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

Completed

Conditions: Algemene kritieke zieke populatie. Groot scala aan aandoeningen en ziektebeelden mogelijk
Critically ill children
10016950

Registration Number: NL-OMON55180

Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

Inclusion Criteria

All critically ill children admitted to the PICU are evaluated for nutritional
risk and eligibility for inclusion in this study. All critically ill children,
(term born * 18 yrs), with expected stay at least two days, and dependent of
artificial nutrition in PICU within 2 days are eligible for inclusion.

Exclusion Criteria

Exclusion criteria are possibility to *oral* feeds, a *do not resuscitate* code
at the time of PICU admission, expected death within 24 hours, re-admission to
the PICU >48 hours after previous inclusion to the ContInNuPIC trial, transfer
from another ICU after a stay of three days or more or having received
artificial nutrition, ketoacidotic/ hyperosmolar coma on admission, metabolic
diseases requiring specific diet or with a contraindication to (intermittent)
feeding, and premature newborns (<37 weeks gestational age), short bowel
syndrome or other conditions which require PN before admission, and
participation in another RCT in the PICU that might influence the clinical
outcome .

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome of the proof-of-concept study will be the feasibility<br /><br>(nutritional intake, enteral tolerance) and safety (glycaemic control,<br /><br>gastro-intestinal complications) of a daily feeding and fasting cycle in<br /><br>critically ill children of different age-groups while providing equal amounts<br /><br>of daily nutrients as with standard continuous feeding. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary parameters of the proof-of-concept study will be validating a fasting<br /><br>response in Intermittent' as compared to Continuous feeding by means of<br /><br>endocrine (IGF-I, T3/rT3, insulin, glucagon) and metabolic (glycaemic control,<br /><br>ketone production, lactate, bilirubin, urea, free fatty acids, autophagy)<br /><br>measurements, and the evaluation of the circadian rhythm (cortisol, melatonin,<br /><br>sleep quality, chrono-pharmacokinetics and vital sign variability).</p><br>