfeeding was associated with a low birthweight (<2500 g), ≥2 blood glucose controls, weight loss >10%, and longer hospital stay. Early first latch-on and skin-to-skin contact were more frequently associated with exclusive human milk feeding (P<0.001). Late preterm neonates born at 35 weeks showed a significant increase in exclusive human milk feeding at 3 months compared to the rate at discharge (P=0.004). CONCLUSIONS: In this cohort, early first latch-on and immediate skin-to-skin contact resulted associated with exclusive human milk feeding. Despite formula-fed during hospitalization, infants born at ≥35 weeks gestation who were exclusively breastfed at follow-up increased.

Reducing antibiotic prescriptions in children is not associated with higher rate of complications.

Acute otitis media (AOM) and sore throat are common reasons for antibiotic prescription in children. Starting from 2007, evidence-based guidelines and other multifaceted improvement activities (ProBA project) were implemented in Emilia-Romagna, a northern Italian region. Antibiotic prescription rate in the region decreased with time (37% relative reduction from 2005 to 2019). Within the ProBA project, this retrospective observational study, including all hospitals of the region, aims to assess if lower rate of antibiotic prescription was associated with an increased rate of acute mastoiditis and acute rheumatic fever (ARF). Hospital admission rates for acute mastoiditis and ARF from 2005 to 2019 were calculated using ICD-9 codes. Hospital intervention rates for myringotomy, incision of mastoid, and mastoidectomy were also assessed. A comparison with antibiotic prescription rate in the pediatric population was performed. Data were gathered using administrative databases and trends were calculated using Poisson regression. During the study period, rate of mastoiditis and similar diagnosis declined from 54.1 to 33.6 per 100.000 (ß coefficient = - 0.047, p value < 0.001) and rate of surgical treatment from 134.6 to 89.6 per 100.000 (ß coefficient = - 0.036, p value < 0.001), whereas rate of ARF remained stable at around 4.4-4.8 per 100.000 (ß coefficient = - 0.009, p value = 0.472).Conclusion: ProBA project implementation-recommending 5 days of amoxicillin for AOM when needed and 6 days of amoxicillin when streptococcal pharyngitis is detected-was associated with a reduced antibiotic use without an increase of complications. What is Known: • Acute otitis media (AOM) and streptococcal pharyngitis are common pediatric infections and frequent cause of antibiotics prescription. • Fear of rare complications like mastoiditis and acute rheumatic fever can hinder health professionals' compliance with evidence-based guideline. What is New: • Guidelines recommending a short course of antibiotics for AOM and streptococcal pharyngitis are associated with reduced antibiotic prescriptions and no increase of complications. • Analysis based on administrative databases is useful for monitoring projects and supporting health professionals in complying with guidelines.

Formula feeding increases the risk of antibiotic prescriptions in children up to 2 years: results from a cohort study.

Association between the use of infant formula and risks for infants' health is seldom studied in western countries. We set up a historical cohort based on record linkage analysis, combining the data from administrative databases providing individual data. Infants receiving the second dose of pediatric immunization between 2015 and 2017 were included. The main outcome measure was antibiotic prescriptions from enrolment up to 24 months of age, by infant feeding category at enrolment. The extended Cox regression technique was used to account for recurrent events. The infants' cohort included 40,258 5-month-old infants; during the study period, 60,932 antibiotic prescriptions were filled. Compared with infants fully breastfed, children fed with both maternal milk and formula received 106 more antibiotic prescriptions per 1000 children/year, whereas infants receiving formula only had 138 excess prescriptions per 1000 children/year. The association with infant feeding was statistically significant and remained unchanged after adjustment for common confounders (adjusted hazard ratio, HR, for complementary feeding vs full breastfeeding 1.09; 95%CI 1.05 to 1.12; formula only versus full breastfeeding adj. HR 1.12; 95%CI 1.08 to 1.16).Conclusion: In our cohort, we observed a positive association between infant formula use considered a proxy of infections antibiotic prescription rate, considered a proxy of infections. The association followed a gradient.What is Known:• Formula feeding is associated with increased morbidity and mortality even in western countries, but still, it is common.• Information on formula are seldom unbiased; thus, public perception of risks is distorted.What is New:• In a large Italian cohort of infants, formula feeding at 5 months of age results to be associated with an increased rate of antibiotic prescription (considered to be a proxy of infection) up to 24 months of age: the association follows a dose-response relationship.• Record linkage analysis using administrative databases provides useful information at a limited cost.

