Drug and vaccine safety information relevant to pregnant individuals is typically insufficient, especially so for persons living in low- and middle-income countries (LMICs). Pregnancy exposure registries (PERs) and similar systems are used to monitor medical products safety. A better understanding of the landscape of PERs in LMICs can support medicines regulatory system strengthening and preparation for new vaccine and drug introductions.

To identify PERs and related health data collection platforms in LMICs that systematically record pregnancy exposures to medical products and pregnancy outcomes to inform how future efforts, such as new vaccine introductions and treatment programmes, can better support maternal populations in these countries.

Scoping review based on methodology outlined in the Joanna Briggs Institute manual for scoping reviews.

Electronic search of Medline/PubMed, Embase, CINAHL and Global Index Medicus in June 2022, and key informants via online survey in July 2022 and interviews.

Eligible resources included registries, surveillance systems and databases that collect information on exposures to medical products during pregnancy and on subsequent maternal, perinatal and neonatal outcomes in populations located entirely or partially in LMICs. Eligible records were published from January 2000 through June 2022.

Search results were screened and data extracted using a standardised form by two independent reviewers. Instances of discordance were resolved by a third reviewer. Identified systems were categorised by resource type.

A total of 7515 records from electronic searches were screened, with 396 selected for full-text review and 47 additional records obtained from other sources. From these, 45 data collection systems located in African, Asian and Latin American LMICs were identified, with 36 currently in operation. These resources were grouped into six categories based on structure and approach and summarised according to key features, strengths and weaknesses.

This scoping review identified several resources in LMICs dedicated to drug and vaccine safety in pregnancy, but findings indicate that more investment will be needed to ensure such efforts are widespread and sustainable. Understanding the current landscape of such resources in these settings is an important step towards improving safe, world-wide access to life-saving interventions for pregnant populations.

The protocol for this review has been registered with Open Science Framework (https://doi.org/10.17605/OSF.IO/FU5AT).

Acute hypoxaemic respiratory failure is a common reason for intensive care unit (ICU) admission. Non-invasive respiratory support strategies such as high-flow nasal oxygen (HFNO) and helmet non-invasive ventilation may reduce the need for invasive mechanical ventilation and death. The High-flow nasal Oxygen with or without alternating helmet Non-invasive ventilation for Oxygenation sUpport in acute Respiratory failure pilot trial is designed to compare helmet non-invasive ventilation combined with HFNO vs HFNO alone in patients with acute hypoxaemic respiratory failure and to determine the feasibility of a larger randomised controlled trial.

This is a pragmatic, open-label, multicentre randomised controlled pilot trial enrolling 200 critically ill adults with acute hypoxaemic respiratory failure across 12 Canadian ICUs. Participants are randomised 1 to 1 to receive either helmet non-invasive ventilation plus HFNO or HFNO alone for at least 48 hours. The primary aim is to assess feasibility metrics including recruitment rate, protocol adherence and fidelity to pre-specified intubation criteria. Secondary outcomes include rates of intubation, all-cause mortality, ventilator-free days, ICU length of stay and quality of life at 6 months. Primary and secondary outcomes will be analysed using Bayesian methods.

Ethics approval has been obtained at all participating centres. Findings will inform the feasibility and design of a future full-scale trial and be disseminated through peer review publications and conference presentations.

ClinicalTrials.gov Identifier: NCT05078034.

Post-surgical care following cochlear implantation is a pivotal part of the rehabilitation journey for cochlear implant (CI) recipients. However, frequent in-clinic visits, particularly in the first year following CI activation, can place a significant burden on CI recipients. Moreover, the growing number of CI recipients may pose a challenge for CI clinics to provide consistent and lifelong care. Cochlear Remote Care is a platform that enables the delivery of post-surgical care through remote hearing assessments and remote video appointments, offering an opportunity to enhance clinic efficiency, eliminate geographical barriers, reduce financial burdens and provide flexible post-surgical options. The primary objective of this study is to compare self-reported hearing ability in daily life among CI recipients who receive post-surgical care through Remote Care with those receiving routine in-clinic care during the first year following CI activation. Additionally, the study will assess the time and costs associated with these care models for both the clinic and patients.

This multi-centre randomised controlled trial is set to be conducted across 11 clinics in the United Kingdom, Italy, the Netherlands, Belgium and Australia, with an anticipated sample size of 148 participants. All participants will be adults with post-lingual deafness and unilateral CIs. Following baseline measurements at 3 months post-activation, participants will be randomly assigned to either in-clinic visits or Remote Care appointments. At six and 12 months after activation, participants will complete a comprehensive battery of audiometric tests and questionnaires on patient-reported outcomes, usability and resource utilisation.

Ethics approval has been obtained for each clinical site. Study findings will be disseminated widely through peer-reviewed publications, lay language summaries and conference presentations.

NCT05552118.