Clinical trial NCT02383329: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Official title: Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Disease Associated Underweight
Keywords: malnutrition
Underweight
Oral Nutrition Supplements
Children
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
Collaborators: name: Children's Hospital Zagreb
name: Universitair Ziekenhuis Brussel
name: General Hospital Of Thessaloniki Ippokratio
name: Medical University of Warsaw
name: Russian Medical Academy of Postgraduate Education
name: Oxford University Hospitals NHS Trust
name: Dokuz Eylul University
name: Ludwig-Maximilians - University of Munich
name: Aghia Sophia Children's Hospital of Athens
name: Hacettepe University
name: Children's Memorial Health Institute, Poland
name: University Hospital, Lille
name: Oslo University Hospital
name: University Hospital, Tours
First posted: 2015-03-09
Enrollment: 224
Sex: ALL
Minimum age (years): 24
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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


Eligibility criteria: 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

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Primary outcomes:
measure: BMI z-score
timeFrame: 3 months
Secondary outcomes:
measure: Weight change
timeFrame: 3 months
measure: Infectious complications
timeFrame: 3 months
measure: Hospital admissions
timeFrame: 3 months
measure: Gastrointestinal complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: UZ Brussel
city: Zagreb
country: Croatia
facility: Children's Hospital Zagreb
city: Lille
country: France
facility: Hospital Jeanne de Flandre, Pediatrics Department, CHRU
city: Tours
country: France
facility: CHU Tours
city: Athens
country: Greece
facility: Agia Sofia Children's Hospital
city: Thessaloniki
country: Greece
facility: Aristotle University of Thessaloniki, School of Medicine
city: Thessaloniki
country: Greece
facility: 1st Paediatric Dept, Hippokration Hospital, AUTH
city: Thessaloniki
country: Greece
facility: 3rd Paediatric Dept, Hippokration Hospital, AUTH
city: Tehran
country: Iran, Islamic Republic of
facility: Tehran University of Medical Sciences Tehrān, Children Medical Center
city: Tehran
country: Iran, Islamic Republic of
facility: Mofid Children Hospital
city: Oslo
country: Norway
facility: Department of Pediatrics, Women and Children's Division, Oslo University Hospital
city: Warszawa
country: Poland
facility: Medical University of Warsaw
city: Warszawa
country: Poland
facility: The Children's Memorial Health Institute
city: Kazan
country: Russian Federation
facility: Kazan State Medical University
state: Respublika Tatarstan
city: Moscow
country: Russian Federation
facility: Russian Medical Academy of Postgraduate Education
city: Izmir
country: Turkey
facility: Dokuz Eylul University,
state: Inciralti-izmir
city: Ankara
country: Turkey
facility: Hacettepe University, Ankara
city: Ankara
country: Turkey
facility: Ankara University School of Medicine
city: Inönü
country: Turkey
facility: Inönü University School of Medicine
Study officials:
affiliation: AUTH
name: Michael Chourdakis, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: