The aim of the Continuous versus Intermittent Nutrition in Pediatric Intensive Care randomized controlled trial (RCT) is to investigate a strategy of intermittent nutrition with a focus on an overnight feeding interruption period versus 24-hour…
ID
Source
Brief title
Condition
- Fatal outcomes
Synonym
Health condition
All health conditions requiring admittance to the intensive care unit
Research involving
Sponsors and support
Intervention
- Food (substances)
Outcome measures
Primary outcome
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 outcome
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).
Background summary
Intermittent fasting is a time-restricted feeding strategy with proven health benefits, which is based on multiple metabolic and endocrine changes, in several patient populations and healthy participants. In the pediatric intensive care unit (PICU), artificial feeding is usually administered 24 hours a day, although solid evidence supporting this practice is lacking. This discards the potential benefits of fasting in this population. We hypothesize that intermittent nutrition with a focus on an overnight feeding interruption (intermittent fasting), as compared with 24-hour continuous nutrition, is a feasible and safe strategy, with potential benefits, for critically ill children.
Study objective
The aim of the Continuous versus Intermittent Nutrition in Pediatric Intensive Care randomized controlled trial (RCT) is to investigate a strategy of intermittent nutrition with a focus on an overnight feeding interruption period versus 24-hour nutrition during the first 14 days in the PICU.
Study design
The Continuous versus Intermittent Nutrition in Pediatric Intensive Care study is an investigator-initiated RCT in a tertiary referral PICU. Critically ill children (term newborn to 18 years), expected to stay in the PICU for ≥48 hours, and dependent on artificial nutrition, are eligible for inclusion. This study will randomize critically ill children (n=140) to a continuous versus
intermittent nutrition strategy. In both groups, similar daily caloric targets will be prescribed. In the continuous group (control), nutrition will be administered 24 hours a day, with a maximum interruption period of 2 hours. In the intermittent group (intervention), nutrition will be interrupted during an age-dependent overnight fasting period. The study intervention will last until admission day 14, initiation of oral intake, or discharge from the PICU, whichever comes first. The primary outcome is the difference in ketosis between the groups under the condition of noninferiority regarding caloric intake. Secondary outcomes are feeding intolerance; the proportion of severe and resistant hypoglycemic events and severe gastrointestinal complications; and additional observed effects on nutritional intake, circadian rhythm, and clinically relevant outcome measures of the intermittent feeding strategy compared with continuous nutrition.
Intervention
Intermittent feeding with an overnight fast
Age
Inclusion criteria
Critically ill children (term newborn – 18 yrs), with expected stay >2 days, and dependent of artificial nutrition in PICU within 2 days.
Exclusion criteria
- Possibility to “oral” feeds, - “Do not resuscitate” code at the time of PICU admission, - Expected death within 24 hours, - Re-admission to the PICU after previous randomization to the ContInNuPIC trial, - Transfer from another ICU after a stay of more than three days, - Ketoacidotic/ hyperosmolar coma on admission, - Metabolic diseases requiring specific diet or with a contraindication to (intermittent) feeding, - Premature newborns (<37 weeks gestational age), - Short bowel syndrome or other conditions which required home-PN.
Design
Recruitment
IPD sharing statement
Plan description
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7877 |
| CCMO | NL70184.000.19 |
| OMON | NL-OMON48138 |