FreshRSS

🔒
❌ Acerca de FreshRSS
Hay nuevos artículos disponibles. Pincha para refrescar la página.
AnteayerTus fuentes RSS

Study of topical anaesthetic for paediatric laser procedures (STAPLE): a protocol for a feasibility and pilot randomised controlled trial

Por: Shilova · M. · Plummer · K. · Ware · R. S. · Kimble · R. · Griffin · B.
Introduction

Cutaneous vascular anomalies and scars can cause significant physical and psychosocial difficulties for children, but can be ameliorated with pulsed dye laser (PDL) and neodymium-doped yttrium aluminium garnet (Nd:YAG) laser treatment. Given that multiple rounds of treatment are often required, and that the procedures are painful, achieving adequate analgesia is imperative in this setting. Paediatric procedural pain management guidelines suggest that multimodal non-pharmacological and pharmacological analgesia should be used for such procedures; however, the place of topical anaesthetic (TA) within this paradigm has not been adequately studied.

This feasibility and pilot trial will investigate the feasibility of performing a randomised, placebo-controlled trial assessing pain intensity in children receiving TA in conjunction with other multimodal analgesic methods for laser procedures. The primary objective of the trial will be to assess feasibility, and secondary objectives will be to assess pain intensity, acceptability of trial procedures to participating families and their clinical team, to assess the laser treatment response, and obtain data necessary for full-scale trial sample size calculations.

Methods and analysis

The trial will include 50 children aged 0–18 years old who are undergoing awake PDL and/or Nd:YAG laser treatment for scars or vascular anomalies. Patients will be randomised in a 1:1 ratio to receive either TA cream (lidocaine 2.5%/prilocaine 2.5% (Numit 5% cream, Ego Pharmaceuticals, Braeside, VIC, Australia)) or a placebo, along with our unit’s standard multimodal analgesic agents for laser treatment (including paracetamol, ibuprofen or oxycodone and intraprocedural sucrose solution or intranasal fentanyl). Investigators, participants and their caregivers, and clinicians will be blinded to participant allocation.

The primary outcome of the trial will be trial feasibility based on pre-specified criteria. The secondary outcome of pain intensity will be assessed by observer, caregiver and self-reported measures, and the secondary outcome of trial method acceptability with a Theoretical Framework of Acceptability questionnaire. The assessment of laser treatment response will be assessed with lesion-specific evaluation tools. Feasibility and acceptability data will be summarised using descriptive statistics. The association between treatment groups and pain scores, treatment groups and laser treatment response will be investigated using a univariable linear regression model, with the effect estimate reported as mean difference and 95% CI.

Ethics and dissemination

This trial has undergone ethical review and has been granted approval by the Children’s Health Queensland Hospital and Health Service Human Research Ethics Committee (ref HREC/23/QCHQ/91002) and the Griffith University Human Research Ethics Committee (ref 2023/308). The protocol has been prospectively registered in the Australian and New Zealand Clinical Trials Registry (ACTRN12623000494639). Results of this trial may be presented at scientific meetings and will be published in a peer-reviewed journal. Participating families that have indicated an interest in trial results will receive a plain-language summary of the trial results by email.

Trial registration number

ACTRN12623000494639.

Dementia and Mild Cognitive Impairment in Prison (DECISION) care pathway and training package: protocol for a realist-informed mixed-methods feasibility study

Por: Forsyth · K. · Buck · D. · Stalker · K. · Allgar · V. · Shaw · J. · Cowley-Sharp · R. · Hunter · R. · Lennox · C. · ONeill · A. · Robinson · C. · Ware · S. · Robinson · L.
Introduction

Recent research indicates that around 8% of older people living in prison have signs or symptoms of dementia or mild cognitive impairment (MCI), yet the care they receive is not equivalent to care in the community and this means their needs may not be met. We co-developed an intervention specifically for older people living in prison with dementia/MCI (Dementia and Mild Cognitive Impairment in prison care pathway and training package–DECISION). To date, this has not been implemented or evaluated. This paper presents our protocol for a study to assess the feasibility and acceptability of DECISION.

Methods

This is a non-randomised, realist-informed mixed-methods feasibility study with integrated process evaluation, which will take place in two prisons in England. The intervention was codeveloped with experts with lived experience. Participants will include older people living in prison, staff working in prison and peer supporters. We will assess the feasibility and acceptability of the intervention (eg, numbers eligible; rates of recruitment and retention), and the evaluation design (eg, completion rates of standardised outcome measures). Methods will include semistructured, realist-informed interviews; an audit to assess implementation fidelity; focused ethnography; training questionnaires; and collection of resource use data. We will refine the DECISION programme theory using realist-informed methods to examine and refine how contexts and mechanisms interact to produce the intervention’s outcomes.

Ethics and dissemination

This study received a favourable ethical opinion from the Wales REC 3 Research Ethics Committee in January 2025 (reference number 24/WA/0323). HMPPS National Research Committee approval was also granted in January 2025 (reference number 2024-1451). Findings will be disseminated through a range of avenues, including stakeholder engagement events, open-access papers, conference presentations, evidence briefings for commissioners, providers and practitioners, and newsletters for service users.

