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Paediatric Resuscitation Outcome in Children with Heart Disease (ProCHD): protocol of a Germany-wide multicentre, prospective open registry

Por: Markel · F. · Kramer · P. · Anand · J. · Heimberg · E. · Herbsleb · V. · Amann · V. · Herberg · U. · von Borell du Vernay · F. · Seidemann · K. · Liem · L. · Michaelis · A. · Schmitt · K. · Weidenbach · M.
Introduction

While paediatric cardiac arrest is a rare event, consequences for the patients are significant with a considerable risk of morbidity, disability and mortality. The risk of cardiac arrest is substantially increased in children with congenital heart disease. Nevertheless, there is a lack of data concerning this population. To close this knowledge gap, this multicentre, prospective, open registry aims to implement a standardised structure for data collection and follow-up of paediatric cardiac arrests associated with heart diseases in Germany.

Methods and analysis

All paediatric patients who experience a cardiac arrest and receive at least 2 minutes of cardiopulmonary resuscitation are invited to participate in this registry. The dataset comprises demographical, clinical, resuscitation and outcome data, collected in accordance with the Utstein guidelines. Neurological assessments, cognitive and motor tests are conducted at fixed intervals. Additionally, patient-reported outcome measures will be surveyed. Primary outcomes are survival to discharge and neurodevelopmental outcome after discharge and 2 years. The data are pseudonymised prior to submission to an online REDCap database, which is centrally hosted on a server located in Leipzig, Germany.

Ethics and dissemination

This study follows the Declaration of Helsinki and received ethical approval from the Ethics Committee in Leipzig. Registry results will allow us to understand the epidemiology, guideline adherence, risk factors and will be presented at conferences and submitted to a peer-reviewed journal for publication.

Trial registration number

NCT05373498.

Safety and potential efficacy of DM199, a tissue kallikrein-1 analogue, for treating pre-eclampsia and fetal growth restriction: study protocol for a South African, hospital-based phase I/II open-label trial

Por: Cluver · C. A. · Thake · J. · Hassim · T. · van Greunen · A. · Budhram · S. · Knipe · K. · Decloedt · E. · Brink · L. · Langenegger · E. · Bergman · L. · Imberg · H. · Bekker · A. · Walker · S. P. · Tong · S.
Introduction

Pre-eclampsia and fetal growth restriction are leading causes of perinatal morbidity and mortality. A therapy that enhances maternal vascular function and promotes vasodilation to increase placental perfusion could treat both conditions.

Tissue kallikrein-1 is an endogenous enzyme that releases bradykinin to activate the bradykinin 2 receptor on endothelial cells. This induces potent vasodilation and pro-angiogenic, anti-oxidant and anti-inflammatory effects.

DM199 is a recombinant form of tissue kallikrein which can be administered intravenously or subcutaneously. Clinical trials in non-pregnant populations have demonstrated its safety. Being a protein, it is unlikely to cross the placenta. This protocol describes an early-phase trial for DM199 for pre-eclampsia and fetal growth restriction.

Methods and analysis

This phase IB/IIA open-label trial at Tygerberg Hospital, Western Cape Province, South Africa, will determine the safety and effective dose of DM199 for pre-eclampsia and/or fetal growth restriction. The trial consists of two parts. Part 1 will be an ascending dose finding study, treating women with pre-eclampsia and severe hypertension who are for planned birth within 72 hours. This will search for doses that safely lower blood pressure (n=3/dose, recruiting up to 42 participants). Part 2 is a safety and efficacy study of three cohorts of pregnant women (n=30/cohort): (1) with pre-eclampsia and severe hypertension requiring delivery within 72 hours, (2) with preterm pre-eclampsia (

Ethics and dissemination

The trial has ethical approval (Health Research Ethics Committee, Stellenbosch University, Protocol number M24/04/009) and is registered (Pan African Clinical Trial Registry, PACTR202404895013782) and approved by the South African Health Products Regulatory Authority (20240801). Data will be presented at international conferences and published in peer-reviewed journals.

Diet and diet-related challenges with specific focus on carbohydrates and carbohydrate counting in adults with type 1 diabetes: a cross-sectional study

Por: Sterner Isaksson · S. · Hellman · J. · Wijkman · M. · Imberg · H. · Olafsdottir · A. F. · Axelsen · M. · Lind · M.
Objectives

To explore dietary intake, diet-related challenges in glucose management and perceived needs for dietary support among Swedish adults with type 1 diabetes (T1D).

Design

Cross-sectional observational study based on an electronic survey that included the validated Meal-Q food frequency questionnaire and additional questions on dietary habits and management. Participant characteristics were retrieved from the Swedish National Diabetes Register. Descriptive and correlation analyses were conducted.

Setting

Three diabetes specialist clinics in Sweden.

Participants

375 adults with T1D.

Main outcome measures

Dietary intake and diet-related challenges in glucose management.

Results

A total of 191 persons (mean age 48 years; 48% female) consented to participate. The mean (SD) glycated haemoglobin A1c was 56 (13) mmol/mol, mean glucose 8.8 (2.2) mmol/L, time in range (TIR) 64% (18%) and BMI 27 (4.3) kg/m²; 41% used insulin pumps. Mean carbohydrate intake was 183 g/day (41% of energy, E%). Fibre intake was 23 g/day (3.1 g/MJ), and saturated fat intake was 29 g/day (15 E%), both inconsistent with dietary recommendations. About half (51%) found carbohydrate counting challenging, with 53% estimating carbohydrate intake visually and only 18% using advanced methods. Additionally, 48% reported reducing carbohydrate intake, and 61% avoided certain carbohydrate-rich foods due to glucose management difficulties. Approximately 40% of participants reported insufficient dietary guidance from their healthcare providers since diagnosis, 33% expressed interest in further dietitian support and 39% believed dietary changes could improve glucose control.

Conclusions

Participants reported lower fibre intake and higher saturated fat intake compared with dietary guidelines. Many found carbohydrate counting and carbohydrate-rich meals challenging. One-third expressed a wish for additional dietary support. These findings highlight the importance of improving access to tailored dietary counselling in routine T1D care.

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