Foveal avascular zone in adults born preterm with and without retinopathy of prematurity - results from the Gutenberg Prematurity Eye Study.

PURPOSE: To examine potential changes in the foveal avascular zone (FAZ) during adulthood due to prematurity and retinopathy of prematurity (ROP), as assessed by measurements of FAZ area and circularity. METHODS: The Gutenberg Prematurity Eye Study (GPES) is a retrospective German cohort study with a prospective ophthalmologic examination of adults aged 18 to 52 years, born either preterm or full-term, utilizing spectral-domain optical coherence tomography angiography. Participants were categorized into groups based on gestational age and postnatal ROP status. The study employed multivariable linear regression analyses to explore associations with the FAZ. RESULTS: The study cohort comprised 380 right eyes from individuals born both preterm and full-term, with an average age of 28.4 +/- 8.6 years, including 214 females. The FAZ area decreased as gestational age decreased: FAZ was 0.28 ± 0.12 mm2 (control group), 0.21 ± 0.10 mm2 at GA 33-36 weeks, 0.18 ± 0.10 mm2 at GA 29-32 weeks, 0.11 ± 0.10 mm2 at GA ≤28 weeks, 0.11 ± 0.10 mm2 in ROP without treatment, and 0.11 ± 0.10 mm2 in those requiring ROP treatment. In the multivariable analyses, smaller FAZ was independently associated with gestational age (p<0.05), increased foveal retinal thickness (<0.05), and foveal hypoplasia (p<0.05).Moreover, no association was seen between visual acuity and FAZ. CONCLUSION: The main perinatal factor associated with a smaller FAZ in this German cohort is preterm birth, while ROP, ROP treatment, or other perinatal factors do not affect FAZ observed in adulthood. A smaller FAZ shape in preterm individuals might be an indicator of foveal hypoplasia.

Teachers reported that children with special health care needs displayed more attention problems.

AIM: Children with special health care needs (SHCN) perform more poorly at school compared to their classmates. Specific causal pathways have not yet been extensively studied. Therefore, we investigated teacher-rated global attention, an important prerequisite for educational attainment, in children with SHCN. METHODS: Data of a population-based prospective cohort study, which recruited preschool children from the Mainz-Bingen area, Germany, were analysed. Children with SHCN were identified by the Children with Special Health Care Needs screening tool. In 2016, global attention was reported by teachers at the end of first grade (mean age: 7.3 years) on a 5-point rating scale ranging from -2 through +2. Associations between SHCN consequences and teacher-rated attention were estimated by linear mixed models, adjusted for confounding variables. RESULTS: We included 1921 children (51% males); of these, 14% had SHCN. Compared to their classmates, children with SHCN had poorer teacher-rated attention scores (adjusted mean difference: -0.35, 95% CI: -0.52 to -0.17). The effect was strongest among children with treatment or counselling for mental health problems or functional limitations. The effect remained after excluding children with attention deficit hyperactivity disorder from the analysis. CONCLUSION: Children with SHCN showed more teacher-rated attention problems, which could explain their lower educational attainment.

Value of a web-based pediatric drug information system to prevent serious adverse drug reactions in child and adolescent psychiatry.

Psychotropic drugs are frequently prescribed 'off-label' to children and adolescents and carry the risk of serious adverse drug reactions (sADR). We examined the frequency of sADRs of psychotropic drugs in pediatric inpatients and explored their potential preventability through following the recommendations of a web-based pediatric drug information system (PDIS). The potential socio-economic impacts of using this online system is also addressed. Routine clinical data from all inpatients treated in a child and adolescent psychiatry department between January 2017 and December 2018 were retrospectively examined for the occurrence of sADRs as defined by the European Medicines Agency. The preventability of the sADRs was assessed based on the information of the PDIS. Furthermore, the expected prolongation of the hospital stay due to sADRs was calculated as well as the associated treatment costs. The study was supported by the Innovation Fund of the Joint Federal Committee, grant number 01NVF16021. In total, 1036 patients were screened of whom 658 (63.5%) received psychopharmacological treatment. In 53 (8.1%) of these patients 54 sADRs were documented, of which 37 sADRs were identified as potentially preventable through PDIS. Mitigating sADR through PDIS would likely have prevented prolonged hospital stays and conferred considerable savings for health insurance companies. PDIS provides systematic and evidence-based information about pediatric psychopharmacotherapy and helps to prevent prescribing errors. Therefore, PDIS is a useful tool to increase drug therapy safety in child and adolescent psychiatry. Further prospective studies are needed to confirm the results.

Ophthalmologic Care of Former Preterm and Full-Term Infants during Their Childhood and Adolescence - A Retrospective View of Their Parents. / Augenärztliche Versorgung früh- und reifgeborener Personen in deren Kindheit und Jugend ­ eine retrospektive Sicht der Eltern.

