Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

Study Overview
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Brief Summary
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In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.

Official Title
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Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients

Conditions
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Critical Illness, Children

Intervention / Treatment
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* Other: Late parenteral nutrition


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission Exclusion Criteria: Age of 17 years or older Patients with a DNR code at the time of ICU admission. Patients expected to die within 12 hours (=moribund patients). Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge Patients transferred from another paediatric intensive care after a stay of more than 7 days Patients suffering from ketoacidotic or hyperosmolar coma on admission. Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN Patients suspicious or established inborn metabolic diseases requiring specific diet STRONGkids score lower than 2 on ICU admission. Premature Newborns ( 37 weeks gestational age upon admission in the PICU) Prior inclusion in another randomized controlled outcome study

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Early parenteral nutrition<br>Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center | |
| Experimental: Late parenteral nutrition<br>Parenteral nutrition will be withheld during the first 7 days of ICU stay | Other: Late parenteral nutrition<br>* Withholding parenteral nutrition during the first 7 days of ICU stay<br>* Other names: Late PN;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of new infection during ICU stay |  | during ICU stay and up to 90 days post-randomization | 
| Duration of ICU dependency (crude stay days and time to alive discharge from ICU) |  | during ICU stay and up to 90 days post-randomization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | during ICU stay, hospital stay and up to 90 days post-randomization | 
| Time to alive discharge from hospital |  | during hospital stay and up to 90 days post-randomization | 
| Incidence of hypoglycaemia during ICU stay |  | during the intervention window up to day 8 post-randomization | 
| Time to final weaning from mechanical respiratory support |  | during ICU stay and up to 90 days post-randomization | 
| Incidence of liver dysfunction during ICU stay |  | during ICU stay and up 90 days post-randomization | 
| Need for haemodynamic support during ICU stay |  | during ICU stay and up 90 days post-randomization | 
| Incidence of new kidney injury during ICU stay |  | during ICU stay and up 90 days post-randomization | 
| Duration of antibiotics treatment during ICU stay |  | during ICU stay and up to 90 days post-randomization | 
| Number of readmissions to the ICU |  | up to 90 days post-randomization | 
| Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance |  | during the intervention window of 8 days and up to 90 days post-randomization | 
| Markers of inflammation such as C-reactive protein concentrations during ICU stay |  | during ICU stay and up to 90 days post-randomization | 
| Structural and or functional differences in muscle tissue during ICU stay |  | during ICU stay and up to 90 days post-randomization | 
| biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples | with healthy matched control group | up to 4 years post-randomization | 
| functional and neurocognitive development | with healthy matched control group | up to 4 years post-randomization | 
| health economy analysis | total health care costs during hospital stay | during index hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical illness, children, nutrition, metabolism