Modified Dosage for Severe Acute Malnutrition

Launched by ACTION AGAINST HUNGER USA · Sep 24, 2023

Keywords

ClinConnect Summary

This clinical trial is looking at new ways to treat children with severe acute malnutrition, a serious condition where children do not get enough nutrients. For over 20 years, the methods used to help these children haven't changed much, which has left many without the care they need. The trial aims to test two simpler treatment approaches to see if they can help more children get the support they require. Specifically, researchers will compare two fixed amounts of a special food called Ready-to-Use Therapeutic Food (RUTF) with the current method that adjusts the amount based on a child's weight.

To participate in this trial, children must be between 6 months and 5 years old and have severe acute malnutrition that is uncomplicated, meaning they are not facing other serious health issues. Parents or caregivers will need to agree to let their child join the study. Eligible children will be evaluated at a local health center, where they will undergo a simple appetite test and have their arm circumference checked. If enrolled, families can expect regular follow-ups to monitor the child's progress. This trial is important because it aims to find more effective ways to help malnourished children recover and thrive.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 6-59 months
• • 2. Reside in the catchment area of the health post where the trial is to be conducted without plans to leave the area over the next year
• • 3. Uncomplicated severe acute malnutrition, as defined by no signs of severe illness that would require referral to inpatient facility
• • 4. Pass appetite test conducted at the time of enrollment
• • 5. Consent for randomization into the study given by mother, father, and/or other primary caregiver
• • 6. Mid-upper arm circumference less than 115 mm and/or nutritional edema
• • 7. Weight-for-height Z-score (WHZ) less than -3
• Exclusion Criteria:
• • 1. Complicated acute malnutrition with severe illness requiring transfer to a stabilization center or hospital for treatment. This includes, but is not limited to: a. Hypothermia b. High fever c. Signs of hypoglycemia d. Lethargy or altered mental status e. Moderate to severe dehydration f. Shock g. Other medical complications requiring hospitalization or higher-level medical evaluation
• • 2. Treatment for acute malnutrition, either as an inpatient or outpatient, within the past 3 months
• • 3. Known chronic medical illness such as severe cerebral palsy, severe congenital anomalies such as unrepaired congenital heart disease, Down syndrome, hydrocephalus, unrepaired cleft lip or palate, or other conditions that would be expected to contribute to difficulty feeding the prescribed amounts of therapeutic or supplementary food