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

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ClinicalTrials.gov Identifier: NCT01536275
Recruitment Status : Recruiting
First Posted : February 22, 2012
Last Update Posted : June 22, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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.

Condition or disease Intervention/treatment
Critical Illness Children Other: Late parenteral nutrition

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of Early Parenteral Nutrition Completing Enteral Nutrition in Paediatric Critically Ill Patients
Study Start Date : June 2012
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

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 Name: Late PN


Outcome Measures

Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria

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Ages Eligible for Study:   up to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01536275


Contacts
Contact: Tom Fivez, MD 003216340989 tom.fivez@uzleuven.be
Contact: Dieter Mesotten, MD PhD 003216340977 dieter.mesotten@med.kuleuven.be

Locations
Belgium
Dept Intensive Care Medicine Recruiting
Leuven, Belgium, 3000
Contact: Tom Fivez, MD    003216340989    tom.fivez@uzleuven.be   
Contact: Dieter Mesotten, MD PhD    003216340977    dieter.mesotten@med.kuleuven.be   
Principal Investigator: Dieter Mesotten, MD PhD         
Sub-Investigator: Tom Fivez, MD         
Canada, Alberta
Stollery Children's Hospital Active, not recruiting
Edmonton, Alberta, Canada, T6G 2B7
Netherlands
Erasmus MC Sophia Kinderziekenhuis Recruiting
Rotterdam, Netherlands, 3015
Contact: Sascha Verbruggen, MD, PhD    0031107036669    s.verbruggen@erasmusmc.nl   
Contact: Koen Joosten, MD, PhD    0031107040704    k.joosten@erasmusmc.nl   
Sponsors and Collaborators
Katholieke Universiteit Leuven
Sophia Kindergeneeskunde
Stollery Children's Hospital
Investigators
Principal Investigator: Greet Van den Berghe, MD PhD KU Leuven
More Information

Additional Information:
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Greet Van den Berghe, Head of Dept Intensive Care Medicine, Katholieke Universiteit Leuven
ClinicalTrials.gov Identifier: NCT01536275     History of Changes
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 )
First Posted: February 22, 2012    Key Record Dates
Last Update Posted: June 22, 2017
Last Verified: June 2017

Keywords provided by Greet Van den Berghe, Katholieke Universiteit Leuven:
critical illness
children
nutrition
metabolism

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes