Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit (PEPaNIC)

February 9, 2024 updated by: Greet Van den Berghe, KU Leuven

Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients

In the PEPaNIC trial it is investigated whether withholding parenteral nutrition during the first week in critically ill children is beneficial, compared to the current standard of the early start of parenteral nutrition.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1440

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Leuven, Belgium, 3000
        • Dept Intensive Care Medicine
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital
  • Netherlands
      • Rotterdam, Netherlands, 3015
        • Erasmus MC Sophia Kinderziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • All patients admitted to the PICU with a STRONGkids score of 2 points or more upon ICU admission

Exclusion Criteria:

  • Age of 17 years or older
  • Patients with a DNR code at the time of ICU admission.
  • Patients expected to die within 12 hours (=moribund patients).
  • Patient readmitted to ICU after randomization to the PEPaNIC trial, more than 48 hours after the initial discharge
  • Patients transferred from another paediatric intensive care after a stay of more than 7 days
  • Patients suffering from ketoacidotic or hyperosmolar coma on admission.
  • Patients suffering from Short Bowel Syndrome on home PN or other conditions that require home PN
  • Patients suspicious or established inborn metabolic diseases requiring specific diet
  • STRONGkids score lower than 2 on ICU admission.
  • Premature Newborns ( 37 weeks gestational age upon admission in the PICU)
  • Prior inclusion in another randomized controlled outcome study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Early parenteral nutrition
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
Experimental: Late parenteral nutrition
Parenteral nutrition will be withheld during the first 7 days of ICU stay
Other: Late parenteral nutrition
Withholding parenteral nutrition during the first 7 days of ICU stay
Other Names:
  • Late PN

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of new infection during ICU stay
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization
Duration of ICU dependency (crude stay days and time to alive discharge from ICU)
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality
Time Frame: during ICU stay, hospital stay and up to 90 days post-randomization
during ICU stay, hospital stay and up to 90 days post-randomization
Time to alive discharge from hospital
Time Frame: during hospital stay and up to 90 days post-randomization
during hospital stay and up to 90 days post-randomization
Incidence of hypoglycaemia during ICU stay
Time Frame: during the intervention window up to day 8 post-randomization
during the intervention window up to day 8 post-randomization
Time to final weaning from mechanical respiratory support
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization
Incidence of liver dysfunction during ICU stay
Time Frame: during ICU stay and up 90 days post-randomization
during ICU stay and up 90 days post-randomization
Need for haemodynamic support during ICU stay
Time Frame: during ICU stay and up 90 days post-randomization
during ICU stay and up 90 days post-randomization
Incidence of new kidney injury during ICU stay
Time Frame: during ICU stay and up 90 days post-randomization
during ICU stay and up 90 days post-randomization
Duration of antibiotics treatment during ICU stay
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization
Number of readmissions to the ICU
Time Frame: up to 90 days post-randomization
up to 90 days post-randomization
Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance
Time Frame: during the intervention window of 8 days and up to 90 days post-randomization
during the intervention window of 8 days and up to 90 days post-randomization
Markers of inflammation such as C-reactive protein concentrations during ICU stay
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization
Structural and or functional differences in muscle tissue during ICU stay
Time Frame: during ICU stay and up to 90 days post-randomization
during ICU stay and up to 90 days post-randomization
biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples
Time Frame: up to 4 years post-randomization
with healthy matched control group
up to 4 years post-randomization
functional and neurocognitive development
Time Frame: up to 4 years post-randomization
with healthy matched control group
up to 4 years post-randomization
health economy analysis
Time Frame: during index hospitalization
total health care costs during hospital stay
during index hospitalization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

KU Leuven

Collaborators

Stollery Children's Hospital
Sophia Kindergeneeskunde

Investigators

  • Principal Investigator: Greet Van den Berghe, MD PhD, KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

March 1, 2016

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

February 16, 2012

First Submitted That Met QC Criteria

February 21, 2012

First Posted (Estimated)

February 22, 2012

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEPaNIC
  • 2012-000811-10 (EudraCT Number)
  • ML8052 (Other Identifier: IRB KU Leuven)
  • NL38772.000.12 (Other Identifier: IRB CCMO Netherlands)
  • IWT-TBM 110685 (Other Grant/Funding Number: Agency for Innovation by Science & Technology)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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