Neonatal haemochromatosis, considered to be a gestational alloimmune liver disease (NH-GALD), is a rare but serious disease that results in fulminant hepatic failure. The recurrence rate of NH-GALD in a subsequent infant of a mother with an affected infant is 70%–90%. Recently, antenatal maternal high-dose intravenous immunoglobulin (IVIG) therapy has been reported as being effective for preventing recurrence of NH-GALD in a subsequent infant. However, no clinical trial has been conducted to date.

This is a multicentre open-label, single-arm study of antenatal maternal high-dose IVIG therapy in pregnant women with a history of documented NH in a previous offspring. The objective of this study is to evaluate the efficacy and safety of antenatal maternal high-dose IVIG therapy in preventing or reducing the severity of alloimmune injury to the fetal liver.

The clinical trial is being performed in accordance with the Declaration of Helsinki. The trial protocol was approved by the Clinical Research Review Board at four hospitals. Before enrolment, written informed consent would be obtained from eligible pregnant women. The results are expected to be published in a scientific journal.

28 October 2024, V.8.0.

jRCT1091220353.

Colorectal cancer (CRC) is the third most common cancer and the second leading cause of cancer mortality worldwide. Despite the organised CRC screening programme, the uptake rate of the population-based CRC screening was still low. Thus, we will conduct a randomised controlled trial in a community setting to evaluate the effectiveness of a theory-based chatbot in promoting CRC screening uptake.

A total of 500 eligible participants will be randomly assigned to a WhatsApp Messenger-initiated chatbot outreach group or a standard text reminder group at a ratio of 1:1. The intervention group will deliver Chinese culturally tailored education texts and videos developed based on the Health Belief Model and the Trans-Theoretical Model. The control group will deliver a standard text reminder of information about the Hong Kong organised CRC screening programme. In addition to the baseline assessment and postintervention assessment, all subjects will be followed up for 3 months and 6 months, respectively. The primary outcome will be the CRC screening uptake rate at the 3 month and 6 month follow-up. The secondary outcomes will be the intention to undergo CRC screening uptake, time interval to participate in and complete screening after recruitment, and reasons for not participating in screening at the 3 month and 6 month follow-up. Quantitative data will be analysed using Student’s t-test, Pearson’s ² test or Fisher’s exact test. Qualitative data will be analysed by thematic analysis.

Ethical approval of this trial was granted by the Joint Chinese University of Hong Kong-New Territories East Cluster Clinical Research Ethics Committee (2022.614). Written informed consent will be obtained from study participants before enrolment. The findings will be disseminated through peer-reviewed journals.

The study was registered on clinicaltrials.gov (NCT06192862).

Around 80% of the world’s smokers live in lower-middle income countries and smoking rates in China, Philippines and Indonesia are very high. Evidence suggests that most people begin smoking or become habitual smokers before reaching adulthood. This highlights the need for a smoking prevention intervention focused on young people. ASSIST (A Stop Smoking In Schools Trial) is a ‘peer-led’, school-based smoking prevention intervention, shown to be effective in the UK. The aim of the study is to assess the feasibility of conducting a full-scale effectiveness evaluation of an adapted version of the ASSIST intervention in China, Indonesia or the Philippines. However, due to issues with obtaining relevant approvals, China was removed from the trial with the approval of the funder and Trial Steering Committee, and the study will only be completed in Indonesia and the Philippines.

A feasibility mixed-methods cluster randomised controlled trial in 10 schools (six intervention, four control) in each of the two countries. Participants will be students aged c13–14 in mainstream (‘lower secondary’) schools. In addition to their usual education on smoking, intervention schools will receive the ASSIST intervention which is based on ‘diffusion of innovation’ theory, with new norms and behaviours promoted through: (1) peer modelling by locally influential individuals; and (2) information disseminated by them through their social networks. Control schools will continue with their usual education around smoking prevention.

The key outcome of the study is whether prespecified progression criteria relating to recruitment, retention, acceptability and feasibility have been met in order to progress to a larger cluster randomised controlled effectiveness trial in one or more of the countries. A mixed-methods process evaluation will assess acceptability, feasibility and fidelity of intervention delivery, exposure to and reach of the intervention. The feasibility of trial processes including outcome measurement will be assessed. An economic evaluation will estimate the costs of the ASSIST intervention. Statistical analyses will focus on feasibility criteria, and qualitative data will be analysed using a framework approach. Outcomes assessed will include self-reported smoking behaviour (own and that of friends and family); vaping and other forms of nicotine use; smoking-related attitudes and knowledge; smoking norms; self-esteem; self-efficacy; (all at baseline and 7 month follow-up) and exhaled carbon monoxide concentration (at follow-up only).

