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

Not Applicable

Completed

Conditions: <p>All health conditions requiring admittance to the intensive care unit</p>
critical care
10053172

Registration Number: NL-OMON22860

Lead Sponsor: European Society for Clinical Nutrition and Metabolism

Brief Summary: Between May 19, 2020, and July 13, 2022, 140 critically ill children, median (first quartile; third quartile) age 0.3 ( 0.1; 2.7) years, were randomised to intermittent (n=67) or continuous feeding (n=73). In the intermittent feeding group, BHB levels were significantly higher (median 0.4 (0.2; 1.0) vs. 0.3 (0.1; 0.7) mmol/L, p<0.001). The ratio of total caloric intake in the intermittent feeding group to the intake in the continuous feeding group was not consistently significantly more than 0.67, thus not proving non-inferiority. No severe, resistant hypoglycaemic events, nor severe gastrointestinal complications related to the intervention occurred, and feeding intolerance did not occur more often in the intermittent than in the continuous feeding group.

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 140

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

- mogelijkheid tot orale intake

- niet reanimeren beleid

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 (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.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>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).</p><br>