Exhaled Volatile Organic Compounds for Asthma Control Classification in Children with Moderate to Severe Asthma: Results from the SysPharmPediA Study.

RATIONALE: Early identification of children with poorly controlled asthma is imperative for optimizing treatment strategies. The analysis of exhaled volatile organic compounds (VOCs) is an emerging approach to identify prognostic and diagnostic biomarkers in pediatric asthma. OBJECTIVES: To assess the accuracy of gas chromatography-mass spectrometry based exhaled metabolite analysis to differentiate between controlled and uncontrolled pediatric asthma. METHODS: This study encompassed a discovery (SysPharmPediA) and validation phase (U-BIOPRED, PANDA). Firstly, exhaled VOCs that discriminated asthma control levels were identified. Subsequently, outcomes were validated in two independent cohorts. Patients were classified as controlled or uncontrolled, based on asthma control test scores and number of severe attacks in the past year. Additionally, potential of VOCs in predicting two or more future severe asthma attacks in SysPharmPediA was evaluated. MEASUREMENTS AND MAIN RESULTS: Complete data were available for 196 children (SysPharmPediA=100, U-BIOPRED=49, PANDA=47). In SysPharmPediA, after randomly splitting the population into training (n=51) and test sets (n=49), three compounds (acetophenone, ethylbenzene, and styrene) distinguished between uncontrolled and controlled asthmatics. The area under the receiver operating characteristic curve (AUROCC) for training and test sets were respectively: 0.83 (95% CI: 0.65-1.00) and 0.77 (95% CI: 0.58-0.96). Combinations of these VOCs resulted in AUROCCs of 0.74 ±0.06 (UBIOPRED) and 0.68 ±0.05 (PANDA). Attacks prediction tests, resulted in AUROCCs of 0.71 (95% CI 0.51-0.91) and 0.71 (95% CI 0.52-0.90) for training and test sets. CONCLUSIONS: Exhaled metabolites analysis might enable asthma control classification in children. This should stimulate further development of exhaled metabolites-based point-of-care tests in asthma.

Directed acyclic graph for epidemiological studies in childhood food allergy: Construction, user's guide, and application.

Understanding modifiable prenatal and early life causal determinants of food allergy is important for the prevention of the disease. Randomized clinical trials studying environmental and dietary determinants of food allergy may not always be feasible. Identifying risk/protective factors for early-life food allergy often relies on observational studies, which may be affected by confounding bias. The directed acyclic graph (DAG) is a causal diagram useful to guide causal inference from observational epidemiological research. To date, research on food allergy has made little use of this promising method. We performed a literature review of existing evidence with a systematic search, synthesized 32 known risk/protective factors, and constructed a comprehensive DAG for early-life food allergy development. We present an easy-to-use online tool for researchers to re-construct, amend, and modify the DAG along with a user's guide to minimize confounding bias. We estimated that adjustment strategies in 57% of previous observational studies on modifiable factors of childhood food allergy could be improved if the researchers determined their adjustment sets by DAG. Future researchers who are interested in the causal inference of food allergy development in early life can apply the DAG to identify covariates that should and should not be controlled in observational studies.

Potential risk factors for reduced quality of life and increased health care utilization in ARDS survivors: results from the multicenter cohort study DACAPO.

AIM: To analyze the association of individual pre-ICU risk factors (obesity, physical and mental comorbidity, smoking status) on the long-term recovery process in survivors of the acute respiratory distress syndrome (ARDS; outcomes: health related quality of life, health care utilization; measured at 12, 24, and 36 months after ICU discharge). FINDINGS: Results show a possible causal link between pre-ICU risk factors and subsequent recovery of survivors of ARDS, especially with regard to mental health related quality of life. PURPOSE: Identifying relevant pre-existing risk factors, such as mental health problems, will enable the identification of at-risk patients, thus aiding in the improvement of long-term healthcare for survivors of critical illness.

Deriving acceptable limits for non-mutagenic impurities in medicinal products - Durational adjustments.