BACKGROUND: The aim of the present study was to evaluate the ophthalmologic care in childhood and adolescence of infants born preterm and full-term from the retrospective point of view of their parents. METHODOLOGY: The Gutenberg Prematurity Eye Study (GPES) is a retrospective cohort study with a prospective ophthalmologic examination of persons born preterm and full-term between 1969 and 2002 (now aged 18 to 52 years), and asks their parents about the ophthalmologic care received by their children in childhood and adolescence from their retrospective perspective. Participants and their parents were grouped into those with normal gestational age (GA) ≥ 37 (control group), preterm born infants without retinopathy of prematurity (ROP) and gestational age (GA) 33 - 36 (group 2), GA 29 - 32 (group 3), GA ≤ 28 weeks (group 4), and those with ROP without treatment (group 5) and with ROP with treatment (group 6). Parents of participants were interviewed about the ophthalmic care received by their children. RESULTS: In total, data from 57 full-term and 131 preterm infants and their parents were included in the present study. The parents of the participants reported that ophthalmologic examination had taken place until 6 years of age in the respective groups 1 to 6 in 22/57 (38.6%), 33/58 (56.9%), 22/38 (57.9%), 3/6 (50%), 19/21 (90.5%), and 7/8 (87.5%). Overall, between 83% and 100% of parents in the different groups reported that ophthalmologic care had been adequate. A change of ophthalmologist due to dissatisfaction with treatment was reported by a total of 4/57 (7%), 9/58 (15.5%), 8/38 (21.1%), 1/6 (16.7%), 1/21 (4.8%) and 2/8 (25%) in the respective groups. DISCUSSION: The present study demonstrates adequate satisfaction and good treatment regarding ophthalmologic care of former preterm children from the parents' perspective. Especially parents of children with ROP rated the treatment positively.

RETINAL THICKNESS AND FOVEAL HYPOPLASIA IN ADULTS BORN PRETERM WITH AND WITHOUT RETINOPATHY OF PREMATURITY: The Gutenberg Prematurity Eye Study.

PURPOSE: This study analyses whether prematurity, retinopathy of prematurity (ROP), and associated factors lead to altered foveal shape in adulthood and whether these alterations are associated with visual acuity. METHODS: The Gutenberg Prematurity Eye Study is a German cohort study with a prospective ophthalmologic examination (participants aged 18-52 years) of individuals born preterm and full-term that were examined with spectral domain optical coherence tomography. Participants were grouped according to gestational age (GA) and postnatal ROP status. Multivariable linear regression analyses for foveolar retinal thickness, foveal hypoplasia, and posterior vitreous status were performed. RESULTS: A total of 755 eyes of 414 preterm and full-term individuals were included (aged 28.6 ± 8.6 years, 233 female individuals). Central foveal retinal thickness increased as GA decreased. The prevalence of foveal hypoplasia was 2% (control group), 9% (GA 33-36), 18% (GA 29-32), 48% (GA ≤28), 50% (ROP without treatment), and 82% of eyes (with ROP requiring treatment). In multivariable analyses, central foveal thickness was independently associated with GA and advanced stages of ROP requiring treatment while foveal hypoplasia was only associated with GA. Posterior vitreous was more frequently visible as partially detached in full-term than in preterm individuals. Lower distant-corrected visual acuity correlated with increased foveolar thickness (rho = 0.08; P = 0.03) and with foveal hypoplasia (rho = 0.15, P < 0.001). CONCLUSION: Our findings indicate that there are fetal origins affecting foveal shape, resulting in foveal hypoplasia potentially affecting the visual acuity in adulthood.

The role of preterm birth, retinopathy of prematurity and perinatal factors on corneal aberrations in adulthood: Results from the Gutenberg prematurity eye study.

INTRODUCTION: Prematurity and retinopathy of prematurity (ROP) are associated with altered corneal shape and reduced visual acuity in childhood, but their long-term effects on corneal shape in later life are still unclear. This study evaluated whether prematurity and related perinatal factors are associated with corneal aberrations in adulthood. METHODS: The Gutenberg Prematurity Eye Study (GPES) is a cohort study using Scheimpflug imaging of the cornea. Associations were assessed between corneal Zernike aberrations and gestational age (GA), birth weight (BW), BW percentile, ROP occurrence, ROP treatment and other perinatal factors using univariate and multivariable linear regression analyses. RESULTS: This study involved 444 eyes of 256 individuals born preterm (aged 28.1 ± 8.4 years, 146 females) and 231 eyes of 132 individuals born full-term (aged 29.8 ± 8.9 years, 77 females). Multivariable analyses revealed an association between corneal higher-order aberrations and lower birth weight percentile (B = -0.001, p < 0.001) as well as ROP treatment (B = 0.120, p = 0.03). Corneal lower-order aberrations were also associated with lower birth weight percentile (B = -0.004; p = 0.001) and ROP treatment (B = 0.838, p = 0.01) but not with ROP occurrence. Increased corneal aberrations were correlated with lower visual acuity and the spherical equivalent refractive error. CONCLUSIONS: Perinatal factors, particularly low birth weight percentile and ROP treatment lead to a more irregular corneal shape in adulthood, thereby reducing optical image quality and potentially contributing to reduced visual acuity and altered refractive error.

