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

KU Leuven3 sites in 3 countries1,440 target enrollmentJune 2012

ConditionsCritical Illness Children

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Critical Illness
Sponsor: KU Leuven
Enrollment: 1440
Locations: 3
Primary Endpoint: Incidence of new infection during ICU stay
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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.

Registry

clinicaltrials.gov

Start Date

June 2012

End Date

December 2026

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

KU Leuven

Responsible Party

Principal Investigator

Greet Van den Berghe

Head of Dept Intensive Care Medicine

KU Leuven

Eligibility Criteria

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)

Outcomes

Primary Outcomes

Incidence of new infection during ICU stay

Time Frame: during ICU stay and up to 90 days post-randomization

Duration of ICU dependency (crude stay days and time to alive discharge from ICU)

Time Frame: during ICU stay and up to 90 days post-randomization

Secondary Outcomes

Mortality(during ICU stay, 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)
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)
Number of readmissions to the ICU(up to 90 days post-randomization)
health economy analysis(during index hospitalization)
Time to alive discharge from hospital(during hospital stay and up to 90 days post-randomization)
Time to final weaning from mechanical respiratory support(during ICU stay and up to 90 days post-randomization)
Duration of antibiotics treatment during ICU stay(during ICU stay and 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)
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(up to 4 years post-randomization)
functional and neurocognitive development(up to 4 years post-randomization)
Markers of inflammation such as C-reactive protein concentrations during ICU stay(during ICU stay and up to 90 days post-randomization)