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Cleft@18-23 study research clinics: a protocol for a multicentre observational study across UK cleft centres to understand variation in outcomes at the end of routine cleft care

Por: Vadlamudi · A. · van Eeden · S. · Spry · J. · Humphries · K. · Roosbey · A. · Baxter · E. · Leary · S. · Wren · Y.
Introduction

Cleft lip and/or palate (CL/P) is a lifelong condition affecting one in 700 births. In the UK, individuals born with CL/P follow a care pathway at specialist regional cleft centres, which includes input from a range of professionals including surgeons, speech and language therapists, cleft specialist nurses, orthodontists, dentists and clinical psychologists. The cleft centres provide care from diagnosis to early adulthood. Individuals born with CL/P are typically discharged from routine care at their cleft centre between the ages of 15 and 25 years.

Outcome measures of cleft care are currently gathered at different timepoints across the treatment pathway nationally and include outcomes for speech, growth, dental health and psychosocial well-being. However, there is no consistent reporting of outcomes for young adults when they complete routine care, meaning we do not know whether variation in outcomes exists and what this might look like.

This research programme will investigate whether outcomes vary based on factors such as geographical location, biological sex, socioeconomic status or ethnicity. By understanding how outcomes might vary, and the scale and type of variation, we plan to work with young adults born with CL/P and specialist clinicians to develop ways to ensure that everyone born with CL/P in the UK receives the optimum care to meet their needs.

Methods and analysis

Cleft@18–23 is an observational study of young adults born with CL/P. Recruitment is planned across all regions of the UK, beginning in April 2025 with research clinics scheduled to run between June 2025 and May 2027. The recruitment target is 640 participants born with CL/P. Participants with all cleft diagnoses, including those with additional syndromic diagnoses, will be eligible for recruitment. We will recruit participants from all ethnic and socioeconomic backgrounds. Data collection will include self-report participant questionnaires, speech samples, a hearing screen, two-dimensional and three-dimensional medical photographs, an intraoral scan and a dental assessment. A range of descriptive and inferential statistical analyses will explore variation in outcomes across different groups.

Ethics and dissemination

The Cleft@18–23 study obtained ethical approval from the South West-Frenchay Research Ethics Committee on 26 November 2024 (REC reference: 24/SW/0128). Informed consent will be required for participation. Findings from the Cleft@18–23 study will be disseminated through peer-reviewed publications, conference presentations, newsletters, the study website (https://www.bristol.ac.uk/cleft18-23) and social media.

Trial registration number

ISRCTN34027276.

Treatment and monitoring of a high-density population of bare-nosed wombats for sarcoptic mange

by Tanya N. Leary, Lyn Kaye, Olivia Chin, Kar Yee Phoon, David Phalen

Sarcoptes scabiei causes a fatal disease (mange) in bare-nosed wombats (BNWs) (Vombatus ursinus) across their range and can threaten isolated populations with extinction. Repeated dosing of moxidectin (Cydectin®) at a dosage rate of 0.5 mg/kg is effective at treating individual BNWs but is difficult to administer on a population basis where treatment success has varied. This paper documents the temporary (~20 month) eradication of mange from a semi-isolated population of BNWs using repeated dosing of Cydectin® administered by burrow flaps. Treated BNWs were marked with nontoxic paint and selected burrows were monitored with camera traps demonstrating that 64–96% of wombats in the population were treated with each dosage. Treatment success was attributed to the installation of burrow flaps on all burrows in the treated area. This treatment program shows that isolated high-density populations can be successfully treated for S. scabiei infection with repeated dosages of Cydectin® (0.5 mg/kg) and questions the need for higher dosages that have been advocated. Mange returned to the population of BNWs after 20 months possibly as the result of migration of an infected BNW from a nearby population, suggesting mange affected populations may require periodic retreatment. Monitoring of burrow entrances confirmed that burrows provide habitat used by many species of birds, reptiles, and mammals, and suggest burrows could be occasional sites of mange spillover among species. Camera trap monitoring also showed when BNWs in this population leave and return to their burrows; how many BNWs enter a burrow and explore the burrow entrances each night; and how these parameters are impacted by season and mange status; variables that are valuable to know when treating populations of BNW for mange.

