Kisii

Researchers are conducting a multinational, prospective observational study called the ICU-related Out-of-Pocket Expenses (ICOPE) study in African and Asian countries. This study aims to measure the financial burden on patients and families related to ICU care, focusing on out-of-pocket expenses and catastrophic health expenditure. The study includes both ventilated and non-ventilated patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. Participants are followed during their ICU stay, which averages about 7 days, and additional follow-ups occur at 30 days and 6 months after admission. The study compares costs between patients receiving invasive mechanical ventilation and those who are not ventilated. It also investigates risk factors for catastrophic health expenditure and documents how families cope with the financial demands of ICU care. Throughout the study, researchers collect data on patient expenses, including direct medical and non-medical costs, as well as indirect costs such as income loss. The main outcomes measured are the out-of-pocket cost per patient episode until ICU discharge and the relative risk of catastrophic health expenditure. The total study duration spans 18 months, allowing for comprehensive assessment of financial impact and coping strategies over time.

Researchers are evaluating whether nutritional supplements made from milk proteins lactoferrin and lysozyme, alone or combined, can reduce repeated diarrhea episodes and improve nutritional recovery in children aged 6 to 24 months hospitalized with diarrhea and malnutrition in Western Kenya. This Phase 3 randomized, double-blind, placebo-controlled trial aims to address the high risk of illness and death faced by these children despite current diarrhea treatments like oral rehydration solution. The study will enroll 600 children with moderate or severe wasting (MUAC <12.5 cm) to test if these supplements can improve gut health and prevent new disease during a 6-month follow-up period. Participants will be randomly assigned to receive either lactoferrin, lysozyme, a combination of both, or a placebo for 16 weeks. Caregivers will be instructed to mix the supplements daily with their child's porridge or other complementary foods. The study includes bi-weekly home visits by community health workers and clinic visits at 4, 10, 16, and 24 weeks. This design allows monitoring of the supplements' effects and adherence over 6 months. Throughout the study, information on the child's health history will be collected along with stool, blood, and possibly urine samples to evaluate enteric infections, enteric function, and hemoglobin levels. The main outcomes measured are the incidence of moderate-to-severe diarrhea and the time to nutritional recovery over 6 months. Safety and acceptability will be assessed, and caregivers' adherence to the supplements will be monitored. The results aim to inform new strategies to reduce mortality and complications in malnourished children recovering from diarrhea.