Slow Introduction of Nutrition for Ill Malnourished Children
Reduced Calorie Feeds in the Early Management of Ill Severely Malnourished Children: a Phase I Clinical Trial
The Hospital for Sick Children
135 participants
Feb 5, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria6
- 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 Criteria20
- 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
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Interventions
Standard 'F75' (75 kcal/100 ml) 95 kcal/kg/day 12.05 mg/kg/min glucose
Reduced caloric 'F50' (50kcal/100ml) 63 kcal/kg/day 8.03mg/kg/min glucose
Reduced caloric 'F35' (35 kcal/100ml) * 47 kcal/kg/day * 5.62 mg/kg/min glucose
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06846749