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Late Parenteral Nutrition for Critical Illness in Children (PEPaNIC Trial)
N/A
Waitlist Available
Led By Greet Van den Berghe, MD PhD
Research Sponsored by KU Leuven
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years post-randomization
Awards & highlights
PEPaNIC Trial Summary
This trial is investigating whether it is beneficial to withhold parenteral nutrition from critically ill children during the first week, compared to the current standard of starting parenteral nutrition early.
Who is the study for?
This trial is for critically ill children admitted to the PICU with a moderate risk of malnutrition (STRONGkids score ≥2). It excludes those with specific dietary needs due to metabolic diseases, a stay in another PICU >7 days, expected death within 12 hours, age ≥17 years, DNR orders at admission, readmission after initial discharge from this trial (>48 hours), certain comas on admission, Short Bowel Syndrome or home PN requirement, and premature newborns.Check my eligibility
What is being tested?
The PEPaNIC trial examines if delaying parenteral nutrition (PN) for one week benefits critically ill children compared to starting PN early. The study aims to determine which approach leads to better outcomes during their ICU stay.See study design
What are the potential side effects?
While the information provided does not specify side effects directly related to late versus early parenteral nutrition interventions being tested in this clinical trial, generally speaking PN can sometimes lead to infections at catheter sites or imbalances in blood sugar levels.
PEPaNIC Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My child's STRONGkids score was 2 or more when admitted to the ICU.
PEPaNIC Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 4 years post-randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years post-randomization
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
Incidence of new infection during ICU stay
Secondary outcome measures
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Duration of antibiotics treatment during ICU stay
Incidence of hypoglycaemia during ICU stay
+12 morePEPaNIC Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Late parenteral nutritionExperimental Treatment1 Intervention
Parenteral nutrition will be withheld during the first 7 days of ICU stay
Group II: Early parenteral nutritionActive Control1 Intervention
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
Find a Location
Who is running the clinical trial?
KU LeuvenLead Sponsor
549 Previous Clinical Trials
200,337,454 Total Patients Enrolled
13 Trials studying Critical Illness
18,225 Patients Enrolled for Critical Illness
Sophia KindergeneeskundeOTHER
1 Previous Clinical Trials
78 Total Patients Enrolled
Stollery Children's HospitalOTHER
23 Previous Clinical Trials
24,302 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition that requires a special diet.I am 17 years old or older.I was readmitted to the ICU more than 48 hours after my first discharge from the PEPaNIC trial.I have Short Bowel Syndrome and need home parenteral nutrition.My newborn was admitted to the PICU before reaching 37 weeks of pregnancy.My child's STRONGkids score was 2 or more when admitted to the ICU.I was in a severe diabetic coma when admitted to the hospital.
Research Study Groups:
This trial has the following groups:- Group 1: Early parenteral nutrition
- Group 2: Late parenteral nutrition
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any opportunities to participate in this research endeavor?
"Clinicaltrials.gov reveals that this experiment is in its recruitment phase, with the first post dated June 1st 2012 and last amendment made on March 8th 2022."
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