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

Withdrawn

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

• Registration Number: NL-OMON48138
• Lead Sponsor: Erasmus MC, Universitair Medisch Centrum Rotterdam

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 90

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
and/or expected death within 24 hours at the time of PICU admission,
re-admission to the PICU after previous randomization to the ContInNuPIC trial,
transfer from another ICU after a stay of more than three days, ketoacidosis or
hyperosmolar coma on admission or inborn metabolic diseases requiring specific
diet, premature new-borns (<37 weeks gestational age), short bowel syndrome or
other conditions which required home-PN.

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) and metabolic (glycaemic control, ketone production,<br /><br>lactate, bilirubin, urea, autophagy) measurements, and the evaluation of the<br /><br>circadian rhythm (cortisol/ACTH, sleep quality, chrono-pharmacokinetics and<br /><br>vital sign variability).</p><br>