[Chronically ill at School - School Performance in Children with Special Health Care Needs. Results of the Child Health Study ikidS]. / Chronisch krank in der Schule ­ schulische Fähigkeiten von Kindern mit speziellem Versorgungsbedarf. Ergebnisse der Kindergesundheitsstudie ikidS.

BACKGROUND: The association between health status in childhood and later educational achievement is unknown. We describe the association between a chronic health condition (CHC) and school performance at the end of first grade. PATIENTS: As part of the child health survey ikidS, 2,003 preschoolers from the Mainz-Bingen area (Rhineland-Palatinate; Germany) were recruited. METHOD: In a prospective cohort study, children with CHC were identified by the children with special health care needs screener. At the end of first grade, classroom teachers evaluated the child's school performance on a rating scale ranging from - 2 through+2 in 5 domains: numeracy, science, reading, writing, and social competencies. Associations between special health care needs (SHCN) and each domain were assessed by linear mixed regression models adjusted for potential confounders. RESULTS: 1,463 children (51% males) were analyzed. Of these, 15% had SHCN. Compared to their classmates, children with SHCN performed poorer in numeracy (adjusted mean difference: - 0.40; 95% CI[- 0.57; - 0.23]) and writing (- 0.22; 95% CI[- 0.39; - 0.05]). DISCUSSION: For the first time in a German sample, we found an indication which educational competencies might be negatively impacted by SHCN early in school. This could have long-lasting effects on educational attainment and later socio-economic status. CONCLUSION: Our results question the uptake and/or effectiveness of existing medical care as well as educational support concepts for children with a CHC.

Age at school entry and reported symptoms of attention-deficit/hyperactivity in first graders: results of the prospective cohort study ikidS.

Young age at school entry (ASE) is related to attention-deficit/hyperactivity disorder in higher grades. The reason for this association is unclear, but medical oversupply and stress-related factors are discussed. We aimed to investigate whether ASE is associated with reported symptoms of attention-deficit/hyperactivity (ADH) already in first grade. Data of a population-based prospective cohort study (N = 2003; Mainz-Bingen region; Rhineland-Palatinate; Germany) with baseline assessments prior to school entry and two follow-ups during first grade were analysed. ADH symptoms were assessed by parent and teacher versions of the Strengths and Difficulties Questionnaire. Associations between ASE and scores of the hyperactivity/inattention subscale (range 0-10) were investigated by regression analysis and adjusted for potential confounders and baseline symptoms prior to school entry. In total, 1633 children (52% boys, mean ASE 6.5 years) were included. There were no relationships between ASE and parent-reported scores of the hyperactivity/inattention subscale prior to school entry and 3 months thereafter. However, at the end of first grade, ASE was negatively associated with the hyperactivity/inattention subscale in parent (- 0.7 subscale points per year ASE, standard error = 0.16, p < 0.0001) and teacher reports (- 1.2 subscale points per year ASE, standard error = 0.25, p < 0.0001). This ASE effect appeared more pronounced in girls than in boys. Young ASE is related to more reported symptoms of ADH at the end of first grade, but not before. The evolvement of this effect during first grade may be a clue to ASE-related stress factors.

Mental health and health-related quality of life in preschool-aged childhood cancer survivors. Results of the prospective cohort study ikidS-OEVA.

OBJECTIVES: Long-term survivors of childhood cancer are at increased risk for sequelae such as poor mental health (MH) or impaired health-related quality of life (HrQoL). We aimed to evaluate early adverse effects on MH and HrQoL in young childhood cancer survivors (YCCS) before school entry. METHODS: In a nationwide prospective cohort study, children with cancer other than brain tumors diagnosed at preschool age and completed cancer treatments were identified from the German Childhood Cancer Registry. The comparison group was children of the same age without a cancer diagnosis who participated in the prospective population-based health survey ikidS. MH problems and HrQoL were assessed by parental versions of the Strengths and Difficulties Questionnaire (SDQ) and the questionnaire for health-related quality of life in children (KINDL), respectively. Associations between cancer and MH as well as HrQoL were analyzed by multivariable linear regression. RESULTS: Of 382 YCCS contacted, 145 were enrolled (mean age 6.6 years) and 124 analyzed. Compared to children without a cancer diagnosis (3683 contacted, 2003 enrolled, 1422 analyzed), YCCS had more MH problems (13% vs. 3%) and slightly worse HrQoL (median 78.7 vs. 80.2 points). In the adjusted analysis, YCCS had higher SDQ scores (2.2 points, 95% confidence interval [CI] 1.3, 3.0) and lower KINDL scores (-2.4 points, 95% CI -3.7, -1.1) compared to children without cancer diagnosis. CONCLUSION: Already at preschool age, YCCS may be at increased risk of MH problems and impaired HrQoL. This could have impacts on subsequent school performance and educational attainment. Follow-up health care for YCCS may include early screening for MH problems and reasons for HrQoL deficits.

