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

C

Catholic University (KU) of Leuven

Status

Active, not recruiting

Conditions

Critical Illness
Children

Treatments

Other: Late parenteral nutrition

Study type

Interventional

Funder types

Other

Identifiers

NCT01536275
2012-000811-10 (EudraCT Number)
NL38772.000.12 (Other Identifier)
ML8052 (Other Identifier)
PEPaNIC
IWT-TBM 110685 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment

1,440 patients

Sex

All

Ages

Under 17 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

1,440 participants in 2 patient groups

Early parenteral nutrition
No Intervention group
Description:
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
Late parenteral nutrition
Experimental group
Description:
Parenteral nutrition will be withheld during the first 7 days of ICU stay
Treatment:
Other: Late parenteral nutrition

Trial contacts and locations

3

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Central trial contact

Dieter Mesotten, MD PhD; Tom Fivez, MD

Data sourced from clinicaltrials.gov

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