Clinical trial NCT01536275: Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit
Official title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Critical Illness
Children
Keywords: critical illness
children
nutrition
metabolism
Lead sponsor: KU Leuven
Sponsor class: OTHER
Collaborators: name: Sophia Kindergeneeskunde
name: Stollery Children's Hospital
First posted: 2012-02-22
Enrollment: 1440
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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)
* Prior inclusion in another randomized controlled outcome study

Primary outcomes:
measure: Incidence of new infection during ICU stay
timeFrame: during ICU stay and up to 90 days post-randomization
measure: Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
timeFrame: during ICU stay and up to 90 days post-randomization
Secondary outcomes:
measure: Mortality
timeFrame: during ICU stay, hospital stay and up to 90 days post-randomization
measure: Time to alive discharge from hospital
timeFrame: during hospital stay and up to 90 days post-randomization
measure: Incidence of hypoglycaemia during ICU stay
timeFrame: during the intervention window up to day 8 post-randomization
measure: Time to final weaning from mechanical respiratory support
timeFrame: during ICU stay and up to 90 days post-randomization
measure: Incidence of liver dysfunction during ICU stay
timeFrame: during ICU stay and up 90 days post-randomization
measure: Need for haemodynamic support during ICU stay
timeFrame: during ICU stay and up 90 days post-randomization
measure: Incidence of new kidney injury during ICU stay
timeFrame: during ICU stay and up 90 days post-randomization
measure: Duration of antibiotics treatment during ICU stay
timeFrame: during ICU stay and up to 90 days post-randomization
measure: Number of readmissions to the ICU
timeFrame: up to 90 days post-randomization
measure: Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
timeFrame: during the intervention window of 8 days and up to 90 days post-randomization
measure: Markers of inflammation such as C-reactive protein concentrations during ICU stay
timeFrame: during ICU stay and up to 90 days post-randomization
measure: Structural and or functional differences in muscle tissue during ICU stay
timeFrame: during ICU stay and up to 90 days post-randomization
measure: biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples
timeFrame: up to 4 years post-randomization
measure: functional and neurocognitive development
timeFrame: up to 4 years post-randomization
measure: health economy analysis
timeFrame: during index hospitalization
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Dept Intensive Care Medicine
city: Edmonton
country: Canada
facility: Stollery Children's Hospital
state: Alberta
city: Rotterdam
country: Netherlands
facility: Erasmus MC Sophia Kinderziekenhuis
Study officials:
affiliation: KU Leuven
name: Greet Van den Berghe, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26.
citation: Coppens G, Vanhorebeek I, Verlinden I, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Guiza F, Van den Berghe G. Assessment of aberrant DNA methylation two years after paediatric critical illness: a pre-planned secondary analysis of the international PEPaNIC trial. Epigenetics. 2023 Dec;18(1):2146966. doi: 10.1080/15592294.2022.2146966. Epub 2022 Nov 16.
citation: Vanhorebeek I, Jacobs A, Mebis L, Dulfer K, Eveleens R, Van Cleemput H, Wouters PJ, Verlinden I, Joosten K, Verbruggen S, Van den Berghe G. Impact of critical illness and withholding of early parenteral nutrition in the pediatric intensive care unit on long-term physical performance of children: a 4-year follow-up of the PEPaNIC randomized controlled trial. Crit Care. 2022 May 12;26(1):133. doi: 10.1186/s13054-022-04010-3.
citation: Verlinden I, Guiza F, Dulfer K, Van Cleemput H, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Physical, Emotional/Behavioral, and Neurocognitive Developmental Outcomes From 2 to 4 Years After PICU Admission: A Secondary Analysis of the Early Versus Late Parenteral Nutrition Randomized Controlled Trial Cohort. Pediatr Crit Care Med. 2022 Aug 1;23(8):580-592. doi: 10.1097/PCC.0000000000002971. Epub 2022 May 9.
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