[Evaluation of the Language-related Domain of the Pediatric Developmental Screening Instrument for Preschool Health Examinations (SOPESS): Results from the Prospective Child Health Survey ikidS]. / Evaluation der Sprachaufgaben des sozialpädiatrischen Entwicklungsscreenings für Schuleingangsuntersuchungen (SOPESS): Ergebnisse der prospektiven Kindergesundheitsstudie ikidS.

PURPOSE OF THE STUDY: Developmental delays at school enrollment can affect early educational achievement. Thus, diagnosis and treatment prior to school entry are important. In Germany, SOPESS - a pediatric developmental screening instrument for preschool health examinations (PHE) - was introduced in several federal states. We investigated the relationships between the results of the language-related domain of the SOPESS and later academic language competencies at the end of first grade. PROCEDURES: Data of the population-based cohort study ikidS (Rhineland Palatinate; Germany) and the PHE provided by public health authorities were linked at individual level. The relationship between the SOPESS-language risk score (range: 0 to 6, higher values indicate more developmental delay) and class teacher-based ratings of academic language competencies (range: -4 to+4, higher values indicate better competencies) was investigated with linear regression models and adjusted for several socio-economic and medical language predictors (e. g. age at school entry, gender, parental education, migration background, hearing disorder). The additional benefits of the SOPESS-language risk score was analyzed using analysis of variance. RESULTS: In total, 1357 children (48% girls, age at PHE 4.9-7.2 years) were included. A clear negative relationship between the SOPESS-language risk score and competencies in spoken and written language was found. Mean academic language competencies decreased with increasing SOPESS-language risk level from 0.8 (SD=1.7) at a risk score of 0 to-3.2 (SD=0.9) at a risk score of 6. The relationship persisted after adjusting for other language predictors. Analysis of variance showed significant benefits of the SOPESS-language risk score, even when further language predictors were considered. CONCLUSIONS: There was a clear relationship between results of the SOPESS-language screening and later academic language competencies. Hence, the language-related domain of the SOPESS may be useful for further recommendations of tailored special educational and medical support services, especially if additional socio-economic and medical factors are considered.

Prevalence of Strabismus and Its Impact on Vision-Related Quality of Life: Results from the German Population-Based Gutenberg Health Study.

PURPOSE: This study investigates the prevalence of manifest strabismus and its subtypes in adulthood and analyzes the risk factors and its impact on vision-related quality of life (VRQoL). DESIGN: The Gutenberg Health Study (GHS) is a population-based, observational cohort study. A cross-sectional analysis of the baseline examination was conducted. PARTICIPANTS: Participants aged 35 to 74 years were included (n = 15 010). METHODS: All participants were examined with a comprehensive ophthalmologic and general examination including the Hirschberg corneal reflex test to detect manifest strabismus. The following risk factors were analyzed: age, sex, socioeconomic status, birth weight, maternal age at birth, anisometropia, astigmatism, spherical equivalent, low visual acuity in the worse seeing eye (≥1.3 logMAR), and cardiovascular factors, and included in multivariable logistic regression analysis. Lifetime period prevalence and point prevalence of manifest strabismus were computed, and VRQoL was compared between participants with and without strabismus. MAIN OUTCOME MEASURE: Strabismus prevalence. RESULTS: A total of 14 700 participants (age, 55.0±11.1 years; 49.5% were female) were included in this analysis. The weighted prevalence of ever having strabismus was 2.9% (2.6%-3.2%), and the point prevalence for concomitant strabismus was 2.5% (2.3%-2.8%). Esotropia was twice as frequent as exotropia, and 2 participants had paralytic strabismus. Concomitant strabismus was associated with age 65 to 69 years (odds ratio [OR], 0.13 [0.05-0.39], P < 0.001); age 70 to 74 years (OR, 0.14 [0.05-0.4], P < 0.001); anisometropia (>1.0 diopters [D]: OR, 3.61 [2.32-5.62], P < 0.001; >2.0 D: OR, 6.93 [4.23-11.35], P < 0.001); astigmatism (≥1.0 D: OR, 2.09 [1.42-3.08], P < 0.001; ≥2.0 D: OR, 3.74 [2.35-5.97], P < 0.001); spherical equivalent (per diopter: OR, 1.43 [1.33-1.53], P < 0.001); and low visual acuity in the worse seeing eye (≥1.3 logMAR: OR, 21.7 [11.2-42.0], P < 0.001). VRQoL was lower in participants with strabismus compared with participants without strabismus in adjusted analysis (B = -5.96, P < 0.001). CONCLUSIONS: Strabismus is a frequent chronic eye condition that is associated with a lower VRQoL. Individuals with anisometropia, astigmatism, and hyperopia are more likely to have strabismus. In addition, low visual acuity in the worse eye was linked to strabismus prevalence.