The trial has been approved by the University of Glasgow College of Medical, Veterinary and Life Sciences (MVLS) Ethics Committee (ref: 200210204), the De La Salle University Research Ethics Review Committee (ref: 2023-012C) and the Medical and Health Research Ethics Committee (MHREC); Faculty of Medicine, Public Health and Nursing; Universitas Gadjah Mada (ref: KE/FK/1205/EC/2022). The trial is sponsored by the University of Glasgow (Head of Research Regulation and Compliance—debra.stuart@glasgow.ac.uk). The sponsor will not have input in data collection, management, analysis and interpretation; write up and submissions for publication.

The study findings will be disseminated through peer-reviewed publications in expert journals and conference presentations and targeted communications to schools, policymakers and the public.

ISRCTN99140476.

Critically ill patients in intensive care units (ICUs) receive life-sustaining treatments aimed at restoring or maintaining organ function. ICU admission often involves substantial multidimensional suffering that can burden patients, their families and surrogates. Multidisciplinary palliative care support can help alleviate their sufferings. In South Korea, however, palliative care has not yet been integrated into critical care settings, highlighting the need to explore the feasibility of its implementation within the ICU.

This study aims to test the feasibility of a consultation-based palliative care intervention in the ICU. The study will include 20 patients admitted to the ICU of a tertiary hospital due to sudden severe acute brain injury or progressive organ failure, along with their family caregivers. A palliative care team, comprising a social worker and a palliative care physician, will provide consultations to the ICU healthcare professionals based on the palliative care needs, following family counselling. Additional family meetings will be held if necessary. The primary outcomes will include participation rates, family counselling rates and study completion rates. The intervention’s potential impact will be assessed by changes in surrogate decision-making conflict, self-efficacy, depression and anxiety, post-decision regret and the experience of patient-centred and family-centred care. The demand and acceptability of the intervention will be assessed through semi-structured interviews with family surrogates, followed by qualitative analysis.

This study will be conducted in accordance with the Declaration of Helsinki and applicable national laws and regulations. The clinical study protocol, along with any protocol amendments and the informed consent form, has been approved by the Institutional Review Board of the Hospital (2404-111-1532). We plan to submit the study results for presentation at conferences and for publication in international peer-reviewed journals. Data will also be made available on request to participants, funding agencies and interested researchers.

NCT06490835.

Effective management of type 2 diabetes mellitus (T2DM) consists of lifestyle modification and therapy optimisation. While glycaemic monitoring can be used as a tool to guide these changes, this can be challenging with self-monitoring of blood glucose (SMBG). The FreeStyle Libre 3 (FSL3) is a real-time continuous glucose monitoring (CGM) system designed to replace SMBG. The evidence for the benefit of CGM in people with T2DM on non-intensive insulin regimens is limited. This study aims primarily to assess the glycaemic impact of FSL3 in people with suboptimally controlled T2DM treated with basal-only insulin regimens plus sodium-glucose cotransporter-2 (SGLT-2) inhibitor and/or glucagon-like peptide (GLP)-1 agonist.

This is an open-label, multicentre, parallel design, randomised (2:1) controlled trial. Recruitment has been offered across 24 clinical centres in the UK and nationally through self-referral. Adults with T2DM treated with basal-only insulin regimens plus SGLT-2 inhibitor and/or GLP-1 agonist and with screening HbA1c from ≥59 mmol/mol to ≤97 mmol/mol are included. Eligible participants will be randomised to either FSL3 (intervention) for 32 weeks or continuation of SMBG (control). The study is split into two phases, each of 16 weeks duration: phase 1 consisting of self-management with basal-insulin self-titration and phase 2 where additional therapies may be initiated. Control group participants may subsequently enter an optional extension phase to receive FSL3. The primary endpoint is the difference between treatment groups in mean change from baseline in HbA1c at 16 weeks. Secondary outcomes include HbA1c at 32 weeks, CGM-based metrics, therapy changes, physical activity levels and psychosocial measures. An economic evaluation for costs and patient outcomes will be undertaken.

The study was approved by the Health Research Authority, Health and Care Research Wales and the West Midlands-Edgbaston Research Ethics Committee (reference: 23/WM/0092). Study results will be disseminated in peer-reviewed journals.

