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Found 2 Actively Recruiting clinical trials
Actively Recruiting
The ICU-related Out-of-Pocket Expenses ICOPE study is a multinational, prospective observational study conducted in African and Asian countries to understand the financial impact of ICU care on patients and their families. The study focuses on measuring out-of-pocket expenses and the occurrence of catastrophic health expenditure among patients who stay in the ICU for more than 24 hours, including those who receive mechanical ventilation and those who do not. The study addresses the rising cost burden related to ICU care in low- and middle-income countries LMICs and aims to identify factors contributing to financial hardship. Participants include all patients admitted to participating ICUs during a 14-day recruitment period, with a planned sample size of at least 354 patients. The study compares groups of patients receiving invasive mechanical ventilation with those who do not, tracking their ICU-related expenses. The follow-up period extends from ICU admission to discharge, with additional assessments at 30 days and 6 months, spanning a total study duration of 18 months. During the study, researchers will collect detailed information about direct and indirect costs associated with ICU care, including medical and non-medical expenses. They will also examine how families cope with these costs and identify risk factors for catastrophic health expenditure. The primary outcomes include out-of-pocket cost per patient episode and the relative risk of catastrophic health expenditure by ICU discharge. Secondary outcomes include risk factors for catastrophic expenditure and the frequency of various coping strategies used by families.
Actively Recruiting
Healthy Volunteer
Researchers are studying how nutritional supplements made from milk proteins, lactoferrin and lysozyme, may help children aged 6 to 24 months who were hospitalized for diarrhea and have malnutrition. These children are at high risk of repeated diarrhea and poor nutritional recovery despite receiving usual treatments like oral rehydration solutions. The study is a phase 3, double-blind, placebo-controlled randomized trial taking place at seven hospitals in Western Kenya, enrolling 600 participants. Participants will be randomly assigned to receive one of four treatments daily for 16 weeks lactoferrin, lysozyme, a combination of both, or a placebo made of rice powder. Caregivers will mix the assigned supplement with porridge or other complementary foods. After treatment, children will be followed for a total of 24 weeks with clinic visits at weeks 4, 10, 16, and 24, along with bi-weekly home visits by community health workers. During the study, researchers will collect health history information and samples including stool, blood, and possibly urine. They will monitor diarrhea episodes, nutritional recovery, hospitalizations, growth measurements, and markers of intestinal health. Caregivers will report adherence and acceptability of the supplements. The study aims to assess whether these supplements reduce diarrhea recurrence and improve nutrition over six months, while also evaluating safety and cost-effectiveness.