ICH Q3A/B guidelines are not intended for application during the clinical research phase of development and durationally adjusted qualification thresholds are not included. A central tenet of ICH Q3A is that lifetime exposure to 1 mg/day of an unqualified non-mutagenic impurity (NMI) is not a safety concern. An analysis of in vivo toxicology data from 4878 unique chemicals with established NO(A)ELs was conducted to determine whether durationally adjusted qualification limits can be supported. Although not recommended in ICH Q3A/B, a conservative approach was taken by using allometric scaling in the analysis. Following allometric scaling of the 5th percentile of the distribution of NO(A)ELs from available chronic toxicology studies, it was reconfirmed that there is a safety basis for the 1 mg/day qualification threshold in ICH Q3A. Additionally, allometric scaling of the 5th percentile of the distribution of NO(A)ELs from sub-acute and sub-chronic toxicology studies could support acceptable limits of 20 and 5 mg/day for an unqualified NMI for dosing durations of less than or greater than one month, respectively. This analysis supports durationally adjusted NMI qualification thresholds for pharmaceuticals that protect patient safety and contribute to 3Rs efforts for qualifying impurities using new approach methods.

Classifying asthma control using salivary and fecal bacterial microbiome in children with moderate-to-severe asthma.

BACKGROUND: Uncontrolled asthma can lead to severe exacerbations and reduced quality of life. Research has shown that the microbiome may be linked with asthma characteristics; however, its association with asthma control has not been explored. We aimed to investigate whether the gastrointestinal microbiome can be used to discriminate between uncontrolled and controlled asthma in children. METHODS: 143 and 103 feces samples were obtained from 143 children with moderate-to-severe asthma aged 6 to 17 years from the SysPharmPediA study. Patients were classified as controlled or uncontrolled asthmatics, and their microbiome at species level was compared using global (alpha/beta) diversity, conventional differential abundance analysis (DAA, analysis of compositions of microbiomes with bias correction), and machine learning [Recursive Ensemble Feature Selection (REFS)]. RESULTS: Global diversity and DAA did not find significant differences between controlled and uncontrolled pediatric asthmatics. REFS detected a set of taxa, including Haemophilus and Veillonella, differentiating uncontrolled and controlled asthma with an average classification accuracy of 81% (saliva) and 86% (feces). These taxa showed enrichment in taxa previously associated with inflammatory diseases for both sampling compartments, and with COPD for the saliva samples. CONCLUSION: Controlled and uncontrolled children with asthma can be differentiated based on their gastrointestinal microbiome using machine learning, specifically REFS. Our results show an association between asthma control and the gastrointestinal microbiome. This suggests that the gastrointestinal microbiome may be a potential biomarker for treatment responsiveness and thereby help to improve asthma control in children.

Piloting an ICU follow-up clinic to improve health-related quality of life in ICU survivors after a prolonged intensive care stay (PINA): feasibility of a pragmatic randomised controlled trial.

BACKGROUND: ICU survivors often suffer from prolonged physical and mental impairments resulting in the so called "Post-Intensive Care Syndrome" (PICS). The aftercare of former ICU patients affected by PICS in particular has not been addressed sufficiently in Germany so far. The aim of this study was to evaluate the feasibility of a pragmatic randomised trial (RCT) comparing an intensive care unit (ICU) follow-up clinic intervention to usual care. METHODS: This pilot study in a German university hospital evaluated the feasibility of a pragmatic RCT. Patients were assigned in a 1:1 ratio to an ICU follow-up clinic intervention or to usual care. The concept of this follow-up clinic was previously developed in a participatory process with patients, next of kin, health care professionals and researchers. We performed a process evaluation and determined acceptability, fidelity, completeness of measurement instruments and practicality as feasibility outcomes. The RCT's primary outcome (health-related quality of life) was assessed six months after ICU discharge by means of the physical component scale of the Short-Form-12 self-report questionnaire. RESULTS: The pilot study was conducted from June 2020 to May 2021 with 21 and 20 participants in the intervention and control group. Principal findings related to feasibility were 85% consent rate (N = 48), 62% fidelity rate, 34% attrition rate (N = 41) and 77% completeness of outcome measurements. The primary effectiveness outcome (health-related quality of life) could be measured in 93% of participants who completed the study (N = 27). The majority of participants (85%) needed assistance with follow-up questionnaires (practicality). Median length of ICU stay was 13 days and 85% (N = 41) received mechanical ventilation, median Sequential Organ Failure Assessment Score was nine. Six-month follow-up assessment was planned for all study participants and performed for 66% (N = 41) of the participants after 197 days (median). CONCLUSION: The participatory developed intervention of an ICU follow-up clinic and the pragmatic pilot RCT both seem to be feasible. We recommend to start a pragmatic RCT on the effectiveness of the ICU follow-up clinic. TRIAL REGISTRATION: ClinicalTrials.gov US NLM, NCT04186468, Submission: 02/12/2019, Registration: 04/12/2019, https://clinicaltrials.gov/ct2/show/NCT04186468.