Anti-inflammatory medications for obstructive sleep apnoea in children.

BACKGROUND: Obstructive sleep apnoea (OSA) is characterised by partial or complete upper airway obstruction during sleep. Approximately 1% to 4% of children are affected by OSA, with adenotonsillar hypertrophy being the most common underlying risk factor. Surgical removal of enlarged adenoids or tonsils is the currently recommended first-line treatment for OSA due to adenotonsillar hypertrophy. Given the perioperative risk and an estimated recurrence rate of up to 20% following surgery, there has recently been an increased interest in less invasive alternatives to adenotonsillectomy. As the enlarged adenoids and tonsils consist of hypertrophied lymphoid tissue, anti-inflammatory drugs have been proposed as a potential non-surgical treatment option in children with OSA. OBJECTIVES: To assess the efficacy and safety of anti-inflammatory drugs for the treatment of OSA in children. SEARCH METHODS: We identified trials from searches of the Cochrane Airways Group Specialised Register, CENTRAL and MEDLINE (1950 to 2019). For identification of ongoing clinical trials, we searched ClinicalTrials.gov and the World Health Organization (WHO) trials portal. SELECTION CRITERIA: Randomised controlled trials (RCTs) comparing anti-inflammatory drugs against placebo in children between one and 16 years with objectively diagnosed OSA (apnoea/hypopnoea index (AHI) ≥ 1 per hour). DATA COLLECTION AND ANALYSIS: Two authors independently performed screening, data extraction, and quality assessment. We separately pooled results for the comparisons 'intranasal steroids' and 'montelukast' against placebo using random-effects models. The primary outcomes for this review were AHI and serious adverse events. Secondary outcomes included the respiratory disturbance index, desaturation index, respiratory arousal index, nadir arterial oxygen saturation, mean arterial oxygen saturation, avoidance of surgical treatment for OSA, clinical symptom score, tonsillar size, and adverse events. MAIN RESULTS: We included five trials with a total of 240 children aged one to 18 years with mild to moderate OSA (AHI 1 to 30 per hour). All trials were performed in specialised sleep medicine clinics at tertiary care centres. Follow-up time ranged from six weeks to four months. Three RCTs (n = 137) compared intranasal steroids against placebo; two RCTs compared oral montelukast against placebo (n = 103). We excluded one trial from the meta-analysis since the patients were not analysed as randomised. We also had concerns about selective reporting in another trial. We are uncertain about the difference in AHI (MD -3.18, 95% CI -8.70 to 2.35) between children receiving intranasal corticosteroids compared to placebo (2 studies, 75 participants; low-certainty evidence). In contrast, children receiving oral montelukast had a lower AHI (MD -3.41, 95% CI -5.36 to -1.45) compared to those in the placebo group (2 studies, 103 participants; moderate-certainty evidence). We are uncertain whether the secondary outcomes are different between children receiving intranasal corticosteroids compared to placebo: desaturation index (MD -2.12, 95% CI -4.27 to 0.04; 2 studies, 75 participants; moderate-certainty evidence), respiratory arousal index (MD -0.71, 95% CI -6.25 to 4.83; 2 studies, 75 participants; low-certainty evidence), and nadir oxygen saturation (MD 0.59%, 95% CI -1.09 to 2.27; 2 studies, 75 participants; moderate-certainty evidence). Children receiving oral montelukast had a lower respiratory arousal index (MD -2.89, 95% CI -4.68 to -1.10; 2 studies, 103 participants; moderate-certainty evidence) and nadir of oxygen saturation (MD 4.07, 95% CI 2.27 to 5.88; 2 studies, 103 participants; high-certainty evidence) compared to those in the placebo group. We are uncertain, however, about the difference in desaturation index (MD -2.50, 95% CI -5.53 to 0.54; 2 studies, 103 participants; low-certainty evidence) between the montelukast and placebo group. Adverse events were assessed and reported in all trials and were rare, of minor nature (e.g. nasal bleeding), and evenly distributed between study groups. No study examined the avoidance of surgical treatment for OSA as an outcome. AUTHORS' CONCLUSIONS: There is insufficient evidence for the efficacy of intranasal corticosteroids for the treatment of OSA in children; they may have short-term beneficial effects on the desaturation index and oxygen saturation in children with mild to moderate OSA but the certainty of the benefit on the primary outcome AHI, as well as the respiratory arousal index, was low due to imprecision of the estimates and heterogeneity between studies. Montelukast has short-term beneficial treatment effects for OSA in otherwise healthy, non-obese, surgically untreated children (moderate certainty for primary outcome and moderate and high certainty, respectively, for two secondary outcomes) by significantly reducing the number of apnoeas, hypopnoeas, and respiratory arousals during sleep. In addition, montelukast was well tolerated in the children studied. The clinical relevance of the observed treatment effects remains unclear, however, because minimal clinically important differences are not yet established for polysomnography-based outcomes in children. Long-term efficacy and safety data on the use of anti-inflammatory medications for the treatment of OSA in childhood are still not available. In addition, patient-centred outcomes like concentration ability, vigilance, or school performance have not been investigated yet. There are currently no RCTs on the use of other kinds of anti-inflammatory medications for the treatment of OSA in children. Future RCTs should investigate sustainability of treatment effects, avoidance of surgical treatment for OSA, and long-term safety of anti-inflammatory medications for the treatment of OSA in children and include patient-centred outcomes.

