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In a placebo-controlled, phase 2–3 trial, one dose of mRNA-1345 led to a lower incidence of RSV disease among adults 60 years of age or older. Solicited local and systemic adverse reactions occurred more often with the vaccine.

An RSV prefusion F maternal vaccine was assessed for efficacy against RSV disease in infants. The trial was stopped early owing to a higher incidence of preterm birth in the vaccine group than in the placebo group.

In this multicenter, randomized trial involving women at high risk for late preterm delivery, administration of betamethasone significantly reduced the rate of neonatal respiratory complications. Antenatal glucocorticoids are widely used in obstetrics for pregnancies at risk for early preterm delivery. Their use increased especially after a consensus conference held by the National Institutes of Health in 1994, which concluded that there was strong evidence that glucocorticoids reduce adverse neonatal outcomes, including death, the respiratory distress syndrome, and other complications, when administered to women who are likely to deliver before 34 weeks of gestation. 1 – 3 The recommendation was not extended to women at risk for preterm delivery after 34 weeks because of both a lack of data 4 , 5 and the belief that at a threshold of . . .

AbstractObjectiveTo assess the efficacy of a single preoperative physiotherapy session to reduce postoperative pulmonary complications (PPCs) after upper abdominal surgery.DesignProspective, pragmatic, multicentre, patient and assessor blinded, parallel group, randomised placebo controlled superiority trial.SettingMultidisciplinary preadmission clinics at three tertiary public hospitals in Australia and New Zealand.Participants441 adults aged 18 years or older who were within six weeks of elective major open upper abdominal surgery were randomly assigned through concealed allocation to receive either an information booklet (n=219; control) or preoperative physiotherapy (n=222; intervention) and followed for 12 months. 432 completed the trial.InterventionsPreoperatively, participants received an information booklet (control) or an additional 30 minute physiotherapy education and breathing exercise training session (intervention). Education focused on PPCs and their prevention through early ambulation and self directed breathing exercises to be initiated immediately on regaining consciousness after surgery. Postoperatively, all participants received standardised early ambulation, and no additional respiratory physiotherapy was provided.Main outcome measuresThe primary outcome was a PPC within 14 postoperative hospital days assessed daily using the Melbourne group score. Secondary outcomes were hospital acquired pneumonia, length of hospital stay, utilisation of intensive care unit services, and hospital costs. Patient reported health related quality of life, physical function, and post-discharge complications were measured at six weeks, and all cause mortality was measured to 12 months.ResultsThe incidence of PPCs within 14 postoperative hospital days, including hospital acquired pneumonia, was halved (adjusted hazard ratio 0.48, 95% confidence interval 0.30 to 0.75, P=0.001) in the intervention group compared with the control group, with an absolute risk reduction of 15% (95% confidence interval 7% to 22%) and a number needed to treat of 7 (95% confidence interval 5 to 14). No significant differences in other secondary outcomes were detected.ConclusionIn a general population of patients listed for elective upper abdominal surgery, a 30 minute preoperative physiotherapy session provided within existing hospital multidisciplinary preadmission clinics halves the incidence of PPCs and specifically hospital acquired pneumonia. Further research is required to investigate benefits to mortality and length of stay.Trial registrationAustralian New Zealand Clinical Trials Registry ANZCTR 12613000664741.

Influenza has been an acknowledged cause of respiratory disease for decades. However, considerable related, and often unappreciated, disease burden stems from cardiovascular complications, exacerbations of underlying medical conditions and secondary respiratory complications, with the highest burden in the elderly. This novel study combines the gold standard method of a randomized controlled trial with real-world data collection through national registries, to assess the relative effectiveness of high-dose (QIV-HD) vs standard-dose quadrivalent influenza vaccine (QIV-SD) in preventing cardio-respiratory hospitalizations in a large cohort of adults aged ≥65 years. This trial (NCT04137887) is a Phase III/IV, modified double-blinded, randomized, registry-based trial, conducted by the Finnish Institute for Health and Welfare (THL). Participants (n>120 000) are being enrolled over multiple influenza seasons and randomized (1:1) to receive QIV-HD or QIV-SD. Participant follow-up is based on data collection up to 11 months post-vaccination using Finnish national health registries. The primary objective is to demonstrate the relative superior effectiveness of QIV-HD over QIV-SD in preventing cardio-respiratory hospitalizations up to 6 months post-vaccination. Safety will be assessed using automated online tools throughout the study, with causality assessed using statistical and probabilistic methods; serious adverse reactions and adverse events of special interest will be investigated individually. This large, real-world, randomized study will provide valuable insight into the contribution of influenza in causing severe cardio-respiratory events, and the role of vaccination with QIV-HD in reducing these outcomes compared to the current standard of care. Sanofi Pasteur QIV-HD, high-dose quadrivalent influenza vaccine; QIV-SD, standard-dose quadrivalent influenza vaccine [Display omitted]