[Frequency of Utilization of Medical and Paramedical Care in Infants with Excessive Crying: Cross- Sectional Analysis and Parent Survey]. / Inanspruchnahme medizinischer und paramedizinischer Versorgung bei Säuglingen mit exzessivem Schreien: Querschnittsanalyse und Eltern-Survey.

BACKGROUND: Infants can present in the first year of life with excessive, recurrent crying without an apparent illness or failure to thrive. The excessive crying results in a wide variety of problems for infants, parents and health care service. OBJECTIVES: This study aimed at evaluating how often parents of children with excessive crying seek help in the medical and paramedical health care system and which therapies are prescribed. MATERIALS AND METHODS: This study uses data collected within KUNO Kids health study. Families who participated completed questionnaires 4 weeks after birth and answered questions which screened for excessive crying. Families whose child was screened positive completed an additional questionnaire on symptoms, parental management and health care utilization. Data were analysed using descriptive statistics. RESULTS: We received 238 questionnaires from children with excessive crying, 105 fulfilled the modified Wessel criteria. Of these 37 children (36%) were seen by a pediatrician because of crying. 57 (55%) received medications by the pediatrician. 51 (49%) of the parents specified that they also used paramedical therapies due to crying or whining, most often osteopathy. 45 (43%) adapted their own nutrition or their child's nutrition. CONCLUSIONS: Our study shows that parents experience problems in dealing excessive crying. Frequent consultations with pediatricians or use of paramedical therapies are common, demanding additional resources. The parents received different diagnoses for excessive crying. Available drugs like Simeticon, homeopathy or manual therapy are recommended and applied despite largely missing evidence.

Maternal knowledge of recommendations for safe infant sleep and intentions for implementation - a cross sectional analysis of data from the KUNO-Kids birth cohort study.

OBJECTIVES: Despite major advances in prevention, sudden infant death syndrome (SIDS) remains an important cause of infant mortality. The aim of our study was to determine actual knowledge and intentions to implement SIDS prevention measures among new mothers and to identify potential knowledge gaps for improved postpartum counselling strategies. METHODS: Data was collected in a standardized interview from participants of the KUNO-Kids birth cohort study before discharge from maternity ward. The mothers did not receive any specific teaching prior to the interview. RESULTS: The majority of 2,526 interviewed mothers were able to actively report important recommendations for safe infant sleep, including the exclusive face-up position. However, 154 mothers (9%) intended to position the newborn face-down sometimes or often. The most frequently envisaged sleeping furniture was a bedside sleeper (n=1,144, 47%), but 2.2% of mothers indicated that the intended default sleeping place for the newborn would be the parents' bed (which is discouraged by the recommendations). For 43% of the infants (n=1,079), mothers planned to have loose objects in the bed and 189 mothers (7%) intended to use a loose blanket. 22% of infants (n=554) will live in a household with a smoker. Multivariate regression showed a significant association of "good knowledge" with maternal age and with not being a single parent, whereas the household size was negatively associated. CONCLUSION: Although the majority of mothers in our birth cohort were aware of many recommendations for safe infant sleep, our data also uncovered weaknesses in SIDS prevention knowledge and point to specific areas with potential for improved counselling.

Food allergy in infants assessed in two German birth cohorts 10 years after the EuroPrevall Study.