Observational pre-post study showed that a quality improvement project reduced paediatric antibiotic prescribing rates in primary care.

AIM: This study assessed the effectiveness of a quality improvement project that aimed to promote more considered antibiotic prescribing in paediatric primary care. METHOD: This was an observational pre-post study that used patient-level prescribing data from the Emilia-Romagna region of Italy to monitor indicators from 2005 to 2016. Multilevel interventions and activities were started in 2007 and these included developing guidelines and updates, disseminating evidence, audits and feedback, public information campaigns, engaging health managers and performance incentives. The primary outcomes were total antibiotic prescription rates for children aged 0-13 years and the rates for specific drugs. RESULTS: The intervention was associated with a significant reduction in the antibiotic prescribing rate, from 1307 per 1000 children in 2005 to 881 prescriptions in 2016 (p for trend <0.001), and a significant increase in the ratio of amoxicillin to amoxicillin-clavulanic acid, from 0.6 to 1.1 (p for trend = 0.001). Prescriptions of other second-choice antibiotics also declined significantly. In contrast, antibiotic prescribing rates remained high in the rest of Italy. CONCLUSION: The intervention was effective in promoting a more considered use of antibiotic in paediatric primary care in an Italian region. Further studies are needed to confirm its effectiveness in other settings.

Corrigendum to "Are the Two Human Papillomavirus Vaccines Really Similar? A Systematic Review of Available Evidence: Efficacy of the Two Vaccines against HPV".

[This corrects the article DOI: 10.1155/2015/435141.].

Regular monitoring of breast-feeding rates: feasible and sustainable. The Emilia-Romagna experience.

OBJECTIVE: An efficient breast-feeding monitoring system should be in place in every country to assist policy makers and health professionals plan activities to reach optimal breast-feeding rates. Design/Setting/Subjects From March to June 2015, breast-feeding rates at 3 and 5 months of age were monitored in Emilia-Romagna, an Italian region, using four questions added to a newly developed paediatric immunization database with single records for each individual. Data were collected at primary-care centres. Breast-feeding definitions and 24 h recall as recommended by the WHO were used. Direct age standardization was applied to breast-feeding rates. Record linkage with the medical birth database was attempted to identify maternal, pregnancy and delivery factors associated with full breast-feeding rates at 3 and 5 months of age. RESULTS: Data on breast-feeding were collected for 14044 infants. The mean regional full breast-feeding rate at 3 months was 52 %; differences between local health authorities ranged from 42 to 62 %. At 5 months of age, the mean regional full breast-feeding rate dropped to 33 % (range between local health authorities: 26 to 46 %). Record linkage with the birth certificate database was successful for 93 % of records. Total observations more than doubled with respect to the previous regional survey. CONCLUSIONS: The new monitoring system implemented in 2015 in Emilia-Romagna region, totally integrated with the immunization database, has proved to be feasible, sustainable and more efficient than the previous one. This system can be a model for other regions and countries where the vast majority of mothers obtain vaccinations from public health facilities and that already have an immunization database in place.

Prenatal education for congenital toxoplasmosis.

