Intermittent versus continuous enteral feeding is feasible and safe in critically ill children, and intermittent feeding will lead to a fasting response with an increased ketosis, which could potentially activate autophagy while providing sufficient…
ID
Bron
Verkorte titel
Aandoening
- Fatale aflopen
Aandoening
All health conditions requiring admittance to the intensive care unit
Betreft onderzoek met
Ondersteuning
Onderzoeksproduct en/of interventie
- Voedingsstoffen/Voedingsmiddelen
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome of the proof-of-concept study will be the feasibility (ketogeneic response, nutritional intake, enteral tolerance) and safety (glycaemic control, gastro-intestinal complications) of a daily feeding and fasting cycle in critically ill children of different age-groups while providing equal amounts of daily nutrients as with standard continuous feeding.
Achtergrond van het onderzoek
Rationale: Withholding Parenteral Nutrition during the first week of critical illness, as compared with an early start (<48 hours), reduced length of intensive care dependency and the number of nosocomial infections. The benefit of this counterintuitive nutritional strategy, through which low macronutrient intakes were accepted, is presumed to be caused by activation of autophagy due to a fasting response with increased ketosis. Autophagy is an intracellular recycling process crucial for maintaining cellular integrity and function. Its protective role against various forms of critical illness induced organ failure, including ICU acquired muscle weakness, is strongly activated during periods of fasting. Currently, artificial feeding is usually administered through continuous infusion, although solid evidence supporting this practice is lacking. Intermittent, as compared with continuous, (par)enteral nutrition may provide a more physiological feeding/fasting pattern which activates autophagy, while providing sufficient nutrition during critical illness. Such a physiological feeding/fasting pattern could also sustain circadian rhythm and influence pharmacodynamics and kinetics in critically ill children. Objective: The main research objectives for the proof-of-concept study are to show the feasibility and safety of a daily cycle of feeding and fasting in critically ill children of different age-groups, that will trigger an adequate fasting response while providing equal amounts of daily nutrients as with standard continuous (24hrs) feeding. Study design: A randomized non-blinded proof-of-concept study to explore the feasibility and safety of intermittent feeding in 140 critically ill children stratified over three age groups; neonates (≤28d), infants (<1yr) and children (≥1yr) while overall providing sufficient amounts of daily nutrients as with standard continuous feeding. The study intervention will last a maximum of 14 days or until PICU discharge, or the ability for “oral nutrition”, whichever comes first.
Doel van het onderzoek
Intermittent versus continuous enteral feeding is feasible and safe in critically ill children, and intermittent feeding will lead to a fasting response with an increased ketosis, which could potentially activate autophagy while providing sufficient nutrition.
Onderzoeksopzet
PICU admission
Onderzoeksproduct en/of interventie
intermitterend voeden met een nachtelijke vastenperiode
Algemeen / deelnemers
Wetenschappers
Leeftijd
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Kritiek zieke kinderen (aterm geboren - 18 jaar oud), met verwachte opnameduur van 2 dagen of meer, verwacht afhankelijk te worden/zijn van kunstmatige voeding (sondevoeding of voeding via het infuus)
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- mogelijkheid tot orale intake
- niet reanimeren beleid
- verwacht overlijden binnen 24u
- heropname na eerdere deelname
- transfer vanaf andere kinder IC meer dan 3 dagen of daar al voeding gehad
- ketoacidose/hyperosmolair coma
- metabole aandoening waarvoor speciaal dieet gevolgd wordt of contra-indicatie voor (intermitterend) voeden
- premature leeftijd (<37 weken postmenstruale leeftijd)
- short bowel syndroom of andere aandoening waardoor reeds infuusvoeding nodig is
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Toelichting
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
Register | ID |
---|---|
NTR-new | NL7877 |
CCMO | NL70184.000.19 |
OMON | NL-OMON48138 |