Clinical Research Directory

Treatment of Severe Acute Malnutrition in Children 6 to 59 Months Old With Standard Ready To Use Therapeutic Food Compared to a Newly Formulated Lipid Optimized Ready To Use Therapeutic Food

The goal of this randomized clinical trial is to learn if a newly formulated Lipid-Optimized Ready-to-Use Therapeutic Food (LO-RUTF) can treat severe acute malnutrition in children aged 6 to 59 months. The main questions it aims to answer are: 1. Does LO-RUTF impact physical recovery from severe acute malnutrition in participants? 2. Does LO-RUTF impact neurocognitive performance after 8 and 12 weeks of treatment? Researchers will compare LO-RUTF to standard RUTF see if our energy-dense food compares to standard issue RUTF in terms of promoting recovery from severe acute malnutrition. Participants will * Take a one-week ration of LO-RUTF or standard RUTF based on the participant's weight * Return every week for checkups, tests and to receive the next ration of assigned RUTF if eligible * Be assessed for neurocognitive function through Malawi Developmental Assessment Tool (MDAT) at three time points (before treatment, 4 weeks, 12 weeks)

Opportunistic Pneumococcal Immunisation Trial in MALnutrition

The goal of the OPTIMAL clinical trial is to learn if a dose of a pneumococcal conjugate vaccine (PCV) generates a good immune response in young children who are in hospital with severe acute malnutrition. Researchers will compare an intervention group who get a dose of a PCV (Pneumosil) to a control group who get a dose of a Typhoid conjugate vaccine (Typbar TCV). To ensure all participants receive timely potential benefits, at 3 months participants in the intervention group with receive a dose of Typbar TCV, and those in the conrol group will receive a dose of Pneumosil. Participants will be visited 4 times at their homes over six months after vaccination, with a phone review at 12 months after vaccination.

Comparison of Low Osmolar ORS and ReSoMal for Treating Acute Watery Diarrhea in Severely Malnourished Children Aged 6 Months to 5 Years

Acute watery diarrhea is a common and serious health issue in children, especially in those who are severely malnourished. These children are at a much higher risk of complications such as dehydration, electrolyte imbalances, and even death. Oral Rehydration Solutions (ORS) are a widely used treatment to prevent and correct dehydration in such children. However, there are different types of ORS, and it is still unclear which one is more effective and safer for use in severely malnourished children. This clinical study is being conducted at The Children's Hospital, Lahore, to compare two different types of ORS: low osmolar ORS and ReSoMal (a special rehydration solution designed for malnourished children). The aim is to determine which solution is more effective in correcting low potassium levels (a common problem in these children) and to identify which one has fewer side effects, particularly problems like low or high sodium levels that can be dangerous. A total of 72 children between 6 months and 5 years of age, all diagnosed with severe malnutrition and mild to moderate dehydration due to acute watery diarrhea, will be included in the study. They will be randomly assigned to receive either low osmolar ORS or ReSoMal. Blood tests will be done before and after the treatment to check for changes in electrolyte levels. The frequency of diarrhea and the child's overall response to treatment will also be recorded. The hypothesis of this study is that there is a significant difference in both effectiveness and side effects between the two ORS solutions. The results of this study will help doctors choose the safest and most effective ORS for treating diarrhea in severely malnourished children, improving care and potentially saving lives.

Severe Acute Malnutrition and Child Development Clinical Trial in Mwanza

This is a randomized clinical trial to learn whether ready-to-use therapeutic foods enriched with choline and docosahexaenoic acid (DHA) together with psychosocial stimulating activities work well to improve child development in children with severe acute malnutrition(SAM). The overall question this trial aims to answer is can the health and development outcomes of children with SAM be improved through optimized nutritional treatment and integrated psychosocial support. Researchers will compare the new ready-to-use therapeutic food and an integrated psychosocial stimulation to a standard look-alike nutritional supplement that contains no additional nutrients being investigated and the standard nutritional counseling given locally and assess its effects on child development in children with severe acute malnutrition. Participants will: * Be given the trial interventions which will be delivered over 12 weeks * After the 12 weeks of intervention, participants will return for outcome evaluations (week 12 study visit), which will be repeated at follow-up visits after 24 and 48 weeks.