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

Primary Purpose

Critical Illness, Children

Status

Recruiting

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Late parenteral nutrition

About this trial

This is an interventional treatment trial for Critical Illness focused on measuring critical illness, children, nutrition, metabolism

Eligibility Criteria

undefined - 17 Years (Child)All SexesDoes not accept 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

Sites / Locations

Dept Intensive Care MedicineRecruiting
Stollery Children's Hospital
Erasmus MC Sophia KinderziekenhuisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Early parenteral nutrition

Late parenteral nutrition

Arm Description

Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center

Parenteral nutrition will be withheld during the first 7 days of ICU stay

Outcomes

Primary Outcome Measures

Incidence of new infection during ICU stay

Duration of ICU dependency (crude stay days and time to alive discharge from ICU)

Secondary Outcome Measures

Mortality

Time to alive discharge from hospital

Incidence of hypoglycaemia during ICU stay

Time to final weaning from mechanical respiratory support

Incidence of liver dysfunction during ICU stay

Need for haemodynamic support during ICU stay

Incidence of new kidney injury during ICU stay

Duration of antibiotics treatment during ICU stay

Number of readmissions to the ICU

Amount of calories delivered during the ICU stay and in subset markers of feeding intolerance

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

Structural and or functional differences in muscle tissue during ICU stay

biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples

with healthy matched control group

functional and neurocognitive development

with healthy matched control group

health economy analysis

total health care costs during hospital stay

Full Information

NCT ID

NCT01536275

First Posted

February 16, 2012

Last Updated

March 8, 2022

Sponsor

KU Leuven

Collaborators

Sophia Kindergeneeskunde, Stollery Children's Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01536275

Brief Title

Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

Acronym

PEPaNIC

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Recruiting

Study Start Date

June 2012 (undefined)

Primary Completion Date

October 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

KU Leuven

Collaborators

Sophia Kindergeneeskunde, Stollery Children's Hospital

4. Oversight

Data Monitoring Committee

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critical Illness, Children

Keywords

critical illness, children, nutrition, metabolism

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early parenteral nutrition

Arm Type

No Intervention

Arm Description

Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center

Arm Title

Late parenteral nutrition

Arm Type

Experimental

Arm Description

Parenteral nutrition will be withheld during the first 7 days of ICU stay

Intervention Type

Other

Intervention Name(s)

Late parenteral nutrition

Other Intervention Name(s)

Late PN

Intervention Description

Withholding parenteral nutrition during the first 7 days of ICU stay

Primary Outcome Measure Information:

Title

Incidence of new infection during ICU stay

Time Frame

during ICU stay and up to 90 days post-randomization

Title

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 Measure Information:

Title

Mortality

Time Frame

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

Title

Time to alive discharge from hospital

Time Frame

during hospital stay and up to 90 days post-randomization

Title

Incidence of hypoglycaemia during ICU stay

Time Frame

during the intervention window up to day 8 post-randomization

Title

Time to final weaning from mechanical respiratory support

Time Frame

during ICU stay and up to 90 days post-randomization

Title

Incidence of liver dysfunction during ICU stay

Time Frame

during ICU stay and up 90 days post-randomization

Title

Need for haemodynamic support during ICU stay

Time Frame

during ICU stay and up 90 days post-randomization

Title

Incidence of new kidney injury during ICU stay

Time Frame

during ICU stay and up 90 days post-randomization

Title

Duration of antibiotics treatment during ICU stay

Time Frame

during ICU stay and up to 90 days post-randomization

Title

Number of readmissions to the ICU

Time Frame

up to 90 days post-randomization

Title

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

Title

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

Time Frame

during ICU stay and up to 90 days post-randomization

Title

Structural and or functional differences in muscle tissue during ICU stay

Time Frame

during ICU stay and up to 90 days post-randomization

Title

biochemical, metabolic, endocrine, immunological, inflammatory and (epi)genetic markers on blood samples

Description

with healthy matched control group

Time Frame

up to 4 years post-randomization

Title

functional and neurocognitive development

Description

with healthy matched control group

Time Frame

up to 4 years post-randomization

Title

health economy analysis

Description

total health care costs during hospital stay

Time Frame

during index hospitalization

10. Eligibility

Sex

All

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tom Fivez, MD

Phone

003216340989

tom.fivez@uzleuven.be

First Name & Middle Initial & Last Name or Official Title & Degree

Dieter Mesotten, MD PhD

Phone

003216340977

dieter.mesotten@med.kuleuven.be

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Greet Van den Berghe, MD PhD

Organizational Affiliation

KU Leuven

Official's Role

Principal Investigator

Facility Information:

