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NCT Number: NCT01536275

Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Critical Illness Children Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dept Intensive Care Medicine, Leuven, Belgium

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Late parenteral nutrition

Other

Withholding parenteral nutrition during the first 7 days of ICU stay

Other names: Late PN

Primary outcomes

  1. Incidence of new infection during ICU stay

    Time frame: during ICU stay and up to 90 days post-randomization

  2. 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

Secondary outcomes

  1. Mortality

    Time frame: during ICU stay, hospital stay and up to 90 days post-randomization

  2. Time to alive discharge from hospital

    Time frame: during hospital stay and up to 90 days post-randomization

  3. Incidence of hypoglycaemia during ICU stay

    Time frame: during the intervention window up to day 8 post-randomization

  4. Time to final weaning from mechanical respiratory support

    Time frame: during ICU stay and up to 90 days post-randomization

  5. Incidence of liver dysfunction during ICU stay

    Time frame: during ICU stay and up 90 days post-randomization

  6. Need for haemodynamic support during ICU stay

    Time frame: during ICU stay and up 90 days post-randomization

  7. Incidence of new kidney injury during ICU stay

    Time frame: during ICU stay and up 90 days post-randomization

  8. Duration of antibiotics treatment during ICU stay

    Time frame: during ICU stay and up to 90 days post-randomization

  9. Number of readmissions to the ICU

    Time frame: up to 90 days post-randomization

  10. 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

  11. Markers of inflammation such as C-reactive protein concentrations during ICU stay

    Time frame: during ICU stay and up to 90 days post-randomization

  12. Structural and or functional differences in muscle tissue during ICU stay

    Time frame: during ICU stay and up to 90 days post-randomization

  13. 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

  14. functional and neurocognitive development

    Time frame: up to 4 years post-randomization

    with healthy matched control group

  15. health economy analysis

    Time frame: during index hospitalization

    total health care costs during hospital stay

Sponsors and collaborators

Lead sponsor

KU Leuven

Other

Collaborators

  • Sophia Kindergeneeskunde
  • Stollery Children's Hospital

Registry information

Official study title

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

Acronym: PEPaNIC

Important dates

Study start
2012
Primary completion
2016
Study completion
2026
First posted
Feb 22, 2012
Registry last updated
Feb 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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