BACKGROUND: The prevalence of food allergies (FA) in children increased rapidly at the turn of the century. The EuroPrevall study identified Germany as a country with very high prevalence of FA at that time. Using two large German birth cohorts, we provide an update of the status quo 10 years later. METHODS: KUNO Kids and Ulm SPATZ Health studies are two ongoing prospective birth cohorts. Information on FA was obtained by questionnaires at birth and after 6, 12, and 24 months. Univariable and multivariable logistic regression analyses were performed to investigate risk factors during pregnancy, birth, and early childhood. RESULTS: In 1139 and 1006 children from KUNO Kids and SPATZ, the point prevalence of parent-reported FA symptoms at the ages of 1 and 2 years was 13.2% (95% CI: 11.2-15.2) and 13.9% (95% CI: 11.5-17.2) in KUNO Kids. Doctor's diagnosed FA at 1 and 2 years was 2.4% (95% CI: 1.6-3.4) and 2.7% (95% CI: 1.2-4.3) in KUNO Kids and 2.3% (95% CI: 1.3-3.6) and 3% (95% CI: 2.0-4.5) in SPATZ. Cow's milk and citrus fruits were most frequently suspected by parents to cause FA symptoms. Atopy in the child was associated with a higher frequency of FA at any time, whereas atopy in first-degree relatives was only associated with FA at year 1. Smoke exposure during pregnancy was a risk for FA at age 2. CONCLUSION: The prevalence of food allergy seems to have plateaued in the last 10 years in Germany. FA is often suspected by parents but only rarely diagnosed by oral food challenge. Risk factor analysis may help to establish personalized health approaches.

Prevalences of cardiometabolic risk and lifestyle factors in young parents: evidence from a German birth cohort study.

BACKGROUND: Studies show that parents significantly impact their children's health through their cardiometabolic risk profile and health behavior. There is only little information about the prevalence of cardiometabolic risk factors and lifestyle factors among new parents yet. The aims of this study are therefore to evaluate the prevalences of cardiometabolic risk factors in parents of infants in Germany and to examine their lifestyle and health behavior. METHODS: In the KUNO-Kids health study, an ongoing birth cohort, parents (n = 930 mothers and 769 fathers) were asked about cardiometabolic risk factors (obesity/hypertension/type 2 diabetes mellitus) and lifestyle factors (dietary/sports/smoking habits/alcohol consumption) during the first year after the birth of their children via questionnaires. Chi-square as well as fisher exact tests were conducted to analyse associations between lifestyle factors and cardiometabolic risk factors. RESULTS: 34.2% of mothers and 58.5% of fathers were overweight or obese. In 11.8% of the families, at least one parent suffered from hypertension, in 2.4% from type 2 diabetes mellitus. One year after delivery, 8.5% of mothers were smoking, 6.9% showed a risky alcohol consumption (> 10 g/d). 16.0% of fathers were smoking 4 weeks after childbirth, 10.7% showed risky alcohol consumption (> 20 g/d). 21.6% of mothers carried out sports activity for more than 2 h a week then. Parental hypertension was linked to a higher prevalence of risky alcohol consumption, obesity to a lower prevalence of daily fruits consumption. CONCLUSIONS: Cardiometabolic risk factors were widespread among new parents with obesity and overweight having the highest prevalences. A considerable number of parents also practiced an unhealthy lifestyle showing that there is potential for improvement to promote the healthy development of their children.

Utilisation of supplementary prenatal screening and diagnostics in Germany: cross-sectional study using data from the KUNO Kids Health Study.

BACKGROUND: Appropriate health system utilisation during pregnancy is fundamental for maintaining maternal and child's health. To study the use and determinants of supplementary prenatal screening and diagnostics in Germany this study provides comprehensive data. METHODS: We obtained data from a recently established prospective German birth cohort study, the KUNO Kids Health Study. Analyses are based on Andersen's Behavioural Model of health system use, which distinguishes between predisposing (e.g. country of birth), enabling (e.g. health insurance) and need factors (e.g. at-risk pregnancy). We examined bi- and multivariate association with the use of supplementary prenatal screening and diagnostics using logistic regression. RESULTS: The study has a sample size of 1886 participating mothers. One fifth of the mothers investigated did not use any supplementary prenatal screening or diagnostics. Notably, the chance of using supplementary prenatal screening and diagnostics more than doubled if the pregnant woman had a private health insurance (OR 2.336; 95% CI 1.527-3.573). Higher maternal age (OR 1.038; 95% CI 1.006-1.071) and environmental tobacco smoke exposure (OR 1.465 95% CI 1.071-2.004) increased the use of supplementary prenatal screening and diagnostics. However, regarding need factors only having an at-risk-pregnancy (OR 1.688; 95% CI 1.271-2.241) showed an independent association. CONCLUSION: The important role of the type of health insurance and the relatively small influence of need factors was surprising. Especially with respect to equity in accessing health care, this needs further attention.

