Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

Not Applicable

Active, not recruiting

• Conditions: Children; Critical Illness
• Interventions: Other: Late parenteral nutrition

• Registration Number: NCT01536275
• Lead Sponsor: KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-02-16
• Study First Submitted QC: 2012-02-21
• Study First Posted: 2012-02-22
• Study Start: 2012-06
• Primary Completion: 2016-03
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-09
• Last Update Posted: 2024-02-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1440

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Late parenteral nutrition	Late parenteral nutrition	Parenteral nutrition will be withheld during the first 7 days of ICU stay

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Stollery Children's Hospital; 🇨🇦 Edmonton, Alberta, Canada

Dept Intensive Care Medicine; 🇧🇪 Leuven, Belgium

Erasmus MC Sophia Kinderziekenhuis; 🇳🇱 Rotterdam, Netherlands