Exposure to biomass smoke has been related to adverse health effects. In Mexico, one household in four still cooks with biomass fuel, but there has been no evaluation of the health impact of reducing indoor air pollution. To evaluate the health impact of the introduction of an improved biomass stove (Patsari; Interdisciplinary Group for Appropriate Rural Technology [GIRA], Patzcuaro, Mexico) in Mexican women. A randomized controlled trial was conducted in the Central Mexican state of Michoacán. Households were randomized to receive the Patsari stove or keep their traditional open fire. A total of 552 women were followed with monthly visits over 10 months to assess stove use, inquire about respiratory and other symptoms, and obtain lung function measurements. Statistical analysis was conducted using longitudinal models. Adherence to the intervention was low (50%). Women who reported using the Patsari stove most of the time compared with those using the open fire had significantly lower risk of respiratory symptoms (relative risk [RR], 0.77; 95% confidence interval [CI], 0.62-0.95 for cough and RR, 0.29; 95% CI, 0.11-0.77 for wheezing) adjusted for confounders. Similar results were found for other respiratory symptoms as well as for eye discomfort, headache, and back pain. Actual use of the Patsari stove was associated with a lower FEV(1) decline (31 ml) compared with the open fire use (62 ml) over 1 year of follow-up (P = 0.012) for women 20 years of age and older, adjusting for confounders. The use of the Patsari stove was significantly associated with a reduction of symptoms and of lung function decline comparable to smoking cessation.

Background/Objectives: To determine the impact of a not hydrolyzed fermented infant formula containing heat-killed Bifidobacterium breve C50 and Streptococcus thermophilus 065 (HKBBST) on the incidence of allergy-like events during the first 2 years of life in children at high risk of atopy. Subjects/Methods: This multicenter, randomized, double-blind, controlled study included infants at high risk of atopy. Infants used HKBBST or a standard infant formula (SIF) since birth until 1 year of age, and were followed at 4, 12 and 24 months after birth. Skin prick tests (SPTs) for six foods and six aeroallergens were systematically performed and adverse events (AEs) were recorded. In case of potentially allergic AE (PAAE), allergy could be further tested by SPT, patch tests and quantification of specific IgEs. If cow's milk allergy (CMA) was suspected, an oral challenge could also be performed. Results: The study included 129 children, 63 were randomized to SIF, 66 to HKBBST. The use of HKBBST milk did not alter the proportion of CMA but decreased the proportion of positive SPT to cow's milk (1.7 vs 12.5%, P=0.03), and the incidence of digestive (39 vs 63%, P=0.01) and respiratory potentially allergic AEs (7 vs 21%, P=0.03) at 12 months, and that of respiratory PAAEs at 24 months (13 vs 35%, P=0.01). Conclusions: HKBBST decreased the incidence of PAAEs in children with family history of atopy, during the first months of life and after the formula was stopped. Oral tolerance to cow's milk in infants at high risk of atopy may therefore be improved using not hydrolyzed fermented formulae.

