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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
224
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
UZ Brussel
Brussels, Belgium
Children's Hospital Zagreb
Zagreb, Croatia
Hospital Jeanne de Flandre, Pediatrics Department, CHRU
Lille, France
CHU Tours
Tours, France
Agia Sofia Children's Hospital
Athens, Greece
Aristotle University of Thessaloniki, School of Medicine
Thessaloniki, 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, Iran
Mofid Children Hospital
Tehran, Iran
...and 9 more locations
BMI z-score
The change in BMI z-score over the intervention period of 3 months
Time frame: 3 months
Weight change
The change in WFH-weight for height (z-scores) over the intervention period of 3 months
Time frame: 3 months
Infectious complications
Frequency of infectious complications (number of days with temperature \>38,5°C, number of infections requiring antibiotic use)
Time frame: 3 months
Hospital admissions
Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
Time frame: 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
Time frame: 3 months
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