Disease Associated Underweight
Conditions
Keywords
malnutrition, Underweight, Oral Nutrition Supplements, Children
Brief summary
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
Interventions
DIETARY_SUPPLEMENTThe ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
Sponsors
Children's Hospital Zagreb
Universitair Ziekenhuis Brussel
General Hospital Of Thessaloniki Ippokratio
Medical University of Warsaw
Russian Medical Academy of Postgraduate Education
Oxford University Hospitals NHS Trust
Dokuz Eylul University
Ludwig-Maximilians - University of Munich
Aghia Sophia Children's Hospital of Athens
Hacettepe University
Children's Memorial Health Institute, Poland
University Hospital, Lille
Oslo University Hospital
University Hospital, Tours
Dr. Michael Chourdakis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Months to 12 Years
Healthy volunteers
No
Inclusion criteria
1. Children treated at the participating paediatric centres during the study period (inpatients or outpatients) 2. Age between 24 months to 12 years at inclusion 3. 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 4. Children who would be considered candidates for oral nutrition intervention (but do not need tube feeding) 5. Written informed consent of parents/caregivers
Exclusion criteria
1. Children in need of intensive care 2. Inability to consume ONS (e.g. major gastrointestinal dysfunction) 3. Children, for whom normal nutrition intervention would be inappropriate (e.g. food intolerance, allergy) 4. Use of parenteral feeding and/or enteral tube-feeding 5. Severe edema (\>0.5 cm pitting edema on the dorsum of the foot) 6. Participation in another intervention study involving investigational or marketed products concomitantly or within two weeks prior to entry into the trial. 7. Children having received enteral nutrition treatment for underweight in the previous month 8. Oncology patients during chemo-, radio-therapy 9. Expected hospital stay at inclusion longer than 7 days \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BMI z-score | 3 months | The change in BMI z-score over the intervention period of 3 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Weight change | 3 months | The change in WFH-weight for height (z-scores) over the intervention period of 3 months |
| Infectious complications | 3 months | Frequency of infectious complications (number of days with temperature \>38,5°C, number of infections requiring antibiotic use) |
| Hospital admissions | 3 months | Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions) |
| Gastrointestinal complications | 3 months | 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 |
Countries
Belgium, Croatia, France, Greece, Iran, Norway, Poland, Russia, Turkey (Türkiye)
Outcome results
None listed