BACKGROUND: Congenital toxoplasmosis is considered a rare but potentially severe infection. Prenatal education about congenital toxoplasmosis could be the most efficient and least harmful intervention, yet its effectiveness is uncertain. OBJECTIVES: To assess the effects of prenatal education for preventing congenital toxoplasmosis. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 May 2015), and reference lists of relevant papers, reviews and websites. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials of all types of prenatal education on toxoplasmosis infection during pregnancy. Cluster-randomized trials were eligible for inclusion. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and checked them for accuracy. MAIN RESULTS: Two cluster-randomized controlled trials (RCTs) (involving a total of 5455 women) met the inclusion criteria. The two included trials measured the effectiveness of the intervention in different ways, which meant that meta-analysis of the results was not possible. The overall quality of the two studies, as assessed using the GRADE approach, was low, with high risk of detection and attrition bias in both included trials.One trial (432 women enrolled) conducted in Canada was judged of low methodological quality. This trial did not report on any of the review's pre-specified primary outcomes and the secondary outcomes reported results only as P values. Moreover, losses to follow-up were high (34%, 147 out of 432 women initially enrolled). The authors concluded that prenatal education can effectively change pregnant women's behavior as it increased pet, personal and food hygiene. The second trial conducted in France was also judged of low methodological quality. Losses to follow-up were also high (44.5%, 2233 out of 5023 women initially enrolled) and differential (40% in the intervention group and 52% in the control group). The authors concluded that prenatal education for congenital toxoplasmoses has a significant effect on improving women's knowledge, whereas it has no effect on changing women's behavior. In this trial 17/3949 pregnant women seroconverted for toxoplasmosis: 13/2591 (0.5%) in the intervention group and 4/1358 (0.3%) in the control group. The rate of seroconversion detected during the study did not differ between groups (risk ratio (RR) 1.70, 95% confidence interval (CI) 0.56 to 5.21; participants = 3949; studies = one, low quality evidence). The number of events was too small to reach conclusions about the effect of prenatal education on seroconversion rate during pregnancy.No other randomized trials on the effect of prenatal education on congenital toxoplasmosis rate, or toxoplasmosis seroconversion rate during pregnancy were detected. AUTHORS' CONCLUSIONS: Even though primary prevention of congenital toxoplasmosis is considered a desirable intervention, given the lack of related risks compared to secondary and tertiary prevention, its effectiveness has not been adequately evaluated. There is very little evidence from RCTs that prenatal education is effective in reducing congenital toxoplasmosis even though evidence from observational studies suggests it is. Given the lack of good evidence supporting prenatal education for congenital toxoplasmosis prevention, further RCTs are needed to confirm any potential benefits and to further quantify the impact of different sets of educational intervention.

Are the Two Human Papillomavirus Vaccines Really Similar? A Systematic Review of Available Evidence: Efficacy of the Two Vaccines against HPV.

BACKGROUND: When the bivalent and the quadrivalent HPV vaccines were marketed they were presented as having comparable efficacy against cervical cancer. Differences between the vaccines are HPV types included and formulation of the adjuvant. METHOD: A systematic review was conducted to assess the efficacy of the two vaccines against cervical cancer. Outcomes considered were CIN2+, CIN3+, and AIS. RESULTS: Nine reports (38,419 women) were included. At enrollment mean age of women was 20 years, 90% had negative cytology, and 80% were seronegative and/or DNA negative for HPV 16 or 18 (naïve women). In the TVC-naïve, VE against CIN2+ was 58% (95% CI: 35, 72); heterogeneity was detected, VE being 65% (95% CI: 54, 74) for the bivalent and 43% (95% CI: 23, 57) for the quadrivalent. VE against CIN3+ was 78% (95% CI: <0, 97); heterogeneity was substantial, VE being 93% (95% CI: 77, 98) for the bivalent and 43% (95% CI: 12, 63) for the quadrivalent. VE in the TVC was much lower. No sufficient data were available on AIS. CONCLUSIONS: In naïve girls bivalent vaccine shows higher efficacy, even if the number of events detected is low. In women already infected the benefit of the vaccination seems negligible.

Baby-friendly hospitals and cesarean section rate: a survey of Italian hospitals.

