Slow Introduction of Nutrition for Ill Malnourished Children

Launched by THE HOSPITAL FOR SICK CHILDREN · Feb 20, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how to safely feed severely malnourished children who are sick in the hospital. The main goal is to find out if giving them lower calorie feeds during the early stages of treatment can help them recover without causing low blood sugar. Researchers will compare two types of lower calorie feeds (F50 and F35) with the standard feed (F75) to see which is most effective and safe for the children.

To be eligible for this trial, children need to be between 6 months and 59 months old, admitted to the hospital with an illness, and showing signs of severe malnutrition. Participants will receive one of the feeds during their hospital stay and will be closely monitored for any health issues, especially low blood sugar. This monitoring helps ensure that they are stable and can transition to a diet that helps them gain weight as they recover. If you have a child who might qualify, you will need to provide written consent and be available to stay in the study area for the duration of the trial.

Gender

ALL

Eligibility criteria

• 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-drawing" or "nasal flaring" or "head-nodding"
• • Clinical/Lab Feature: Oxygenation Criteria: "Central cyanosis" or SaO2 \<90%
• • Clinical/Lab Feature: Circulation Criteria: Limb temperature gradient or capillary refill \>3 seconds
• • Clinical/Lab Feature: Reduced conscious level Criteria: AVPU \< "A"
• • Clinical/Lab Feature: Rapid pulse Criteria: Heartbeat per min \> 180
• • Clinical/Lab Feature: Severe anemia Criteria: Haemoglobin \< 7g/dl
• • Clinical/Lab Feature: Hypoglycemia Criteria: Blood glucose \< 3mmol/L
• • Clinical/Lab Feature: Abnormal temperature Criteria: Axial temperature \<36 or \>38oC
• • Clinical/Lab Feature: Very low MUAC Criteria: MUAC \<11cm