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Found 3 Actively Recruiting clinical trials
Actively Recruiting
This research aims to improve care for children recovering from severe acute malnutrition (SAM) and moderate acute malnutrition (MAM) by testing new simplified approaches to follow-up after recovery. The goal is to enhance program coverage and effectiveness by comparing different monitoring strategies for identifying relapse to acute malnutrition. This study follows children aged 6 to 59 months who have recovered from SAM or MAM treatment in related clinical trials. Participants will receive training in family mid-upper arm circumference (MUAC) measurement, enabling primary caregivers to screen at home. This is compared to scheduled anthropometric screenings conducted by health care workers at 1, 3, and 6 months after recovery. Additionally, nutrition, infant and young child feeding (IYCF), and water, sanitation, and hygiene (WASH) education are provided as part of the study interventions. During the study, children will be monitored for relapse episodes over a 6-month period using these different follow-up methods. Researchers will track the number of relapse episodes to acute malnutrition and evaluate the effectiveness and safety of family-led MUAC screening compared to health facility-led follow-up and standard community-based visits. The study focuses on practical ways to support caregivers and improve early detection of malnutrition relapse.
Actively Recruiting
Researchers are investigating new simplified treatment approaches for children aged 6 to 59 months suffering from moderate acute malnutrition (MAM). This trial aims to improve program coverage by testing two new fixed-dose regimens of ready-to-use therapeutic food (RUTF) against the current fixed-dose regimen of ready-to-use supplementary food (RUSF). The study addresses challenges in current community-based management of acute malnutrition protocols, which have remained largely unchanged for over 20 years and have had limited reach due to complexity and supply issues. Participants will be assigned to receive either the standard RUSF or one of two fixed-dose RUTF regimens. Both RUSF and RUTF are dietary supplements formulated to UNICEF specifications. The study evaluates the safety, efficacy, and cost-effectiveness of these modified doses for treating MAM in young children. The treatment period and detailed dosing schedules are part of the clinical trial design but are not specified in the summary. During the study, children will be closely monitored for nutritional recovery over a period of up to 16 weeks. Researchers will assess short-term nutritional improvement as the primary outcome. Participants must reside in the local health post area and be available for follow-up. Assessments will include appetite tests, measurements of mid-upper arm circumference, weight-for-height Z-scores, and evaluations for any medical complications. Safety and effectiveness will be tracked throughout the treatment period to determine the best approach for managing MAM in this population.
Actively Recruiting
Researchers are evaluating new simplified treatment methods for children aged 6 to 59 months with severe acute malnutrition (SAM) in Ethiopia. This study tests two fixed-dose regimens of ready-to-use therapeutic food (RUTF) against the current weight-based dosing method. The goal is to improve program coverage and simplify treatment protocols that have not changed much in over 20 years, addressing challenges that leave many children without care. The study involves giving children standard RUTF that meets UNICEF specifications along with Amoxicillin following Ethiopian national guidelines. Children will be randomized to receive either fixed doses or the weight-based dose of RUTF. The treatment focuses on uncomplicated SAM cases without severe illnesses requiring hospitalization. The study will assess short-term nutritional recovery over a period of up to 16 weeks. Participants will be closely monitored through the treatment period to evaluate recovery from malnutrition. Researchers will track nutritional status using measurements like mid-upper arm circumference and weight-for-height Z-scores. Safety and adherence to treatment will be observed, and caregivers will provide consent before enrollment. The total participation time includes the treatment and follow-up to determine the effectiveness and safety of the modified RUTF dosing.