Adolescents experiencing emotional distress are at increased risk of developing mental health problems, which can negatively impact their academic performance, social relationships and long-term well-being. Schools provide a key setting for implementing preventive interventions that promote emotional and psychological resilience. This study presents the protocol for a randomised controlled trial designed to evaluate the effectiveness of a multicomponent, school-based intervention grounded in emotional intelligence (EI) in improving mental well-being, EI levels and resilience among adolescents aged 14–16 years experiencing emotional distress.

The trial will be conducted in public and publicly funded secondary schools in Terrassa, Spain, during the 2025–2026 academic year. Eligible participants will be identified using the short version of the Warwick-Edinburgh Mental Well-Being Scale (WEMWBS). The intervention consists of nine 55-minute group sessions delivered during school hours by a nurse and a physiotherapist, supported by the school’s psychopedagogue. Sessions focus on emotional regulation, self-esteem, mindfulness, assertiveness and other socio-emotional skills. Assessments will be conducted at baseline, postintervention and 24-week follow-up. The primary outcome is mental well-being (WEMWBS); secondary outcomes include EI (Trait Meta-Mood Scale-24 items) and resilience (Child and Youth Resilience Measure-32 items). It is anticipated that adolescents in the intervention group will show significantly greater improvements in mental well-being, emotional intelligence and resilience compared with the control group, with effects sustained at follow-up. This study will provide evidence on the effectiveness of a scalable, school-based intervention led by community health professionals. The programme could be integrated into educational and public health strategies to promote adolescent mental health and reduce emotional distress.

Approved by CEIm Consorci Sanitari de Terrassa (01-24-1CR-102). Low-risk study; predefined procedures are in place for participants at risk (eg, suicidal ideation, abuse) with referral pathways to health/social services. Findings will be disseminated via peer-reviewed publications, conferences and a plain-language summary to schools/stakeholders.

NCT06713460.

Neurodevelopmental impairments in congenital heart disease (CHD) are the most frequent long-term morbidity. Adverse neurodevelopmental outcomes may start in the prenatal period. Maternal mental health may be a potentially modifiable risk factor for the optimisation of neurodevelopment in CHD. We propose to assess the impact of prenatal maternal mental health on 1-year neurodevelopmental outcomes in complex CHD.

Neuro-Moms CHD is a national multi-centre, prospective study of prenatal maternal mental health and neurodevelopmental outcomes in children with complex CHD who undergo neonatal open-heart surgery. Participants (n=87 mother-child dyads) will be recruited from five major French paediatric cardiology centres (Necker Children’s Hospital in Paris, Bordeaux Cardiology Hospital, Marseille Children’s Hospital, Montpellier University Hospital and Saint-Pierre Institute). Expecting women who receive a prenatal diagnosis of fetal complex cyanotic CHD that requires a neonatal open-heart surgery for the newborn are eligible to participate. They will complete self-reports on mental health, anxiety, depression and coping skills and will participate in a semi-structured psychological interview. Mothers will provide information on medical, sociodemographic and lifestyle factors. They will be enrolled during the third trimester of pregnancy and will participate at three time points: prenatal, T1; after the newborn’s cardiac surgery, T2; and between 12 and 18 months after birth of the child with CHD, T3. Children with CHD will undergo a standardised neurodevelopmental assessment when they turn 12–18 months old. The father or co-parent of the child with CHD will also participate in T1 and will complete mental health self-reports. We will use a structural equation model to estimate simultaneously the relationships among maternal mental health, prenatal factors and child neurodevelopment outcomes.

This study is sponsored by the French National Institute of Health and Medical Research. It was approved by the Ethics Committee on 5 November 2024 and is registered in a public trials registry (NCT06711666). Neuro-Moms CHD targets a public health question with important societal implications. Results are expected to be broadly communicated with the scientific community and the lay public. Dissemination of findings will be in the form of scientific articles in peer-reviewed journals and presentations at conferences. Any publication or communication will comply with the international recommendations: ‘Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly work in Medical Journals’ (http://www.icmje.org/recommendations). All participants will give written informed consent or assent to participate. The anonymised data to be collected in this study will be available within the manuscripts published.

NCT06711666; pre-results.

