Clinical efficacy and satisfaction of a digital wheeze detector in a multicentre randomised controlled trial: the WheezeScan study.

Introduction: Wheezing is common in preschool children and its clinical assessment often challenging for caretakers. This study aims to evaluate the impact of a novel digital wheeze detector (WheezeScan™) on disease control in a home care setting. Methods: A multicentre randomised open-label controlled trial was conducted in Berlin, Istanbul and London. Participants aged 4-84 months with a doctor's diagnosis of recurrent wheezing in the past 12 months were included. While the control group followed usual care, the intervention group received the WheezeScan™ for at-home use for 120 days. Parents completed questionnaires regarding their child's respiratory symptoms, disease-related and parental quality of life, and caretaker self-efficacy at baseline (T0), 90 days (T1) and 4 months (T2). Results: A total of 167 children, with a mean±sd age of 3.2±1.6 years, were enrolled in the study (intervention group n=87; control group n=80). There was no statistically significant difference in wheeze control assessed by TRACK (mean difference 3.8, 95% CI -2.3-9.9; p=0.2) at T1 between treatment groups (primary outcome). Children's and parental quality of life and parental self-efficacy were comparable between both groups at T1. The evaluation of device usability and perception showed that parents found it useful. Conclusion: In the current study population, the wheeze detector did not show significant impact on the home management of preschool wheezing. Hence, further research is needed to better understand how the perception and usage behaviour may influence the clinical impact of a digital support.

Orally applied bacterial lysate in infants at risk for atopy does not prevent atopic dermatitis, allergic rhinitis, asthma or allergic sensitization at school age: Follow-up of a randomized trial.

BACKGROUND: The allergy preventive effects of gut immune modulation by bacterial compounds are still not fully understood. OBJECTIVE: We sought to evaluate the effect of bacterial lysate applied orally from the second until seventh months of life on the prevalence of allergic diseases at school age. METHODS: In a randomized, placebo-controlled trial, 606 newborns with at least one allergic parent received orally a bacterial lysate consisting of heat-killed Gram-negative Escherichia coli Symbio and Gram-positive Enterococcus faecalis Symbio or placebo from week 5 until the end of month 7. A total of 402 children were followed until school age (6-11 years) for the assessment of current atopic dermatitis (AD), allergic rhinitis (AR), asthma and sensitization against aeroallergens. RESULTS: AD was diagnosed in 11.0% (22/200) of children in the active and in 10.4% (21/202) of children in the placebo group. AR was diagnosed in 35% (70/200) of children in the active and in 38.1% (77/202) children in the placebo group. Asthma was diagnosed in 9% (18/199) of children in the active and in 6.6% (13/197) of children in the placebo group. Sensitization occurred in 46.5% (66/142) of participants in the active and 51.7% (76/147) in the placebo group. CONCLUSION: An oral bacterial lysate of heat-killed Gram-negative Escherichia coli and Gram-positive Enterococcus faecalis applied during the first 7 months of life did not influence the development of AD, asthma and AR at school age.

Elevated blood eosinophils in early infancy are predictive of atopic dermatitis in children with risk for atopy.

BACKGROUND: Accessible markers to predict the development of atopic diseases are highly desirable but yet matter of debate. OBJECTIVE: We investigated the role of blood eosinophils at 4 weeks and 7 months of life and their association with developing atopic dermatitis (AD) in a birth cohort of children with atopic heredity. METHODS: Infant blood samples for eosinophil counts were taken from 559 infants at 4 weeks and from 467 infants at 7 month of life with at least one atopic parent. Elevation of blood eosinophils was defined as ≥ 5% of total leukocytes and the asscociation for the occurrence of AD was assessed by entering 2 × 2 tables and the odds ratios were estimated followed by hypothesis testing against the alternate working hypothesis: odds ratio < > 1. Survival analysis was carried out estimating the Kaplan-Meier product limit estimator from the life-time table of AD score and time to AD manifestation stratified by the eosinophil binary score. RESULTS: Elevated blood eosinophils observed at 4 weeks were significantly associated with the occurrence of AD in the whole cohort at the age of 7 months (p = 0.007), 1 year (p = 0.004), 2 years (p = 0.007) and 3 years (p = 0.006) of life. AD occurred app. 12 weeks earlier in infants with elevated blood eosinophils at 4 weeks of life. Blood eosinophil counts ≥5% at 7 months of life failed to show significance for AD; for eosinophils at 4.5% a significant association at 7 months (p = 0.005), and 1 year of life (p = 0.039), 2 years (p = 0.033) and 3 years (p = 0.034) was observed. CONCLUSION: Elevated blood eosinophils at age 4 weeks have a predictive value for the onset of atopic dermatitis in infancy and early childhood in children with high risk for atopy. Early eosinophil counts may therefore be helpful for counseling parents to provide infant skincare but furthermore identify individuals for interventional trials aiming at allergy prevention.

Oral application of bacterial lysate in infancy decreases the risk of atopic dermatitis in children with 1 atopic parent in a randomized, placebo-controlled trial.

BACKGROUND: Lower prevalence of atopy was found in children with continuous exposure to livestock and thus to microbial compounds. In animal models exposure to endotoxin (LPS) decreases allergic sensitization and airway inflammation. OBJECTIVE: We sought to evaluate the effect of orally applied bacterial lysate in infancy on the prevalence of atopic dermatitis (AD) after the treatment phase at 7 months of age. METHODS: This randomized, placebo-controlled trial included 606 newborns with at least single heredity for atopy. From week 5 until the end of month 7, infants were treated orally with bacterial lysate containing heat-killed gram-negative Escherichia coli Symbio and gram-positive Enterococcus faecalis Symbio or its placebo. Children were followed until 3 years of age. RESULTS: There was no difference in the primary outcome between the active and placebo groups in the total study group. AD prevalence was significantly reduced at the end of the intervention phase (31 weeks of age) in the subgroup of infants with single heredity for atopy (relative risk, 0.52; 95% CI, 0.3-0.9). Ten percent (15/154) of infants in the active group had AD compared with 19% (27/145, P = .030) in the placebo group. This was more pronounced in the group of infants with paternal heredity for atopy (11% vs 32%, P = .004; relative risk, 0.34; 95% CI, 0.2-0.7). CONCLUSION: Feeding of bacterial lysate might have prevented the development of AD, especially in children with paternal atopy, possibly indicating a preventive property only in subjects with a limited risk for atopy.