Beyond BMI: waist circumference and social environment is associated with motor performance ability in kindergartners.

BACKGROUND: The aim of the current study was to examine the relationship between anthropometric characteristics (i.e. body height, body weight, body mass index [BMI] and waist circumference [WC]) with motor performance ability [MPA], social environmental factors of the district (i.e. employment status/working life, education, social situation/heterogeneity and home environment), where the respective kindergarten was located, as well as other potential health determinants in a representative sample of kindergartners. METHODS: We analyzed data of 434 children aged 3 to 6 years which were obtained from a community-based cross-sectional health study conducted in the city of Mainz, Germany. Body height and weight, BMI and WC standard deviation scores [SDS] were calculated relative to the international proposed cut-offs of the IOTF. MPA was collected with multiple test items to determine coordination, speed strength, muscular endurance and speed. The life situation index [LSI] was used to assess the social environment of the district of the kindergarten. Adjusted for covariates, correlation and logistic regression analyses were conducted to estimate the effect of WC on MPA. RESULTS: Below-average MPA was found in 46% of the sample. While there was no relationship to BMI (odds ratio [OR]: 1.09, 95% confidence interval [95% CI]: 0.83-1.44; p = 0.538), WC SDS was positively associated with below-average MPA (OR: 1.41, 95% CI: 1.01-1.95; p = 0.041). Further results show that the social environment of the district of the kindergarten was independently related to below-average MPA (OR: 2.72, 95% CI: 1.29-5.75; p = 0.009). CONCLUSION: The findings suggest that WC rather than BMI is linked to measurements of MPA already in kindergartners and furthermore, there seems to be an independent association between MPA and the social environment of the district of the respective kindergarten.

Health-related quality of life and mental health in children and adolescents with strabismus - results of the representative population-based survey KiGGS.

BACKGROUND: To estimate the effect of strabismus (squinting) on mental health and health-related quality of life aspects in children and adolescents. METHODS: Data from the German Health Interview and Examination Survey for Children and Adolescents KiGGS (2003-2006 baseline survey; N = 14,835, aged 3 to 17 years, 49% girls) were examined. The presence of strabismus was derived by parental questionnaire, and health-related quality of life and mental health were investigated with the KINDL-R and Strengths and Difficulties Questionnaire. Associations between strabismus and outcomes were analyzed using multivariable linear and logistic regression models. RESULTS: Of 12,989 children without missing data, 579 children (4.5% of the sample) were reported to have strabismus. Children with strabismus had lower scores in the parent-reported KINDL-R total scale (adjusted beta = - 1.02; 95%CI: -1.86 to - 0.18; p = 0.018) and sub-scale 'friends' (adjusted beta = - 2.18; 95%CI: -3.56 to -0.80; p = 0.002) compared to children without strabismus. The presence of strabismus was also associated with more mental health problems like 'hyperactivity/inattention' (adjusted OR = 1.50; 95%CI: 1.14 to 1.98; p = 0.005), and 'peer problems' (adjusted OR = 1.35; 95%-CI: 1.05 to 1.74; p = 0.018) as reported by parents. CONCLUSIONS: Strabismus in children and adolescents is associated with lower health-related quality of life.

Measuring social participation in children with chronic health conditions: validation and reference values of the child and adolescent scale of participation (CASP) in the German context.

BACKGROUND: While ICF-CY-based models of care are promising avenues for improving participation of children with chronic health conditions, feasible and valid instruments to assess participation as an outcome in routine are still needed. We aimed to validate a German parent-report version of the Child and Adolescent Scale of Participation (CASP) in children with chronic health conditions of different severity. METHODS: Cross-sectional data were collected in 327 children (mean age 7.8 years, 55% boys) from two paediatric centres (n = 112) and one population-based sample (n = 215). Cronbach's alpha, factor analyses, face validity assessments, correlation analyses, receiver operating characteristics (ROC) curves, and parent-reported health-related quality of life (HRQoL: KINDL) were used to examine internal consistency, test-retest reliability, and capacity to differentiate between disease severity groups. Disease severity was operationalized according to ICD-diagnosis groups and/or parent-reports on health problems, medical and educational support, and medication. A newly developed item "overall perceived participation" was added to the CASP and evaluated. RESULTS: We found good to excellent content validity, excellent internal consistency, and good-to-excellent test-retest reliability of the instrument. While children with mild disease had a significantly greater extent of participation (higher CASP scores) than children with severe disease, they did not differ from healthy children. Children with mild compared to severe disease much more differed in participation as measured by the CASP compared to the KINDL (area under the ROC curve: 0.92 vs. 0.75). In addition, the item "overall perceived participation" was highly correlated (r = 0.86) with the CASP total score, indicating the potential value of this specific single item. Finally, we provided preliminary reference values for the CASP obtained in a population-based sample of children without chronic health conditions. CONCLUSIONS: The German version of the CASP and the new item are efficient, valid and reliable measures of social participation in childhood. The CASP-measured participation focuses more on attendance than on involvement into social circumstances of everyday life. To detect children with a high burden of disease on everyday life, the CASP may be more accurate than HRQoL instruments such as the KINDL. As outcome measurement, the CASP may facilitate the implementation of patient-centred paediatric health care.