Pathways linking parental health literacy with health behaviours directed at the child: a scoping review.

Health literacy (HL) is thought to be crucial for the management of the manifold demands relating to child health which parents are faced with. Albeit many studies have investigated parental HL and health behaviours (HBs) directed at the child, knowledge about the pathways which link parental HL with HB is scarce. The aim of this scoping review was to identify and comprehensively describe the variety of pathways linking parental HL with HBs directed at the child which were empirically analysed in previous studies. Following established scoping review methods database searches were conducted in MEDLINE, EMBASE, PsycINFO and WebofScience on 5 March 2020. Eligibility criteria included primary, empirical studies assessing parental HL and HB directed at the child in the general parent population. Titles and abstracts were screened independently by six reviewers for potentially relevant publications and data were extracted using standardized data extraction forms. The search identified 6916 articles for title and abstract screening. After full-text review, 50 studies were included in this review. Most studies (N = 24) assumed a direct association between HL and HBs and only few studies (N = 4) used more complex models investigating different pathways or mediation and/or moderation models. Overall, the evidence on the underlying pathways linking parental HL and HBs directed at the child is mixed and fairly limited. Therefore, hypothesis-driven research and integration of results into theoretical frameworks is needed for advancing both the research on HL and public health practice.

This systematic overview of existing literature aimed at comprehensively describing the association between parental health literacy (HL) and health behaviours (HBs) directed at the child and how this linkage was analysed in previous studies. HL can be defined as the capacity an individual has to access and effectively use health-related information, in order to promote and maintain good health. A particularly relevant group is the parent population as prior to and during parenthood they are confronted with manifold information regarding child health care. Many studies investigated parental HL and HBs directed at the child but knowledge about how they are connected with each other is scarce. The 50 studies included in this review varied widely in how they measured HL and HBs and how data were analysed. Overall, most studies (24 studies) assumed a direct association between HL and HBs and only few studies (4 studies) used more complex models looking at other important variables. More research is needed to understand the underlying relation between HL and HBs and how this can be integrated into theoretical frameworks.

[Parental intention to vaccinate their children against COVID-19]. / COVID-19-Impfintention von Eltern bezogen auf ihre Kinder.

BACKGROUND: With the start of the vaccination campaign, a new phase in the management of the coronavirus pandemic has begun. Approval and recommendation for COVID-19 vaccination of children followed gradually; to date (4 October 2022), vaccination for children under five years of age has not been approved in Germany. AIM OF THE STUDY: The aim was to investigate how parents' intention to vaccinate their children against COVID-19 developed from May 2020 to February 2021 (from the first to the second wave of the COVID-19 pandemic) and to analyse the determinants of the intention to vaccinate. METHODS: In May 2020, 612 families participating with their children aged 1.5-6 years in the KUNO Kids Health Study completed an online survey (participation rate 51%), and 507 completed the second survey in February 2021. Determinants of the intention to vaccinate were analysed for both time points using univariable and multivariable logistic regression models. RESULTS: While 51% of parents reported wanting their children vaccinated against COVID-19 in May 2020, this proportion decreased to 41% by February 2021. At least at one of the two time points, health literacy and perceived competence regarding protective measures against the virus were significantly positively associated with higher vaccination intentions, while belonging to a risk group and the perception that the political measures were exaggerated were associated with lower vaccination intentions. DISCUSSION: Parents' intention to have their children vaccinated against COVID-19 was low and decreased further from the first to the second wave of the coronavirus pandemic. Attitudinal and competence-related determinants were important at both time points and could be targeted in a future vaccination campaign addressing parents of younger children.

