Effects of Oral Nutrition Supplements in Children With Disease Associated Underweight (MIntS)
5. november 2018 opdateret af: Dr. Michael Chourdakis
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
Studieoversigt
Status
Afsluttet
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
224
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Brussel, Belgien
- UZ Brussel
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Moscow, Den Russiske Føderation, 125480
- Russian Medical Academy of Postgraduate Education
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Respublika Tatarstan
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Kazan, Respublika Tatarstan, Den Russiske Føderation, 420012
- Kazan State Medical University
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Lille, Frankrig
- Hospital Jeanne de Flandre, Pediatrics Department, CHRU
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Tours, Frankrig, 37000
- CHU Tours
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Athens, Grækenland
- Agia Sofia Children's Hospital
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Thessaloniki, Grækenland, 54124
- Aristotle University Of Thessaloniki, School of Medicine
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Thessaloniki, Grækenland
- 1st Paediatric Dept, Hippokration Hospital, AUTH
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Thessaloniki, Grækenland
- 3rd Paediatric Dept, Hippokration Hospital, AUTH
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Tehran, Iran, Islamisk Republik, 1419733151
- Tehran University of Medical Sciences Tehrān, Children Medical Center
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Tehran, Iran, Islamisk Republik
- Mofid Children Hospital
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Ankara, Kalkun
- Ankara University School of Medicine
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Ankara, Kalkun, 06100
- Hacettepe University, Ankara
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Inönü, Kalkun
- Inönü University School of Medicine
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Inciralti-izmir
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Izmir, Inciralti-izmir, Kalkun, 35340
- Dokuz Eylul University,
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Zagreb, Kroatien
- Children's Hospital Zagreb
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Oslo, Norge
- Department of Pediatrics, Women and Children's Division, Oslo University Hospital
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Warszawa, Polen, 01-184
- Medical University of Warsaw
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Warszawa, Polen, 04-730
- The Children's Memorial Health Institute
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
2 år til 12 år (Barn)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
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Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Oral Nutritional Supplement (ONS)
Diet consultation for the child/family + ONS
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The ONS provided to the children intervention group will be a ready to drink age adapted oral nutrition supplement providing 1,5 kcal/ml
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Ingen indgriben: No Oran Nutritional Supplement (ONS)
Diet consultation for the child/family
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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BMI z-score
Tidsramme: 3 months
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The change in BMI z-score over the intervention period of 3 months
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3 months
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Weight change
Tidsramme: 3 months
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The change in WFH-weight for height (z-scores) over the intervention period of 3 months
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3 months
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Infectious complications
Tidsramme: 3 months
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Frequency of infectious complications (number of days with temperature >38,5°C, number of infections requiring antibiotic use)
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3 months
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Hospital admissions
Tidsramme: 3 months
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Admission for hospital inpatient treatments (number of days of hospital stay, number of admissions)
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3 months
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Gastrointestinal complications
Tidsramme: 3 months
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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
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3 months
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Michael Chourdakis, MD PhD, AUTH
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. december 2015
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Faktiske)
1. maj 2018
Datoer for studieregistrering
Først indsendt
2. marts 2015
Først indsendt, der opfyldte QC-kriterier
4. marts 2015
Først opslået (Skøn)
9. marts 2015
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. november 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. november 2018
Sidst verificeret
1. november 2018
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- AUTh112Med
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .