Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

Critical Illness Clinical Trial

— PEPaNIC  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01536275
• Other study ID #: PEPaNIC
• Secondary ID: 2012-000811-10ML
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2012
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: KU Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1440
• Est. completion date: December 2026
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Children
• Critical Illness

Intervention

Other:
• Late parenteral nutrition
Withholding parenteral nutrition during the first 7 days of ICU stay

Locations

Country	Name	City	State
Belgium	Dept Intensive Care Medicine	Leuven
Canada	Stollery Children's Hospital	Edmonton	Alberta
Netherlands	Erasmus MC Sophia Kinderziekenhuis	Rotterdam

Sponsors (3)

Lead Sponsor	Collaborator
KU Leuven	Sophia Kindergeneeskunde, Stollery Children's Hospital

Countries where clinical trial is conducted

Belgium,  Canada,  Netherlands, 

References & Publications (2)

Casaer MP, Mesotten D, Hermans G, Wouters PJ, Schetz M, Meyfroidt G, Van Cromphaut S, Ingels C, Meersseman P, Muller J, Vlasselaers D, Debaveye Y, Desmet L, Dubois J, Van Assche A, Vanderheyden S, Wilmer A, Van den Berghe G. Early versus late parenteral nutrition in critically ill adults. N Engl J Med. 2011 Aug 11;365(6):506-17. doi: 10.1056/NEJMoa1102662. Epub 2011 Jun 29. — View Citation

Vlasselaers D, Milants I, Desmet L, Wouters PJ, Vanhorebeek I, van den Heuvel I, Mesotten D, Casaer MP, Meyfroidt G, Ingels C, Muller J, Van Cromphaut S, Schetz M, Van den Berghe G. Intensive insulin therapy for patients in paediatric intensive care: a prospective, randomised controlled study. Lancet. 2009 Feb 14;373(9663):547-56. doi: 10.1016/S0140-6736(09)60044-1. Epub 2009 Jan 26. — View Citation

Outcome

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