BACKGROUND: The Baby-Friendly Hospital Initiative aims at protecting, promoting, and supporting breastfeeding. Cesarean section is known to represent an obstacle to breastfeeding. In this observational study we compared Baby-Friendly and non-Baby-Friendly hospitals (BFHs and non-BFHs, respectively) in terms of cesarean section rate. MATERIALS AND METHODS: Italian BFHs were compared with non-BFHs located in the same regions. Data used for analysis were type of hospital, annual deliveries, annual cesarean section deliveries, region of location, and BFH status. The primary outcome was a cesarean section rate below a threshold specific for the identified regions; because of skewed distribution, the median rate was chosen. Descriptive and comparative univariate and multivariate analyses were carried out. RESULTS: In 2009, in Italy, there were 20 BFHs located in eight regions. Compared with the 207 non-BFHs with more than 200 annual deliveries located in the same regions, BFHs had a cesarean section rate below the median of the eight regions (30.4%; interquartile range 14.6%), even after adjustment for confounders (adjusted odds ratio, 12.71; 95% confidence interval, 1.84, 87.72). In addition, being a public hospital, performing a higher number of deliveries, and being located in specific regions also predicted a cesarean section rate below the median. Overall, the regions with at least one BFH showed a lower cesarean section rate, compared with regions without BFHs. DISCUSSION: In Italy there are few BFHs, but regions with at least one BFH show a cesarean section rate below the national median. Several factors impact on the cesarean section rate, causing huge variation among regions. Nevertheless, within the same region, BFHs have a lower cesarean section rate compared with non-BFHs.

Prenatal education for congenital toxoplasmosis.

BACKGROUND: Congenital toxoplasmosis is considered a rare but potentially severe infection. Prenatal education about congenital toxoplasmosis could be the most efficient and least harmful intervention, yet its effectiveness is uncertain. OBJECTIVES: To assess the effects of prenatal education for preventing congenital toxoplasmosis. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (15 January 2012), PubMed (1966 to 15 January 2012), EMBASE (1980 to 15 January 2012), CINAHL (1982 to 15 January 2012), LILACS (1982 to 15 January 2012), IMEMR (1984 to 15 January 2012), and reference lists of relevant papers, reviews and websites. SELECTION CRITERIA: Randomized and quasi-randomized controlled trials (RCTs) of all types of prenatal education on toxoplasmosis infection during pregnancy. Cluster-randomized trials were included. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and study quality. Two review authors extracted data. Data were checked for accuracy. MAIN RESULTS: Two cluster-randomized controlled trials (involving a total of 5455 women) met the inclusion criteria. The two included trials measured the effectiveness of the intervention in different ways which meant that meta-analysis of the results was not possible One trial (432 women enrolled) conducted in Canada was judged of low methodological quality. The authors did not report measure of association but only provided P values (P less than 0.05) for all outcomes. Moreover, losses to follow-up were high (34%, 147 out of 432 women initially enrolled). The authors concluded that prenatal education can effectively change pregnant women's behavior as it increased pet, personal and food hygiene. The second trial conducted in France was also judged of low methodological quality. Losses to follow-up were high (44.5%, 2233 out of 5023 women initially enrolled) and differential (40% in the intervention group and 52% in the control group). The authors concluded that prenatal education for congenital toxoplasmoses has a significant effect on improving women's knowledge whereas it has no effect on changing women's behavior. In this trial 17/3949 pregnant women seroconverted for toxoplasmosis: 13/2591 (0.5%) in the intervention group and 4/1358 (0.3%) in the control group. The number of events was too small to reach conclusions about the effect of prenatal education on seroconversion rate during pregnancy.No other randomized trials on the effect of prenatal education on congenital toxoplasmosis rate, or toxoplasmosis seroconversion rate during pregnancy were detected. AUTHORS' CONCLUSIONS: Even though primary prevention of congenital toxoplasmosis is considered a desirable intervention, given the lack of related risks compared to secondary and tertiary prevention, its effectiveness has not been adequately evaluated. There is very little evidence from RCTs that prenatal education is effective in reducing congenital toxoplasmosis even though evidence from observational studies suggests it is. Given the lack of good evidence supporting prenatal education for congenital toxoplasmosis prevention, further RCTs are needed to confirm any potential benefits and to further quantify the impact of different sets of educational intervention.