The potential for transmission of infectious diseases offered by the school environment are likely to be an important contributor to the rates of infectious disease experienced by children. This study aimed to test whether the addition of hand sanitiser in primary school classrooms compared with usual hand hygiene would reduce illness absences in primary school children in New Zealand. This parallel-group cluster randomised trial took place in 68 primary schools, where schools were allocated using restricted randomisation (1:1 ratio) to the intervention or control group. All children (aged 5 to 11 y) in attendance at participating schools received an in-class hand hygiene education session. Schools in the intervention group were provided with alcohol-based hand sanitiser dispensers in classrooms for the winter school terms (27 April to 25 September 2009). Control schools received only the hand hygiene education session. The primary outcome was the number of absence episodes due to any illness among 2,443 follow-up children whose caregivers were telephoned after each absence from school. Secondary outcomes measured among follow-up children were the number of absence episodes due to specific illness (respiratory or gastrointestinal), length of illness and illness absence episodes, and number of episodes where at least one other member of the household became ill subsequently (child or adult). We also examined whether provision of sanitiser was associated with experience of a skin reaction. The number of absences for any reason and the length of the absence episode were measured in all primary school children enrolled at the schools. Children, school administrative staff, and the school liaison research assistants were not blind to group allocation. Outcome assessors of follow-up children were blind to group allocation. Of the 1,301 and 1,142 follow-up children in the hand sanitiser and control groups, respectively, the rate of absence episodes due to illness per 100 child-days was similar (1.21 and 1.16, respectively, incidence rate ratio 1.06, 95% CI 0.94 to 1.18). The provision of an alcohol-based hand sanitiser dispenser in classrooms was not effective in reducing rates of absence episodes due to respiratory or gastrointestinal illness, the length of illness or illness absence episodes, or the rate of subsequent infection for other members of the household in these children. The percentage of children experiencing a skin reaction was similar (10.4% hand sanitiser versus 10.3% control, risk ratio 1.01, 95% CI 0.78 to 1.30). The rate or length of absence episodes for any reason measured for all children also did not differ between groups. Limitations of the study include that the study was conducted during an influenza pandemic, with associated public health messaging about hand hygiene, which may have increased hand hygiene among all children and thereby reduced any additional effectiveness of sanitiser provision. We did not quite achieve the planned sample size of 1,350 follow-up children per group, although we still obtained precise estimates of the intervention effects. Also, it is possible that follow-up children were healthier than non-participating eligible children, with therefore less to gain from improved hand hygiene. However, lack of effectiveness of hand sanitiser provision on the rate of absences among all children suggests that this may not be the explanation. The provision of hand sanitiser in addition to usual hand hygiene in primary schools in New Zealand did not prevent disease of severity sufficient to cause school absence. Australian New Zealand Clinical Trials Registry ACTRN12609000478213. Please see later in the article for the Editors' Summary.

Gut microbes have a substantial influence on systemic immune function and allergic sensitisation. Manipulation of the gut microbiome through prebiotics may provide a potential strategy to influence the immunopathology of asthma. This study investigated the effects of prebiotic Bimuno-galactooligosaccharide (B-GOS) supplementation on hyperpnoea-induced bronchoconstriction (HIB), a surrogate for exercise-induced bronchoconstriction, and airway inflammation. A total of ten adults with asthma and HIB and eight controls without asthma were randomised to receive 5·5 g/d of either B-GOS or placebo for 3 weeks separated by a 2-week washout period. The peak fall in forced expiratory volume in 1 s (FEV1) following eucapnic voluntary hyperpnoea (EVH) defined HIB severity. Markers of airway inflammation were measured at baseline and after EVH. Pulmonary function remained unchanged in the control group. In the HIB group, the peak post-EVH fall in FEV1 at day 0 (−880 (sd 480) ml) was unchanged after placebo, but was attenuated by 40 % (−940 (sd 460) v. −570 (sd 310) ml, P=0·004) after B-GOS. In the HIB group, B-GOS reduced baseline chemokine CC ligand 17 (399 (sd 140) v. 323 (sd 144) pg/ml, P=0·005) and TNF-α (2·68 (sd 0·98) v. 2·18 (sd 0·59) pg/ml, P=0·040) and abolished the EVH-induced 29 % increase in TNF-α. Baseline C-reactive protein was reduced following B-GOS in HIB (2·46 (sd 1·14) v. 1·44 (sd 0·41) mg/l, P=0·015) and control (2·16 (sd 1·02) v. 1·47 (sd 0·33) mg/l, P=0·050) groups. Chemokine CC ligand 11 and fraction of exhaled nitric oxide remained unchanged. B-GOS supplementation attenuated airway hyper-responsiveness with concomitant reductions in markers of airway inflammation associated with HIB.

β-(1,3/1,4)-glucan is a major component of cereal grains, such as oats and barley. In this study, we investigated the effects of cooked waxy barley, which contains β-(1,3/1,4)-glucan, on upper respiratory tract physical symptoms and mood status by performing a randomized, parallel-group, comparative trial. The primary outcome was assessed using the Wisconsin Upper Respiratory Symptom Survey-21 and Profile of Mood States second edition. Twenty-seven healthy Japanese adult participants were supplemented with 100 g of cooked waxy barley (containing 1.8 g of β-glucan) or 100 g of cooked white rice daily for 8 weeks. Participants receiving cooked waxy barley reported a reduction in cumulative days of sneezing (p < 0.05) and feeling tired (p < 0.0001) compared with the control group. After the intervention period, there were significantly less severe nasal symptoms, such as runny nose, plugged nose, and sneezing (p < 0.05), and a significantly greater reduction of the Tension-Anguish score (p < 0.05) in the barley group than in the control group. This study suggests that supplementation of cooked waxy barley containing β-(1,3/1,4)-glucan prevents or alleviates nasal upper respiratory tract symptoms and improves mood status. The findings of this study should be confirmed by double-blind trials with a larger number of participants.