Streptococcus pneumoniae serotype 3 (SPN3) remains a significant contributor to invasive pneumococcal disease globally, despite its inclusion in widely administered vaccines. The next generation of pneumococcal vaccines may confer better protection against this serotype, reducing disease burden. We describe an ethically approved protocol for a double-blind randomised controlled trial assessing the impact of VAXNEUVANCE (15-valent pneumococcal conjugated vaccine (PCV15)) and 0.9% saline (placebo) on the acquisition, density and duration of SPN3 carriage using a controlled human infection model.

Healthy adults aged 18–50 years will be randomised 1:1 to receive PCV15 or placebo. Participants will be considered enrolled on the trial at vaccination. One month following vaccination, all participants will be intranasally inoculated with SPN3. Following inoculation, participants will be followed up on days 2, 7, 14 and 28 to monitor safety, SPN3 colonisation status, density and duration, as well as immune responses. The primary endpoint of the study is to assess the rate of SPN3 acquisition between vaccinated and unvaccinated participants defined by classical microbiological methods. Secondary endpoints will determine the density and duration of SPN3 colonisation and compare the immune responses between study groups. An exploratory cohort of 5 participants will be asked to consent to a nasal biopsy procedure during a screening visit and a second nasal biopsy 28 days after PCV15 vaccination. This cohort will only receive PCV15 and will not be challenged. Through this exploratory cohort, we will explore gene expression changes induced by PCV15 vaccination and their visualisation (spatial location) within the nasal tissue.

This protocol has been reviewed by the sponsor, funder and external peer reviewers. The study is approved by the NHS Research and Ethics Committee (Reference: 24/SC/0388) and by the Medicines and Healthcare Products Regulatory Agency (Reference: CTA 21584/0485/001-0001).

NCT06731374 – ISRCTN91656864.

Pre-eclampsia (PEC) is a morbid and potentially lethal complication of pregnancy and is more common in women with risk factors such as hypertension, diabetes, autoimmune disease, kidney disease or multifetal pregnancies. Low dose aspirin (ASA) is currently the only prophylactic therapy known to decrease PEC in this patient population. However, currently, there is no prospective literature comparing various low-dose ASA formulations in the risk reduction of PEC. In the USA, the currently available low-dose ASA is over-the-counter and found in 81 mg tablets. Therefore, when clinicians initiate low-dose ASA therapy, they may prescribe one or two tablets of 81 mg per day without comparative evidence to guide their decision. Our objective is to prospectively compare pregnant patients on 81 mg vs 162 mg of ASA and determine a possible dose response in the prevention of PEC.

We designed a pragmatic phase 3 prospective randomised open label blinded-end point clinical trial with parallel assignment between two groups of pregnant people at high risk for PEC, as defined by the US Preventive Services Task Force and American College of Obstetricians and Gynecologists (ACOG). The primary outcome is the incidence of preterm (

Our research protocol and safety monitoring protocol have been approved by the Weill Cornell Medicine institutional review board (IRB) and the Office of Human Research Protection. Evaluation for adverse events will be monitored throughout the study period. Adverse events will be assessed at each study visit.

NCT04070573

COVID-19 in children is generally of short duration, but some may take longer to recover. This study investigated the time to symptom resolution following SARS-CoV-2 infection among children in a community setting on the outskirts of an urban centre in Brazil.

Prospective cohort study.

This is a community-based cohort of children living in Manguinhos, a favela in Rio de Janeiro. The cohort was followed through home visits and telephone monitoring of symptoms. The analysis focused on symptomatic children from this cohort with confirmed SARS-CoV-2 infection. Recovery time was defined as the interval between the first date with symptoms and the first date without symptoms following a positive SARS-CoV-2 test.

A total of 1276 children (boys and girls aged 2–

COVID-19 recovery time, assessed based on change points on the symptom persistence probability curve (Kaplan-Meier).

Among children who tested positive, 148 (60%) were symptomatic. The median recovery time was 11 days (IQR: 7–16). Two inflection points were identified on the Kaplan-Meier curve: days 16 and 34. Children who were ill during the Omicron wave took longer to recover. More boys became asymptomatic within the first 15 days; about 93% of girls recovered by day 33, and boys were more common among those who recovered in ≥34 days. Children aged 6–

Among children from a vulnerable area in Rio de Janeiro, recovery time was longer than that reported in other countries, with 9.5% of children experiencing persistent symptoms for more than 33 days. These findings are crucial for understanding the implications of COVID-19 in specific socioeconomic contexts and the dynamics of paediatric recovery in community settings.