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Not Applicable

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
Must not have
Patients suspicious or established inborn metabolic diseases requiring specific diet
Age of 17 years or older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 4 years post-randomization
Awards & highlights

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My child's STRONGkids score was 2 or more when admitted to the ICU.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have a genetic condition that requires a special diet.
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I am 17 years old or older.
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I was readmitted to the ICU more than 48 hours after my first discharge from the PEPaNIC trial.
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I have Short Bowel Syndrome and need home parenteral nutrition.
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My newborn was admitted to the PICU before reaching 37 weeks of pregnancy.
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I was in a severe diabetic coma when admitted to the hospital.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 4 years post-randomization
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 4 years post-randomization for reporting.

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 more

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
In critically ill patients, delaying parenteral nutrition (PN) during the first week can potentially improve outcomes by reducing complications such as infections and metabolic disturbances. The mechanism behind this approach is to allow the body to utilize its own energy reserves and reduce the risk of overfeeding, which can lead to hyperglycemia and increased infection rates. Additionally, early aggressive fluid resuscitation helps restore tissue perfusion, while timely administration of antibiotics targets the underlying infection, both of which are critical in stabilizing the patient. These treatments are essential as they address the immediate life-threatening aspects of critical illness, thereby improving survival and recovery.
Research Priorities for Pediatric Intensive Care Nutrition Within the United Kingdom: A National Institute of Health Research James Lind Alliance Priority Setting Partnership.The Use of Bowel Protocols in Critically Ill Adult Patients: A Systematic Review and Meta-Analysis.

Find a Location

Who is running the clinical trial?

KU LeuvenLead Sponsor
560 Previous Clinical Trials
200,339,514 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

Late parenteral nutrition (Not Applicable) Clinical Trial Eligibility Overview. Trial Name: NCT01536275 — N/A
Critical Illness Research Study Groups: Early parenteral nutrition, Late parenteral nutrition
Critical Illness Clinical Trial 2023: Late parenteral nutrition Highlights & Side Effects. Trial Name: NCT01536275 — N/A
Late parenteral nutrition (Not Applicable) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01536275 — N/A
~110 spots leftby Jul 2025