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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON55180
Enrollment
140
Registered
2020-02-11
Start date
2020-05-11
Completion date
Unknown
Last updated
2024-04-15

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

Conditions

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

Interventions

The *Continuous Nutrition* strategy will be the nutritional management currently recommended and acting as *control*. Both enteral nutrition (EN) and (after day 7) parenteral nutrition (PN) will be
EN will be started as early as possible (

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
No minimum to 17 Years

Inclusion criteria

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: 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 (

Design outcomes

Primary

MeasureTime frame
The primary outcome of the proof-of-concept study will be the feasibility (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 (IGF-I, T3/rT3, insulin, glucagon) and metabolic (glycaemic control, ketone production, lactate, bilirubin, urea, free fatty acids, autophagy) measurements, and the evaluation of the circadian rhythm (cortisol, melatonin, sleep quality, chrono-pharmacokinetics and vital sign variability).

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)