Understanding the impact of temporary childbirth migration on maternal and child health: study protocol of a community-based prospective cohort study in India

Por: Patil · R. · El Ayadi · A. M. · Tonde · K. · Choudhari · B. · Bhujbal · S. · Murro · R. · Agarwal · D. · Charlebois · E. · Bansal · P. · Nitnaware · N. · Kalantri · A. · Mundra · A. · Goyal · N. · Raut · A. · Rongsen-Chandola · T. · Juvekar · S. K. · Diamond-Smith · N.
Introduction

Temporary childbirth migration (TCM), where women return to their natal homes for pregnancy, delivery or postpartum for a limited duration, is a long-standing sociocultural practice in India. While often motivated by familial support and traditional norms, its implications for maternal and child health and health system engagement remain poorly understood. This study aims to quantify the impact of TCM on maternal and newborn outcomes and to explore how continuity of perinatal care and social support mediate these relationships.

Methods and analysis

We are conducting a three-site, community-based, prospective cohort study across the Health and Demographic Surveillance System sites of Vadu (Maharashtra), Sevagram (Maharashtra) and DEESHA (Delhi). A total of 3000 pregnant women will be enrolled in pregnancy (

Ethics and dissemination

This study has been approved by the Ethics committees at the KEM Hospital Research Centre Pune (KEMHRC/RVM/EC/1931), Society for Applied Studies (SAS/ERC/TCM Study/2024), Mahatma Gandhi Institute of Medical Sciences (MGIMS/lEC/COMMED/8412023) and University of California San Francisco (22-36484). All research activities are conducted in accordance with Indian Council of Medical Research Guidelines for biomedical research and the Declaration of Helsinki. On study completion, findings will be disseminated to diverse local, national and global stakeholders and published in academic journals.

Trial registration number

CTRI/2024/02/062881.

Establishing the prevalence of fetal alcohol spectrum disorder among young people in Youth Justice residences in Aotearoa, New Zealand: a study protocol

Por: Chu · J. T. W. · McCormack · J. C. · McGinn · V. · Bullen · C. · Gibbs · A. · Seaford · A. · Ware (Ngapuhi) · F. · Mutch · R. · Jones · H. · Umali · E. · Gardiner · C. · Wilson · H. · Moki · H. · Faiai · A. · Parag · V. · Newcombe · D.
Introduction

Fetal alcohol spectrum disorder (FASD) is a diagnostic term that describes the neurodevelopmental and physical effects resulting from prenatal exposure to alcohol. Individuals living with FASD can experience lifelong challenges, yet with a diagnosis and sufficient support for the individual and their whānau (families), people can live fulfilling lives. Currently, little is known of the prevalence and impact in Aotearoa, New Zealand (NZ). Our aim is to identify the prevalence and understand the needs of young people living with FASD and other neurodevelopmental disorders in Youth Justice (YJ) residences in Aotearoa, NZ. One study will investigate the prevalence of FASD in this setting. The outcomes of both studies may demonstrate barriers and enablers, as well as strengths and gaps in YJ services of Aotearoa, NZ. The outcomes of both studies may guide reinforcing of current best practices as well as highlight necessary and novel initiatives together providing best support for the children and adolescents and their whānau as well as staff across YJ residences.

Methods and analysis

Extensive consultation with Māori and Pacific Advisory groups, researchers and experts in FASD and justice settings, individuals living with FASD and YJ staff together informed the development of this study.

Children and adolescents (hereafter young people) aged 10 to 18 years and currently residing in YJ residences are eligible for participation and assessment for FASD through assenting and consenting to provide personal and social histories and completed physical and neuropsychological assessments. The comprehensive FASD histories, screening and assessment will be conducted by a neuropsychologist and paediatrician employing standardised assessment practices and instruments. The team will also collect information from health, education and care and protection records; from the young people themselves; and from their family and staff. The study will reference Whakakotahitanga, the newly released (2024) guidelines for screening and diagnosing FASD in Aotearoa, NZ while also acknowledging the differences imposed under constraints of funding research including, for example, time and money. An individualised report will be prepared for each young person and their whānau. Study data will be analysed with descriptive statistics as appropriate. Our findings will be considered by the Māori and Pasifika advisory groups for framing and culturally secure translation, disseminated with all participating young people, translated to YJ services and staff, government and community neurodiversity sectors. Outcomes will be made available through community hubs, conferences, reports and peer-reviewed journal publications.

Ethics and dissemination

The study has received ethical approval from the Southern Health and Disability Ethics Committee (2024 Full 20065). Locality ethical approval has been granted from Oranga Tamariki (Ministry of Children), and a privacy impact evaluation has been undertaken. The findings will be shared through peer-reviewed publication, local and national conferences and with key agencies including Oranga Tamariki.

❌