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Continuous versus Intermittent Nutrition in Paediatric Intensive Care: proof-of-concept

Continuous versus Intermittent Nutrition in Paediatric Intensive Care: proof-of-concept

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON22860
Enrollment
140
Registered
2019-07-16
Start date
2020-05-19
Completion date
Unknown
Last updated
2025-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

All health conditions requiring admittance to the intensive care unit critical care

Interventions

intermitterend voeden met een nachtelijke vastenperiode

Sponsors

European Society for Clinical Nutrition and Metabolism
Lead Sponsor
Sophia Research Foundation
Collaborator

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

Inclusion criteria: 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)

Exclusion criteria

Exclusion criteria: - 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

Design outcomes

Primary

MeasureTime frame
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.

Secondary

MeasureTime frame
Secondary parameters of the proof-of-concept study will be validating a fasting response in “Intermittent’ as compared to “Continuous” feeding by means of endocrine and metabolic (glycaemic control, ketone production, lactate, autophagy) measurements, and the evaluation of the circadian rhythm (cortisol/ACTH, sleep quality, chrono-pharmacokinetics and vital sign variability).

Contacts

Public ContactSascha Verbruggen

Erasmus MC

s.verbruggen@erasmusmc.nl+31 10 703 2770

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)