Effects of closed-loop automatic control of the inspiratory fraction of oxygen (FiO2-C) on outcome of extremely preterm infants - study protocol of a randomized controlled parallel group multicenter trial for safety and efficacy.

BACKGROUND: Most extremely low gestational age neonates (ELGANS, postmenstrual age at birth (PMA) < 28 completed weeks) require supplemental oxygen and experience frequent intermittent hypoxemic and hyperoxemic episodes. Hypoxemic episodes and exposure to inadequately high concentrations of oxygen are associated with an increased risk of retinopathy of prematurity (ROP), chronic lung disease of prematurity (BPD), necrotizing enterocolitis (NEC), neurodevelopmental impairment (NDI), and death beyond 36 weeks PMA. Closed-loop automated control of the inspiratory fraction of oxygen (FiO2-C) reduces time outside the hemoglobin oxygen saturation (SpO2) target range, number and duration of hypo- and hyperoxemic episodes and caregivers' workload. Effects on clinically important outcomes in ELGANs such as ROP, BPD, NEC, NDI and mortality have not yet been studied. METHODS: An outcome-assessor-blinded, randomized controlled, parallel-group trial was designed and powered to study the effect of FiO2-C (in addition to routine manual control (RMC) of FiO2), compared to RMC only, on death and severe complications related to hypoxemia and/or hyperoxemia. 2340 ELGANS with a GA of 23 + 0/7 to 27 + 6/7 weeks will be recruited in approximately 75 European tertiary care neonatal centers. Study participants are randomly assigned to RMC (control-group) or FiO2-C in addition to RMC (intervention-group). Central randomization is stratified for center, gender and PMA at birth (< 26 weeks and ≥ 26 weeks). FiO2-C is provided by commercially available and CE-marked ventilators with an FiO2-C algorithm intended for use in newborn infants. The primary outcome variable (composite of death, severe ROP, BPD or NEC) is assessed at 36 weeks PMA (or, in case of ROP, until complete vascularization of the retina, respectively). The co-primary outcome variable (composite outcome of death, language/cognitive delay, motor impairment, severe visual impairment or hearing impairment) is assessed at 24 months corrected age. DISCUSSION: Short-term studies on FiO2-C showed improved time ELGANs spent within their assigned SpO2 target range, but effects of FiO2-C on clinical outcomes are yet unknown and will be addressed in the FiO2-C trial. This will ensure an appropriate assessment of safety and efficacy before FiO2-C may be implemented as standard therapy. TRIAL REGISTRATION: The study is registered at www.ClinicalTrials.gov: NCT03168516 , May 30, 2017.

Mental health problems and school performance in first graders: results of the prospective cohort study ikidS.

We aimed to estimate unbiased effects of mental health problems (MHPs) on school performance in first graders, with an emphasis on rigorous adjustment for potential confounders. A population-based prospective cohort study was performed in the area of Mainz-Bingen (Germany). In 2015, all preschoolers were approached, and the presence and type of MHP (externalising/internalising) and other physical chronic health conditions were identified by the preschool health examination and study-specific questionnaires. At the end of the first grade, school performance (reading, writing, numeracy, and science) was assessed by the class teacher and rated on a four-item scale ranging from - 8 to + 8. Of 3683 children approached, 2003 (54%) were enrolled. School performance was available for 1462 children (51% boys, mean age 7.3 years). Of these, 41% had signs of at least one MHP. Compared to children without indications of mental and physical chronic health conditions, children with MHPs had lower school performance scores [adjusted mean difference - 0.98, 95% CI (- 1.35; - 0.61); P < 0.001]. Regarding the type of MHP, externalising MHPs were associated with poor school performance [adjusted mean difference - 1.44, 95% CI (- 1.83; - 1.05); P < 0.001], while internalising MHPs were not. Children with hyperactivity inattention problems were most affected [adjusted mean difference - 1.96, 95% CI (- 2.36; - 1.56); P < 0.001]. Externalising MHPs and in particular hyperactivity inattention problems may already affect school performance in early primary school. Identification of children with externalising MHPs prior to school entry may help to prevent impaired academic achievement in affected children.