Facility Name

Dept Intensive Care Medicine

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tom Fivez, MD

Phone

003216340989

tom.fivez@uzleuven.be

First Name & Middle Initial & Last Name & Degree

Dieter Mesotten, MD PhD

Phone

003216340977

dieter.mesotten@med.kuleuven.be

First Name & Middle Initial & Last Name & Degree

Dieter Mesotten, MD PhD

First Name & Middle Initial & Last Name & Degree

Tom Fivez, MD

Facility Name

Stollery Children's Hospital

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2B7

Country

Canada

Individual Site Status

Active, not recruiting

Facility Name

Erasmus MC Sophia Kinderziekenhuis

City

Rotterdam

ZIP/Postal Code

3015

Country

Netherlands

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sascha Verbruggen, MD, PhD

Phone

0031107036669

s.verbruggen@erasmusmc.nl

First Name & Middle Initial & Last Name & Degree

Koen Joosten, MD, PhD

Phone

0031107040704

k.joosten@erasmusmc.nl

12. IPD Sharing Statement

Citations:

PubMed Identifier

21714640

Citation

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.

Results Reference

background

PubMed Identifier

19176240

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.

Results Reference

background

PubMed Identifier

36384393

Citation

Coppens G, Vanhorebeek I, Verlinden I, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Guiza F, Van den Berghe G. Assessment of aberrant DNA methylation two years after paediatric critical illness: a pre-planned secondary analysis of the international PEPaNIC trial. Epigenetics. 2023 Dec;18(1):2146966. doi: 10.1080/15592294.2022.2146966. Epub 2022 Nov 16.

Results Reference

derived

PubMed Identifier

35549984

Citation

Vanhorebeek I, Jacobs A, Mebis L, Dulfer K, Eveleens R, Van Cleemput H, Wouters PJ, Verlinden I, Joosten K, Verbruggen S, Van den Berghe G. Impact of critical illness and withholding of early parenteral nutrition in the pediatric intensive care unit on long-term physical performance of children: a 4-year follow-up of the PEPaNIC randomized controlled trial. Crit Care. 2022 May 12;26(1):133. doi: 10.1186/s13054-022-04010-3.

Results Reference

derived

PubMed Identifier

35522534

Citation

Verlinden I, Guiza F, Dulfer K, Van Cleemput H, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Physical, Emotional/Behavioral, and Neurocognitive Developmental Outcomes From 2 to 4 Years After PICU Admission: A Secondary Analysis of the Early Versus Late Parenteral Nutrition Randomized Controlled Trial Cohort. Pediatr Crit Care Med. 2022 Aug 1;23(8):580-592. doi: 10.1097/PCC.0000000000002971. Epub 2022 May 9.

Results Reference

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PubMed Identifier

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Citation

Jacobs A, Guiza F, Verlinden I, Dulfer K, Garcia Guerra G, Joosten K, Verbruggen SC, Vanhorebeek I, Van den Berghe G. Differential DNA methylation by early versus late parenteral nutrition in the PICU: a biological basis for its impact on emotional and behavioral problems documented 4 years later. Clin Epigenetics. 2021 Jul 27;13(1):146. doi: 10.1186/s13148-021-01124-3.

Results Reference

derived

PubMed Identifier

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Citation

Verlinden I, Dulfer K, Vanhorebeek I, Guiza F, Hordijk JA, Wouters PJ, Guerra GG, Joosten KF, Verbruggen SC, Van den Berghe G. Role of age of critically ill children at time of exposure to early or late parenteral nutrition in determining the impact hereof on long-term neurocognitive development: A secondary analysis of the PEPaNIC-RCT. Clin Nutr. 2021 Mar;40(3):1005-1012. doi: 10.1016/j.clnu.2020.07.004. Epub 2020 Jul 14.

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PubMed Identifier

32562632

Citation

Jacobs A, Dulfer K, Eveleens RD, Hordijk J, Van Cleemput H, Verlinden I, Wouters PJ, Mebis L, Guerra GG, Joosten K, Verbruggen SC, Guiza F, Vanhorebeek I, Van den Berghe G. Long-term developmental effect of withholding parenteral nutrition in paediatric intensive care units: a 4-year follow-up of the PEPaNIC randomised controlled trial. Lancet Child Adolesc Health. 2020 Jul;4(7):503-514. doi: 10.1016/S2352-4642(20)30104-8.

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PubMed Identifier

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Citation

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PubMed Identifier

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Citation

van Puffelen E, Hulst JM, Vanhorebeek I, Dulfer K, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Effect of late versus early initiation of parenteral nutrition on weight deterioration during PICU stay: Secondary analysis of the PEPaNIC randomised controlled trial. Clin Nutr. 2020 Jan;39(1):104-109. doi: 10.1016/j.clnu.2019.02.014. Epub 2019 Mar 4.

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PubMed Identifier

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Citation

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Citation

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PubMed Identifier

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Citation

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Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit

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