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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
1,440
Withholding parenteral nutrition during the first 7 days of ICU stay
Dept Intensive Care Medicine
Leuven, Belgium
Stollery Children's Hospital
Edmonton, Alberta, Canada
Erasmus MC Sophia Kinderziekenhuis
Rotterdam, Netherlands
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
Mortality
Time frame: during ICU stay, hospital stay and up to 90 days post-randomization
Time to alive discharge from hospital
Time frame: during hospital stay and up to 90 days post-randomization
Incidence of hypoglycaemia during ICU stay
Time frame: during the intervention window up to day 8 post-randomization
Time to final weaning from mechanical respiratory support
Time frame: during ICU stay and up to 90 days post-randomization
Incidence of liver dysfunction during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Need for haemodynamic support during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Incidence of new kidney injury during ICU stay
Time frame: during ICU stay and up 90 days post-randomization
Duration of antibiotics treatment during ICU stay
Time frame: during ICU stay and up to 90 days post-randomization
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Number of readmissions to the ICU
Time frame: up to 90 days post-randomization
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Time frame: 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
Time frame: during ICU stay and up to 90 days post-randomization
Structural and or functional differences in muscle tissue during ICU stay
Time frame: 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
Time frame: up to 4 years post-randomization
functional and neurocognitive development
with healthy matched control group
Time frame: up to 4 years post-randomization
health economy analysis
total health care costs during hospital stay
Time frame: during index hospitalization