NCT05944432.

Identifier assigned by the sponsor: ADC-UK-PMS-22057.

Revision D. Dated, 13 December 2024.

Factors associated with multimorbidity, polypharmacy and Medication Regimen Complexity Index (MRCI) may vary across countries. However, such data are lacking in the present study setting. This study aimed to identify factors associated with multimorbidity, polypharmacy and MRCI among adults living with hypertension in public hospitals of South Gondar Zone.

Multicentred cross-sectional design

Public hospitals of Comprehensive Specialised and Primary Hospitals, Ethiopia.

Adults living with hypertension who had follow-up visits at outpatient clinics and were selected by systematic random sampling from 1 December 2021 to 28 February 2022.

Medication regimen complexity was assessed using a 65-item medication regimen complexity tool. Sociodemographic data were collected through an interview, while polypharmacy and clinical characteristics were documented using a checklist. Data were entered into SPSS V.26 and analysed using STATA V.17. A binary logistic regression model was used to determine the AOR of factors associated with multimorbidity and polypharmacy. For factors influencing MRCI, an ordinal logistic regression was used.

We found participants from Nefas Mewucha Hospital (AOR = 0.3, 95% CI 0.15 to 0.59) and Mekane Eyesus Hospital (AOR = 0.17, 95% CI 0.07 to 0.38), compared with Debre Tabor Comprehensive Specialised Hospital, polypharmacy (AOR = 5.52, 95% CI 1.49 to 20.39), medium (AOR = 19.76, 95% CI 5.86 to 66.56) and high MRCI (AOR = 120.32, 95% CI 33.12 to 437.07) were associated with multimorbidity. Multimorbidity (AOR = 25.4, 95% CI 7.48 to 86.23), controlled blood pressure (AOR = 0.43, 95% CI 0.19 to 0.92) and duration of hypertension therapy 5 years or more (AOR = 2.12, 95% CI 1.08 to 4.16) were associated with polypharmacy. Whereas controlled BP (AOR = 0.48, 95% CI 0.32 to 0.72) and multimorbidity (AOR = 14.55, 95% CI 9.00 to 23.52) were significantly associated with high MRCI. The prevalence of multimorbidity, high MRCI and polypharmacy was found in 46.1%, 35.22% and 12.29% of participants, respectively.

A considerable proportion of participants with hypertension experienced multimorbidity, polypharmacy and high medication complexity. Polypharmacy, primary hospital setting and high MRCI were independent variables associated with multimorbidity. On the other hand, multimorbidity and controlled BP were associated with polypharmacy and MRCI. Hypertension care should consider multimorbidity, polypharmacy and medication complexity.

To estimate the recurrence of hypoglycaemia and the associated factors in neonates with birth asphyxia admitted to the neonatal intensive care unit in Northwest Amhara region’s comprehensive specialised hospitals, Northwest Ethiopia, in 2024.

A multicentre, institution-based, retrospective follow-up study.

Tertiary hospitals in Northwest Amhara Regional State, Northwest Ethiopia, from 1 July 2020 to 30 July 2024.

A total of 761 neonates with perinatal asphyxia were admitted to the neonatal intensive care unit of selected public hospitals in Northwest Amhara from July 2020 to July 2024.

The primary outcome measure of this study was recurrence of hypoglycaemia. Furthermore, the factors associated with recurrence of hypoglycaemia in newborns with perinatal asphyxia were noted.

The average number of hypoglycaemia cases among neonates with birth asphyxia was 2.05 (95% CI 1.939, 2.163) over the 28-day follow-up period. Meningitis (adjusted incidence rate ratio (AIRR)=1.16; 95% CI 1.04, 1.30), feeding in less than 72 hours (AIRR=1.17; 95% CI 1.05, 1.31), stage 3 hypoxic-ischaemic injury (AIRR=1.20; 95% CI 1.04, 1.39), length of hospital stay (AIRR=1.01; 95% CI 1.01, 1.03) and macrosomia (AIRR=1.39; 95% CI 1.19, 1.63) were significant factors associated with recurrence of hypoglycaemia.

The current study indicated that the mean recurrence of hypoglycaemia in newborns experiencing perinatal asphyxia was considerably higher. Presence of neonatal meningitis, delayed initiation of feeding 72 hours after birth, stage 3 hypoxic-ischaemic injury, length of hospital stay and macrosomia were the key factors associated with recurrence of hypoglycaemia.