Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

Study Overview
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Brief Summary
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The purpose of this study is to test whether the provision of ONS to malnourished children across Europe, in addition to standard counselling, will improve weight gain and other outcomes. The hypothesis to be tested is: • Supplementation with ONS in malnourished paediatric patients will lead to increased WFH gain, as well as less malnutrition related complications (e.g. infections). Primary outcome • The change in BMI z-score over the intervention period of 3 months Secondary outcomes • The change in WFH-weight for height (z-scores) over the intervention period of 3 months

Official Title
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Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

Conditions
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Disease Associated Underweight

Intervention / Treatment
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* Dietary Supplement: The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children treated at the participating paediatric centres during the study period (inpatients or outpatients) Age between 24 months to 12 years at inclusion WFH at inclusion <- 1,5 SD - >-2,5 SD (based on WHO) OR Decrease in WFH z-score of ≥1 SD within the last 3 months, and underlying disease with high risk of undernutrition Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding) Written informed consent of parents/caregivers Exclusion Criteria: Children in need of intensive care Inability to consume ONS (e.g. major gastrointestinal dysfunction) Children, for whom normal nutrition intervention would be inappropriate (e.g. food intolerance, allergy) Use of parenteral feeding and/or enteral tube-feeding Severe edema (>0.5 cm pitting edema on the dorsum of the foot) Participation in another intervention study involving investigational or marketed products concomitantly or within two weeks prior to entry into the trial. Children having received enteral nutrition treatment for underweight in the previous month Oncology patients during chemo-, radio-therapy Expected hospital stay at inclusion longer than 7 days -

Ages Eligible for Study
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Minimum Age: 24 Months
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Nutritional Supplement (ONS)<br>Diet consultation for the child/family + ONS | Dietary Supplement: The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml<br>* The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml<br>|
| No Intervention: No Oran Nutritional Supplement (ONS)<br>Diet consultation for the child/family | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BMI z-score | The change in BMI z-score over the intervention period of 3 months | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight change | The change in WFH-weight for height (z-scores) over the intervention period of 3 months | 3 months | 
| Infectious complications | Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use) | 3 months | 
| Hospital admissions | Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions) | 3 months | 
| Gastrointestinal complications | Frequency of gastrointestinal complications (number of days with diarrhoea/vomiting as reported by carers). Other GI symptoms could be recorded, as potential reason for lower food intake | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malnutrition, Underweight, Oral Nutrition Supplements, Children