Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight

Not Applicable

Completed

• Conditions: Disease Associated Underweight

• 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

Study Timeline

• Study First Submitted: 2015-03-02
• Study First Submitted QC: 2015-03-04
• Study First Posted: 2015-03-09
• Study Start: 2015-12
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2018-11
• Last Update Submitted: 2018-11-05
• Last Update Posted: 2018-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 224

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

UZ Brussel; 🇧🇪 Brussel, 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, Islamic Republic of

Mofid Children Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of

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