[Prevalence and Risk Factors of Myopia in Children and Adolescents in Germany - Results of the KiGGS Survey]. / Prävalenz und Risikofaktoren der Kurzsichtigkeit bei Kindern und Jugendlichen in Deutschland ­ Ergebnisse der KiGGS-Studie.

Purpose To determine the population prevalence and risk factors of myopia in children and adolescents in Germany. Methods The prevalence of myopia in Germany was computed using data from the 2003-2006 German Health Interview and Examination Survey for Children and Adolescents (N=17 640, 49% girls). Status of myopia was derived from parental questionnaire responses for myopia and the use of spectacles. Potential risk factors were identified using directed acyclic graphs and evaluated using multivariable logistic regression analysis. Results The population prevalence of myopia in the age group 3-17 years was estimated at 13.3% (95%-confidential interval 12.6-14.0%). In the age group 3-10 years, myopia was positively associated with age (per 2 years: OR=1.78 [1.59; 2.00]) and negatively associated with male gender (OR=0.73 [0.57; 0.95]), but neither with leisure-time activities nor with media use. In the age group 11-17 years, attending a High School was positively associated with myopia (OR=1.69 [1.32; 2.16]), while regular physical activity (OR=0.67 [0.53; 0.84]) was negatively associated. Media use was not associated. Conclusions In Germany, myopia is one of the most frequent chronic medical conditions among children and adolescents. Girls, adolescents, and pupils attending a Gymnasium are at higher risk of developing myopia while being physically active may be protective.

[Childhood strabismus in Germany: Prevalence and risk groups : Results of the KiGGS survey]. / Kindlicher Strabismus in Deutschland: Prävalenz und Risikogruppen : Ergebnisse der KiGGS-Studie.

OBJECTIVES: To estimate the prevalence of strabismus in children and adolescents in Germany and to determine the associated risk factors, particularly those related to early childhood development. METHODS: In the German Health Interview and Examination Survey for Children and Adolescents (KiGGS, baseline survey 2003 to 2006, N = 17,640, 49.1% girls), the presence of strabismus and potential risk factors were derived using parental questionnaires. The analyses were performed using the KIGGS public use file. The following relevant factors were analyzed: smoking during pregnancy, gestational age at birth, birth weight, medical problems within the first four weeks of life, and officially confirmed disability. Associations with strabismus were evaluated using multivariable logistic regression analysis. Odds ratios and 95% confidence intervals [95%-CI] were calculated and adjusted for age, sex, socio-economic status, migrational background, and participation in regular pediatric checkups. RESULTS: The prevalence of strabismus was estimated to be 4.1% [3.7-4.5]. Boys had a slightly lower prevalence (3.7%; [3.3-4.2%]) compared to girls (4.4%; [3.9-5.0%]; p value > 0.05). After adjusting for confounders, strabismus was found to be significantly associated with smoking during pregnancy (OR = 1.38; [1.08-1.78]), gestational age (OR = 0.91 per week; [0.86-0.96]), medical problems within the first four weeks of life (OR = 1.29; [1.01-1.65]) and disability (OR = 4.33; [2.81-6.67]), but not with other risk factors under study. CONCLUSIONS: In Germany, strabismus is among the most prevalent chronic eye conditions. Former preterm infants and disabled children and adolescents are at greater risk.

Effect of probiotics on vaginal health in pregnancy. EFFPRO, a randomized controlled trial.

BACKGROUND: Preterm delivery is a leading cause of neonatal morbidity and death. It often results from chorioamnionitis, which is a complication of bacterial vaginosis. Probiotics are effective in the treatment of bacterial vaginosis in women who were not pregnant; studies in pregnant woman are missing. OBJECTIVE: The purpose of this study was to evaluate whether an oral probiotic food supplement supports the maintenance or restoration of a normal vaginal microbiota during pregnancy. STUDY DESIGN: We conducted a randomized, placebo-controlled, triple-blind, parallel group trial. Oral Lactobacillus rhamnosus GR-1and L reuteri RC-14 (109 colony-forming units) or placebo were administered for 8 weeks to women with <12 completed weeks of pregnancy. Participants were enrolled at Tuebingen University Hospital and 10 recruiting gynecologic practices. Vaginal swabs were taken before and after intervention and analyzed according to the Nugent scoring system. Telephone interviews were performed before and after intervention and after delivery. Primary outcome was the proportion of swabs with normal Nugent score (<4) after intervention, compared by Fisher's exact test in an intention-to-treat analysis. RESULTS: Three hundred twenty pregnant women were enrolled. Vaginal swabs were analyzed from 290 women before and 271 women after intervention. The proportion of normal vaginal microbiota decreased from 82.6 to 77.8% in the treatment group and from 79.1 to 74.3% in the placebo group, with no significant difference across groups after intervention (P=.297). CONCLUSION: Oral probiotics may be suitable for implementation in antenatal care but, as administered here, had no effect on vaginal health during mid gestation. Other application routes or probiotic preparations may be more effective in supporting vaginal microbiota during pregnancy.