Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
- Conditions
- Disease Associated Underweight
- Interventions
- 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
- Registration Number
- NCT02383329
- Lead Sponsor
- Dr. Michael Chourdakis
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 224
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Oral Nutritional Supplement (ONS) The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml Diet consultation for the child/family + ONS
- Primary Outcome Measures
Name Time Method BMI z-score 3 months The change in BMI z-score over the intervention period of 3 months
- Secondary Outcome Measures
Name Time Method 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
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)
Trial Locations
- Locations (19)
Hospital Jeanne de Flandre, Pediatrics Department, CHRU
🇫🇷Lille, France
CHU Tours
🇫🇷Tours, France
Aristotle University of Thessaloniki, School of Medicine
🇬🇷Thessaloniki, Greece
3rd Paediatric Dept, Hippokration Hospital, AUTH
🇬🇷Thessaloniki, Greece
Mofid Children Hospital
🇮🇷Tehran, Iran, Islamic Republic of
Department of Pediatrics, Women and Children's Division, Oslo University Hospital
🇳🇴Oslo, Norway
Kazan State Medical University
🇷🇺Kazan, Respublika Tatarstan, Russian Federation
Ankara University School of Medicine
🇹🇷Ankara, Turkey
Russian Medical Academy of Postgraduate Education
🇷🇺Moscow, Russian Federation
Dokuz Eylul University,
🇹🇷Izmir, Inciralti-izmir, Turkey
Inönü University School of Medicine
🇹🇷Inönü, Turkey
Children's Hospital Zagreb
🇭🇷Zagreb, Croatia
Hacettepe University, Ankara
🇹🇷Ankara, Turkey
1st Paediatric Dept, Hippokration Hospital, AUTH
🇬🇷Thessaloniki, Greece
Agia Sofia Children's Hospital
🇬🇷Athens, Greece
Tehran University of Medical Sciences Tehrān, Children Medical Center
🇮🇷Tehran, Iran, Islamic Republic of
UZ Brussel
🇧🇪Brussel, Belgium
Medical University of Warsaw
🇵🇱Warszawa, Poland
The Children's Memorial Health Institute
🇵🇱Warszawa, Poland