Parents' intention to get vaccinated and to have their child vaccinated against COVID-19: cross-sectional analyses using data from the KUNO-Kids health study.

A COVID-19 vaccine can be an important key for mitigating the spread of the pandemic, provided that it is accepted by a sufficient proportion of the population. This study investigated parents' intention to get vaccinated and to have one's child vaccinated against COVID-19. In May 2020, 612 parents participating with their child in the KUNO-Kids health study completed an online survey. Multivariable logistic regression models were calculated to analyze predictors of intention to vaccinate. Fifty-eight percent of parents intended to get vaccinated against COVID-19, and 51% intended to have their child vaccinated. Significant predictors for the intention to get vaccinated and for having the child vaccinated included stronger parental confidence in one's knowledge about prevention measures and lower beliefs that policy measures were exaggerated.Conclusion: COVID-19 vaccination hesitancy was considerable in our sample of parents in Germany. However, our study revealed some potentially modifiable factors which should be addressed by a comprehensive and tailored communication and education strategy. What is Known? • A COVID-19 vaccine can mitigate the spread of the pandemic. • Many parents are skeptical about vaccinations in general. What is New? • COVID-19 vaccination hesitancy was considerable in our sample of parents from Germany, not only for getting vaccinated but also for having the child vaccinated. • Negative parental attitudes regarding policy measures to contain the pandemic were associated with a lower intention to vaccinate.

Prevalence of and factors associated with receipt of provider recommendation for influenza vaccination and uptake of influenza vaccination during pregnancy: cross-sectional study.

BACKGROUND: Seasonal influenza vaccination has been recommended for pregnant women in Germany since 2010. The aim of this study was to examine prevalence and determinants of receipt of provider recommendation for influenza vaccination as well as influenza vaccination uptake during pregnancy. METHODS: We analysed data from the "KUNO Kids Health Study", a prospective birth cohort. During the study period (5th July 2015 to 27th June 2018) data were collected from participating mothers by interview and questionnaire. According to Andersen's behavioural model of health services use potential influencing factors describing the circumstances and characteristics of the mothers and their pregnancies which are potentially affecting whether women receive a recommendation for a vaccination or whether they utilize influenza vaccination were classified into three domains: 'predisposing characteristics', 'enabling resources' and 'need'. Using multivariable logistic regression models odds ratios (OR) and corresponding 95% confidence intervals (95% CI) were calculated. RESULTS: As a combined result across three flu seasons, 368 of 1814 (20.3%) women received an influenza vaccination recommendation during pregnancy. Having had a high-risk pregnancy increased the odds of receiving a vaccination recommendation (OR = 1.3; 95% CI = 1.0-1.6; p = 0.045). In contrast, pregnancy onset in summer (OR = 0.7; 95% CI = 0.5-1.0; p = 0.027), autumn (OR = 0.4; 95% CI = 0.3-0.5; p < =0.001) or winter (OR = 0.5; 95% CI = 0.3-0.6; p < =0.001) (compared to spring) as well as mother's birthplace outside Germany (OR = 0.6; 95% CI = 0.4-0.9; p = 0.023) reduced the chance of getting a vaccination recommendation. Two hundred forty-two of one thousand eight hundred sixty-five (13%) women were vaccinated against influenza during pregnancy. Having received a vaccination recommendation was strongly associated with vaccination uptake (OR = 37.8; 95% CI = 25.5-55.9; p < =0.001). Higher health literacy status was also associated with a higher chance of vaccination uptake (OR = 1.7; 95% CI = 1.2-2.6; p = 0.008), whereas pregnancy onset in autumn (compared to spring) reduced the chance (OR = 0.5; 95% CI = 0.3-0.8; p = 0.008). CONCLUSIONS: At 13% the uptake rate of influenza vaccination is low. Having received a recommendation to vaccinate was strongly associated with uptake but only one fifth of all mothers report such a recommendation. Raising awareness in physicians regarding vaccinating during pregnancy seems to be of essential importance to increase vaccine uptake and to prevent influenza-related complications in pregnant women.

