The goal of this clinical trial is to learn if giving lower calorie feeds during the first stage of treatment helps improve survival in severely malnourished children who are ill. The main question it aims to answer is:
Is it safe to feed ill severely malnourished children lower calorie feeds during the early treatment phase?
Researchers will compare two lower calorie feeds (F50 and F35) to the standard feed (F75) to see if they help children recover safely without increasing their risk of low blood sugar (hypoglycemia).
Participants will:
* Receive one of the lower calorie feeds (F50 or F35) or the standard feed (F75) during their hospital stay.
* Be closely monitored for low blood sugar and signs for worsening of clinical symptoms.
* Be treated until they are stable and ready to be fed more calories to help them gain weight.
Who can participate
Age range
6 Months – 59 Months
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age - greater than or equal to 6 months to less than 59 months (age range for which WHO guidelines were developed and where children are not expected to be exclusively breastfeeding
* Admitted to hospital with acute, non-traumatic illness and having received a maximum of 2 feeds of F75 at time of enrolment
* Severe malnutrition (WHZ \<-3 z-scores of the median WHO growth standards and/or MUAC \<115mm)
* Accompanied by care provider able to provide written or witnessed informed consent
* Primary caregiver plans to stay in the study area for the duration of the study
* Having no more than one clinical sign displayed below "Clinical/Lab Feature \& Criteria"
Exclusion Criteria:
* Has oedematous malnutrition (excluded for this safety focused trial as fluid accumulation influences weight which is used to calculate required caloric intake)
* Requires immediate cardiac/respiratory resuscitation (chest compressions/ventilation)
* Clinical contraindications for enteral nutrition
* Admission for traumatic or surgical indication
* Weighs \<3.5kg
* Presence of terminal illness likely to result in death within 6 months
* Known congenital heart disease
* Have had 2 documented hypoglycaemic events in hospital
* More than one clinical sign displayed below "Clinical/Lab Feature \& Criteria"
* Primary caregiver declines to provide informed consent
Clinical/Lab Feature \& Criteria Guidelines
Clinical/Lab Feature: Respiratory distress Oxygenation Criteria: "Subcostal in…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Episodes of moderate hypoglycemia
Timeframe: During the period of F75/F50/F35 provision meaning the stabilization phase which is on average 3 days