Children, Critical Illness
Conditions
Keywords
critical illness, children, nutrition, metabolism
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.
Interventions
Withholding parenteral nutrition during the first 7 days of ICU stay
Sponsors
Sophia Kindergeneeskunde
Stollery Children's Hospital
KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Mortality | during ICU stay, hospital 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 | — |
| 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 | up to 4 years post-randomization | with healthy matched control group |
| functional and neurocognitive development | up to 4 years post-randomization | with healthy matched control group |
| health economy analysis | during index hospitalization | total health care costs during hospital stay |
| Number of readmissions to the ICU | up to 90 days post-randomization | — |
| Time to alive discharge from hospital | during hospital stay and up to 90 days post-randomization | — |
Countries
Belgium, Canada, Netherlands
Outcome results
None listed