Determinants of maternal health four weeks after delivery: cross-sectional findings from the KUNO-kids health study.

BACKGROUND: The aim of this study was to examine the interaction of a multitude of socio-economic, lifestyle, environmental, psychosocial and birth related determinants and their effect on maternal health four weeks after delivery. METHODS: We used data from a German birth cohort study, the KUNO-Kids health study. Social determinants, as well as the self-rated maternal health and the physical and mental health status of mothers (indicated by means of the SF-12-questionnaire) were assessed through standardized questionnaires and personal interviews right after delivery and four weeks later. Linear regression models were calculated to determine the relationship between influencing factors and health outcomes. RESULTS: 1428 women were included in the analysis. Maternal self-rated health showed significant positive associations with breastfeeding (B (regression coefficient) 2.67; 0.86-4.48 (95% Confidence interval)) and estimating one's child as rather healthy (B 0.27; 0.19-0.34) and negative associations with social and emotional strains (B -3.50; -5.11- -1.88), obesity (B -2.56; -4.69- -0.42), having experienced a C-section (B -1.73; -3.23- -0.23), a positive history of somatic diseases (B -2.14; -3.53- -0.74), parental stress (B -0.39; -0.66- -0.11) and education of more than ten years (B -2.42; -3.95- -0.90). Maternal physical health status showed significant negative associations with age (B -0.13; -0.25- -0.01), employment before maternity leave (B -1.90; -3.59- -0.21), social and emotional strains (B -1.50; -2.67- -0.34), parental stress (B -0.28; -0.45- -0.12), C-section (B -4.06; -5.12- -2.99), having the first child (B -2.03; -3.09- -0.97) and a history of somatic diseases (B -2.00; -2.99- -1.01). Maternal mental health status showed significant positive associations with education of more than 10 years (B 2.27; 0.98-3.56) and a high level of social support (B 1.20; 0.06-2.34), while social and emotional strains (B -4.16; -5.48- -2.84) and parental stress (B -0.70; -0.92- -0.47) were negatively associated. CONCLUSIONS: We identified important protective factors for maternal health four weeks after delivery, such as a high level of social support. However, parental stress and social and emotional strains in particular seem to have a negative influence on maternal health. These findings have public health relevance.

Evaluation of Undescended Testes in Newborns: It Is Really Simple, Just Not Easy.

INTRODUCTION: The evaluation of the testicular position in newborns is important to ensure timely initiation of therapy. The aim of our study was to assess the reliability of a routinely performed screening examination. PATIENTS AND METHODS: Newborns were examined by a pediatrician between 48 and 72 h after birth. Boys with suspected cryptorchidism were double-checked by a pediatric urologist within 24 h. RESULTS: 1,181/2,353 children included in the study between June 2015 and December 2017 were male. Eight hundred sixty-one boys could be included in this analysis; 5.8% (n = 50) were diagnosed with undescended testis (UDT) by the pediatrician. 30/50 boys were double-checked at the Department of Pediatric Urology. Forty percent (20/50) were lost to follow-up. In 43% (13/30), the diagnosis could be confirmed. Three former studies had shown a relevant discrepancy in the results of the diagnosis of UDT made by health care providers and urologists/pediatric surgeons. To our knowledge, this is the first study evaluating the testicular position in male newborns in such a large prospective birth cohort study by physicians with ranging expertise within 1 day. CONCLUSION: Further treatment for UDT is based on clinical examination. Ours and previous studies can clearly show the various findings in boys suspected having UDT. Therefore, it is essential that the diagnosis is confirmed by a specialist before a therapy is initiated.

Breastfeeding behavior is not associated with health literacy: evidence from the German KUNO-Kids birth cohort study.