A population based cohort study to assess the safety of pandemic influenza vaccine Focetria in Emilia-Romagna region, Italy - part two.

INTRODUCTION: A two phases post authorization safety and effectiveness study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria (Novartis Vaccines & Diagnostics, Siena, Italy), was conducted in Emilia-Romagna region, Italy during the 2009 A/H1N1 influenza pandemic. The second phase study aim was to detect short- and long-term adverse events of special interest (AESIs) following vaccination, and to measure vaccine effectiveness in term of hospital admissions. STUDY DESIGN AND METHOD: A population-based cohort study using record linkage of automated healthcare databases is described. Focetria was administered to 127,522 subjects between October 2009 and February 2010. Vaccinated subjects were generally less healthy than unvaccinated ones. Propensity to be vaccinated was calculated for each subject, and vaccinated and unvaccinated subjects were matched accordingly (103,642 subjects in each group). AESIs were validated against clinical records. RESULTS: In the overall (pre-matching) cohort, a total of 504 short-term incident AESIs (28 in 127,522 vaccinated and 476 in 3,967,917 unvaccinated subjects) were registered (unadjusted OR: 1.8; 95% CI: 1.2, 2.7). No fatalities were recorded. In the matched cohort, a total of 26 short-term incident AESIs (11 in the vaccinated and 15 in the unvaccinated group) were registered, with no differences between groups (OR: 0.7; 95% CI: 0.3, 1.6). Most frequent short-term incident AESIs were convulsions (4 out of 11), and demyelinating diseases (3 out of 11). In the long-term a total of 121 incident AESIs (60 in the vaccinated and 61 in the unvaccinated group) were registered, with no differences between groups (OR: 1.0; 95% CI: 0.7, 1.4). Most common long-term incident AESIs were demyelinating diseases (21 out of 60), and vasculitis (13 out of 60). Vaccine effectiveness was not assessed as the majority of subjects were vaccinated at the end of the pandemic peak and few cases (<0.1%) had laboratory confirmation. CONCLUSIONS: This population-based cohort study using automated databases suggests that Focetria is not associated with an increase in AESIs.

An early (3-6 weeks) active surveillance study to assess the safety of pandemic influenza vaccine Focetria in a province of Emilia-Romagna region, Italy - part one.

INTRODUCTION: An observational, non-comparative, prospective, surveillance study of individuals vaccinated with the MF59-adjuvanted A/H1N1 influenza vaccine, Focetria, (Novartis Vaccines & Diagnostics, Siena, Italy), was performed in Italy during the 2009 A/H1N1 influenza pandemic. METHOD: This study assessed the short-term (six-week) safety profile of the investigational vaccine in real time. After vaccination (N=7943), adverse events (AE) were assessed using both active (telephone) and passive (healthcare database) follow-up in enrolled vaccinated subjects, including infants (6-23 months), pregnant women, and the immunosuppressed. The treating physicians of all subjects experiencing AEs post-vaccination were consulted for clinical information on the conditions reported. All AEs were coded according to ICD-10. RESULTS: A total of 1583 AEs occurred during the study, 67 (4.2%) of which were serious adverse events (SAEs). One SAE was considered to be possibly related to vaccination (transitory and ill-defined neurologic disorder experienced by a 16-year-old asthmatic male). Three adverse events of special interest (AESI) were identified (convulsions experienced by two epileptic subjects), none of which were considered to be vaccine-related. Six individuals died during the study period, in each case the cause of death was not related to vaccination (four cases of severe underlying co-morbidity, one case of psychoactive drug misuse, and one case of acute myocardial infarction). CONCLUSIONS: No cases of clinically relevant AEs, SAEs, or AESI were observed within a six-week period of vaccine administration. In accordance with existing clinical and post-marketing safety data, the results of this active surveillance study demonstrate a good safety profile for the MF59-adjuvanted A/H1N1 vaccine, Focetria, within the general population.