An interventional study of The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml in Disease Associated Underweight, sponsored by Dr. Michael Chourdakis. Completed at 19 sites in 9 countries. Open to participants aged 24 Months to 12 Years. Per ClinicalTrials.gov, last updated 2018-11-06.
Sponsored by Dr. Michael Chourdakis · Not applicable, Interventional, and Supportive care
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:
Primary outcome • The change in BMI z-score over the intervention period of 3 months
Secondary outcomes
1,277 studies on the registry are indexed under Malnutrition; 230 are open to participants now.
This study's enrollment of 224 is above the median of 118 across 843 interventional studies indexed under Malnutrition.
Browse Malnutrition studies →This is the only study on the registry with Dr. Michael Chourdakis as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Expected hospital stay at inclusion longer than 7 days
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diet consultation for the child/family + ONS
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
Diet consultation for the child/family
The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
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
Ran from Dec 2015 to primary completion in May 2018, 29 months.
Of 392 non-industry interventional studies with no phase under Malnutrition, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 37. This study's 29 months is above that.
Counting every sponsor, half of 418 studies reached it within 22 months; a quarter within 11 and three quarters within 37.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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