Late Parenteral Nutrition for Critical Illness in Children

(PEPaNIC Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether starting parenteral nutrition (feeding through a vein) later, rather than immediately, benefits critically ill children in the ICU. The trial compares two approaches: the standard method of starting nutrition immediately and an experimental approach of delaying it for the first week. Children admitted to the pediatric ICU with a STRONGkids score (a nutrition risk screening tool) of 2 or more may be suitable candidates for this trial. As an unphased study, this trial provides a unique opportunity to contribute to important research that could enhance care for future pediatric ICU patients.

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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that delaying parenteral nutrition (giving nutrients directly into the bloodstream) for the first week in very sick children can be beneficial. Studies have found that this delay is linked to a shorter stay in the pediatric ICU, reducing it by about 2.7 days on average. Importantly, waiting to start this nutrition proved more effective than starting it early in undernourished, critically ill children. This indicates that the treatment is well-tolerated and can be safely delayed without harming the children. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores a new approach to providing nutrition for critically ill children in the ICU. Unlike the standard practice of administering parenteral nutrition early, this trial investigates the potential benefits of delaying parenteral nutrition until after the first seven days of an ICU stay. By withholding nutrition initially, the trial may reveal insights into how the timing of nutrition can impact recovery and outcomes, potentially leading to improved practices in pediatric critical care.

What evidence suggests that late parenteral nutrition might be an effective treatment for critically ill children?

Research has shown that waiting one week before starting IV feeding, as practiced in the "Late parenteral nutrition" arm of this trial, can improve health outcomes in very sick children. Studies have found that this delay can reduce their stay in the pediatric ICU by about 2.7 days. It can also lower infection risk and speed up recovery. However, this approach might not suit all children, particularly those who are undernourished. Overall, evidence suggests that delaying IV feeding could enhance recovery in certain serious conditions. ^{1 3 4 5 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. nejm.org nejm.org/doi/full/10.1056/NEJMoa1514762

Early versus Late Parenteral Nutrition in Critically Ill Children Late parenteral nutrition was also associated with a shorter stay in the pediatric ICU by a mean of 2.7 days (95% CI, 1.3 to 4.3) (Table 2), ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT01536275

NCT01536275 | Early Versus Late Parenteral Nutrition in ... In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4999758/

Time of parenteral nutrition in paediatric critical care patients ... It is well known that a delay in nutrient administration in the critical patient leads to a poor prognosis (1-4). It can induce an increase in nosocomial ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2702217

Outcomes of Delaying Parenteral Nutrition for 1 Week vs ... The undernourished children benefited from withholding PN during the first week of critical illness as compared with initiating PN at the first ...

5. withpower.com withpower.com/trial/phase-critical-illness-5-2012-0bd76

Late Parenteral Nutrition for Critical Illness in Children · Info ... Research shows that delaying parenteral nutrition for one week in critically ill children can reduce infections and speed up recovery, although it may cause ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30646158/

Outcomes of Delaying Parenteral Nutrition for 1 Week vs ... In undernourished critically ill children, withholding PN for 1 week was clinically superior to early PN.