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| Name | Class |
|---|---|
| Children's Hospital Zagreb | OTHER |
| Universitair Ziekenhuis Brussel | OTHER |
| General Hospital Of Thessaloniki Ippokratio | OTHER |
| Medical University of Warsaw |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Nutritional Supplement (ONS) | Experimental | Diet consultation for the child/family + ONS |
|
| No Oran Nutritional Supplement (ONS) | No Intervention | Diet consultation for the child/family |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| BMI z-score | The change in BMI z-score over the intervention period of 3 months | 3 months |
| 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) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Michael Chourdakis, MD PhD | AUTH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZ Brussel | Brussels | Belgium | ||||
| Children's Hospital Zagreb |
| OTHER |
| Russian Medical Academy of Postgraduate Education | OTHER |
| Oxford University Hospitals NHS Trust | OTHER |
| Dokuz Eylul University | OTHER |
| Ludwig-Maximilians - University of Munich | OTHER |
| Aghia Sophia Children's Hospital of Athens | OTHER |
| Hacettepe University | OTHER |
| Children's Memorial Health Institute, Poland | OTHER |
| University Hospital, Lille | OTHER |
| Oslo University Hospital | OTHER |
| University Hospital, Tours | OTHER |
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|
| 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 |
| Zagreb |
| Croatia |
| Hospital Jeanne de Flandre, Pediatrics Department, CHRU | Lille | France |
| CHU Tours | Tours | 37000 | France |
| Agia Sofia Children's Hospital | Athens | Greece |
| Aristotle University of Thessaloniki, School of Medicine | Thessaloniki | 54124 | Greece |
| 1st Paediatric Dept, Hippokration Hospital, AUTH | Thessaloniki | Greece |
| 3rd Paediatric Dept, Hippokration Hospital, AUTH | Thessaloniki | Greece |
| Tehran University of Medical Sciences Tehrān, Children Medical Center | Tehran | 1419733151 | Iran |
| Mofid Children Hospital | Tehran | Iran |
| Department of Pediatrics, Women and Children's Division, Oslo University Hospital | Oslo | Norway |
| Medical University of Warsaw | Warsaw | 01-184 | Poland |
| The Children's Memorial Health Institute | Warsaw | 04-730 | Poland |
| Kazan State Medical University | Kazan' | Tatarstan Republic | 420012 | Russia |
| Russian Medical Academy of Postgraduate Education | Moscow | 125480 | Russia |
| Dokuz Eylul University, | Izmir | Inciralti-izmir | 35340 | Turkey (Türkiye) |
| Hacettepe University, Ankara | Ankara | 06100 | Turkey (Türkiye) |
| Ankara University School of Medicine | Ankara | Turkey (Türkiye) |
| Inönü University School of Medicine | İnönü | Turkey (Türkiye) |
| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D013851 | Thinness |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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