What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Parenteral nutrition, commonly used in critically ill patients who cannot receive enteral nutrition, can lead to side effects such as infections from central venous catheters, metabolic disturbances like hyperglycemia and electrolyte imbalances, and liver dysfunction. Delaying parenteral nutrition, as investigated in the PEPaNIC trial, may reduce these complications by prioritizing enteral feeding, which is associated with fewer infections and better metabolic outcomes.

What prior FDA approvals exist?

The FDA has approved various treatments for critical illness, including parenteral nutrition for patients who cannot receive enteral nutrition. However, recent studies, such as the PEPaNIC trial, suggest that withholding parenteral nutrition during the first week of critical illness may reduce complications like infections and metabolic disturbances. This approach aligns with a broader trend in critical care to optimize nutritional support timing to improve patient outcomes. While specific FDA approvals for delaying parenteral nutrition are not detailed, the focus remains on balancing nutritional needs with minimizing potential adverse effects.

What other types of research exist?

Promising alternatives to withholding parenteral nutrition in critically ill patients include early enteral nutrition and immunonutrition. Early enteral nutrition, initiated within 24 hours of ICU admission, has been shown to reduce septic complications and improve overall outcomes. Immunonutrition, which involves supplementation with specific nutrients like arginine, omega-3 fatty acids, and nucleotides, has demonstrated benefits in reducing infection rates and enhancing immune function. Both strategies focus on providing adequate nutrition while minimizing the risks associated with parenteral nutrition.

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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

No Placebo-Only Group

Summary

This trial is testing if delaying IV nutrition helps very sick children recover better compared to starting IV nutrition right away.

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.

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.

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 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

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

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples

functional and neurocognitive development

health economy analysis

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 7Eligibility criteria met

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.