PURPOSE: Despite the health benefits of full breastfeeding for both infants and mothers, less than 50% of mothers in Germany practice this method for at least 4 months after childbirth. Because of the growing importance of health literacy to improve public health, we investigated the role of maternal health literacy in breastfeeding behavior. METHODS: We analyzed the data of 1172 mother-child dyads of the KUNO-Kids health study of the University Children's and Maternity Hospital Regensburg. Maternal health literacy was assessed with the HLS-EU-Q47 questionnaire (sub-index health care) up to 48 h after childbirth. Outcome was analyzed 6 months after childbirth and categorized into full breastfeeding for less than 4 months or for at least 4 months. The association between breastfeeding and maternal health literacy was calculated with univariable and multivariable logistic regression analyses. RESULTS: 38.8% of mothers showed inadequate or limited health literacy. 75.9% of mothers had fully breastfed their child for at least 4 months. Univariable logistic regression analysis showed that health literacy and full breastfeeding for at least 4 months were not associated (OR = 0.995 [CI 0.977-1.015], p = 0.60). After adjusting for all potentially confounding variables with a significant association (p ≤ 0.05) on both health literacy and breastfeeding, the multivariable model showed no association between health literacy and breastfeeding (OR = 0.984 [CI 0.963-1.007], p = 0.170). CONCLUSION: Surprisingly, we found no association between health literacy and breastfeeding behavior in our study. Therefore, future research with comparable measurements of health literacy and breastfeeding is required to validate this result and to identify reasons for early breastfeeding cessation.

Successful containment of Covid-19 outbreak in a large maternity and perinatal center while continuing clinical service.

With increasing number of SARS-CoV-2 infections and COVID-19 patients to be taken care of by the health system, more and more health workers become affected by the disease. It has been reported that right from the beginning of the outbreak in Lombardy up to 20% of the doctors and nurses became infected. Under these circumstances, the regular operation of health institutions already suffering from a shortage of staff becomes difficult. This has led to complete or partial shutdowns of hospitals, either due to a lack of uninfected personnel or because of uncontrollable chains of infection endangering patients. In one of the largest university perinatal center in Bavaria with more than 3000 births per year, an outbreak of COVID-19 occurred in March 2020, affecting 36 staff members, including doctors, nurses, and midwives. Here, we describe the outbreak and present the measures contributing to the successful containment of the outbreak within three weeks. At the same time, clinical services could be maintained, however, not without deployment of personnel exposed to employees infected with SARS-CoV-2. Apart from massive testing of personnel in pre-defined phases and increased hygiene measures, including a general obligation to wear surgical face masks, we identified the need to monitor cases of illness across all groups of employees, to ensure social distancing within personnel and to evaluate contacts of clinical personnel outside of the hospital environment, in order to be able to interpret chains of infections and to disrupt them. Overall, only a bundle of measures is needed to contain such an outbreak.

Symptoms and immunoglobulin development in hospital staff exposed to a SARS-CoV-2 outbreak.

BACKGROUND: Worldwide, the number of SARS-CoV-2 infections is increasing. Serological immunoglobulin tests may help to better understand the development of immune mechanisms against SARS-CoV-2 in COVID-19 cases and exposed but asymptomatic individuals. The aim of this study was to investigate exposure to SARS-CoV-2, symptoms, and antibody responses in a large sample of healthcare workers following a COVID-19 outbreak. METHODS: A COVID-19 outbreak among staff members of a major German children's and women's hospital was followed by massive RT-PCR SARS-CoV-2 tests and provided the opportunity to study symptoms, chains of infection, and SARS-CoV-2-specific antibody responses (IgG and IgA) by ELISA. Study participants were classified as COVID-19 cases, and persons with close, moderate, or no exposure to SARS-CoV-2 in the clinical setting, respectively. RESULTS: Out of 201 study participants, 31 were COVID-19 cases. While most study participants experienced many symptoms indicative for SARS-CoV-2 infection, anosmia and coughing were remarkably more frequent in COVID-19 cases. Approximately 80% of COVID-19 cases developed some specific antibody response (IgA and IgG) approximately 3 weeks after onset of symptoms. Subjects in the non-COVID-19 groups had also elevated IgG (1.8%) and IgA values (7.6%) irrespective of contact history with cases. CONCLUSION: We found that a significant number of diseased did not develop relevant antibody responses three weeks after symptom onset. Our data also suggest that exposure to COVID-19 positive co-workers in a hospital setting is not leading to the development of measurable immune responses in a significant proportion of asymptomatic contact persons.