Late Parenteral Nutrition for Critical Illness in Children

(PEPaNIC Trial)

Recruiting at 2 trial locations

Overseen By Tom Fivez, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: KU Leuven

Disqualifiers: Age 17+, DNR code, Moribund, Short Bowel Syndrome, Metabolic diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

1440 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is late parenteral nutrition safe for children?

Research shows that delaying parenteral nutrition for one week in critically ill children can reduce infections and speed up recovery, although it may cause a higher rise in bilirubin (a substance made by the liver). Overall, it appears to be safe and may have benefits over starting nutrition early. ^{1 2 3 4 5}

How does late parenteral nutrition differ from other treatments for critically ill children?

Late parenteral nutrition involves delaying the start of supplemental nutrition through an IV for one week in critically ill children, which has been shown to reduce infections and speed up recovery compared to starting it early. This approach is unique because it allows the body to use its own resources initially, potentially improving long-term neurocognitive development without negatively affecting growth or health. ^{1 2 3 4 6}

What data supports the effectiveness of the treatment Late parenteral nutrition for critical illness in children?

Research shows that delaying parenteral nutrition (nutrition given through a vein) for one week in critically ill children can reduce infections and speed up recovery compared to starting it early. Additionally, this approach did not negatively impact long-term growth or health and even improved brain development. ^{1 2 3 4 6}

Who Is on the Research Team?

Greet Van den Berghe, MD PhD

Principal Investigator

KU Leuven

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My child's STRONGkids score was 2 or more when admitted to the ICU.

Exclusion 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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either early or late parenteral nutrition during their ICU stay

1 week

Follow-up

Participants are monitored for functional and neurocognitive development, and other health outcomes

up to 4 years

What Are the Treatments Tested in This Trial?

Interventions

• Late parenteral nutrition

Trial Overview 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.

How Is the Trial Designed?

Group I: Late parenteral nutrition Experimental Treatment 1 Intervention

Parenteral nutrition will be withheld during the first 7 days of ICU stay

Group II: Early parenteral nutrition Active Control 1 Intervention

Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center

Who Is Running the Clinical Trial?

KU Leuven

Lead Sponsor

Trials

587

Recruited

200,340,000+

Sophia Kindergeneeskunde

Collaborator

Trials

2

Recruited

1,500+

Stollery Children's Hospital

Collaborator

Trials

25

Recruited

25,900+

Citations

1. England pubmed.ncbi.nlm.nih.gov

Timing of the initiation of parenteral nutrition in critically ill children. [2022]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Early Supplemental Parenteral Nutrition in Critically Ill Children: An Update. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Long-term developmental effects of withholding parenteral nutrition for 1 week in the paediatric intensive care unit: a 2-year follow-up of the PEPaNIC international, randomised, controlled trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Prevalence and Prognostic Value of Abnormal Liver Test Results in Critically Ill Children and the Impact of Delaying Parenteral Nutrition. [2020]

5. England pubmed.ncbi.nlm.nih.gov

Early versus late parenteral nutrition for critically ill term and late preterm infants. [2022]

6. Spain pubmed.ncbi.nlm.nih.gov

Influencing the timing of parenteral nutrition initiation in the pediatric intensive care unit. [2022]