From bedside to bug side: clinical, haematological and genetic markers of antibiotic-resistant bacterial isolates from children admitted with sepsis in Kaduna State, Nigeria - a protocol for a cross-sectional study

Por: Musa · S. · Aliyu · S. · Abdullahi · N. B. · Khalid · H. L. · Salihu · S. K. · Dahiru · A. U. · Muhammad · A. A. · Abdullahi · K. · Salisu · S. · Gumbi · S. A. · Tanko · Z. L. · Umaru · H. M. · Bello-Manga · H. · Dogara · L. G. · Musa · A. · Usman · I. K. · Lawal · U. W. · Cleary · D. W.
Introduction

Sepsis and antibiotic resistance constitute a deadly synergy, causing the loss of millions of lives across the world, with their economic and developmental consequences posing a threat to global prosperity. Their impact is disproportionately felt in resource-limited settings and among vulnerable populations, especially children. A key challenge is prompt diagnosis and timely commencement of appropriate antibiotic therapies. These challenges are compounded in low-income and middle-income countries by a lack of comprehensive epidemiological data, with Nigeria being one such country for which it is lacking. Kaduna is the third largest state in Nigeria, with over 10 million inhabitants, of whom more than half are children under 14 years old. While bacterial sepsis and antimicrobial resistance (AMR) are recognised as a growing problem in the state, there are huge gaps in the current understanding of their aetiology. This project employs a cross-sectional design to investigate the clinical and haematological markers of paediatric sepsis, alongside determining the bacterial cause and prevalence of AMR at four high-turnover hospitals in Kaduna State, Nigeria. Further, whole-genome sequencing of isolated bacterial pathogens will be performed to determine the genetic features of resistance. This project represents the largest surveillance study of paediatric sepsis in Kaduna to date. Additionally, we aim to use the clinical, haematological, microbiological and genomic data to derive predictive models for sepsis causes, treatment strategies and patient outcomes.

Methods and analysis

This is a hospital-based, cross-sectional study that will recruit up to 461 children with bacterial sepsis who were admitted at the two teaching and two general hospitals in Kaduna State, Nigeria. Children presenting with features of fever, subnormal temperature and body weakness would be recruited into the study and have their blood samples collected. The blood samples will be used for culture, complete blood count, HIV and malaria testing. Accordingly, we will capture clinical presentation, haematological characteristics, causative pathogen from blood culture and patient outcomes. Nutritional status, known congenital immunosuppressive diseases, HIV infection and malaria infection will also be determined and documented. The bacterial isolates will be phenotypically characterised for AMR and genotypically following whole genome sequencing. Known and potential confounders to the outcomes of bacterial sepsis would be assessed in all participants, and adjustment for confounding would be performed using logistic regression and/or stratification±Mantel-Haenszel estimator where applicable.

Ethics and dissemination

Ethical approvals were granted by the University of Birmingham (ERN_2115-Jun2024), the Ahmadu Bello University Teaching Hospital (ABUTHZ/HREC/H45/2023), Barau Dikko Teaching Hospital, Kaduna (NHREC/30/11/21A) and the Kaduna State Ministry of Health (MOH/AD M/744/VOL.1/1110018). The study will be conducted using the international guidelines for good clinical practice and based on the principles of the Declaration of Helsinki. The results will be disseminated via oral and poster presentations in scientific conferences and published in peer-reviewed journal articles.

Constructive Resistance: Essential to Optimise Workplace Quality

Journal of Advanced Nursing, Volume 81, Issue 10, Page 6071-6073, October 2025.
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