Early Versus Late Parenteral Nutrition in the Pediatric Intensive Care Unit
NCT ID: NCT01536275
Last Updated: 2024-02-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
1440 participants
INTERVENTIONAL
2012-06-30
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Early parenteral nutrition
Parenteral nutrition supplements insufficient enteral nutrition from admission to ICU according to the current standard of care per center
No interventions assigned to this group
Late parenteral nutrition
Parenteral nutrition will be withheld during the first 7 days of ICU stay
Late parenteral nutrition
Withholding parenteral nutrition during the first 7 days of ICU stay
Interventions
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Late parenteral nutrition
Withholding parenteral nutrition during the first 7 days of ICU stay
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
17 Years
ALL
No
Sponsors
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Sophia Kindergeneeskunde
OTHER
Stollery Children's Hospital
OTHER
KU Leuven
OTHER
Responsible Party
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Greet Van den Berghe
Head of Dept Intensive Care Medicine
Principal Investigators
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Greet Van den Berghe, MD PhD
Role: PRINCIPAL_INVESTIGATOR
KU Leuven
Locations
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Dept Intensive Care Medicine
Leuven, , Belgium
Stollery Children's Hospital
Edmonton, Alberta, Canada
Erasmus MC Sophia Kinderziekenhuis
Rotterdam, , Netherlands
Countries
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References
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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.
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.
Nakano FK, Dulfer K, Vanhorebeek I, Wouters PJ, Verbruggen SC, Joosten KF, Guiza Grandas F, Vens C, Van den Berghe G. Predicting adverse long-term neurocognitive outcomes after pediatric intensive care unit admission. Comput Methods Programs Biomed. 2024 Jun;250:108166. doi: 10.1016/j.cmpb.2024.108166. Epub 2024 Apr 10.
Veldscholte K, Hulst JM, Eveleens RD, de Jonge RCJ, de Koning BAE, van den Berg SAA, van der Wal R, Ruijter GJG, Rizopoulos D, Vanhorebeek I, Gunst J, Casaer M, Van den Berghe G, Joosten KFM, Verbruggen SCAT. Gastrointestinal Biomarkers and Their Association with Feeding in the First Five Days of Pediatric Critical Illness. J Pediatr Gastroenterol Nutr. 2023 Dec 1;77(6):811-818. doi: 10.1097/MPG.0000000000003950. Epub 2023 Sep 20.
Verlinden I, Coppens G, Vanhorebeek I, Guiza F, Derese I, Wouters PJ, Joosten KF, Verbruggen SC, Van den Berghe G. Long-term impact of paediatric critical illness on the difference between epigenetic and chronological age in relation to physical growth. Clin Epigenetics. 2023 Jan 14;15(1):8. doi: 10.1186/s13148-023-01424-w.
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.
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.
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.
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.
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.
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.
Hordijk J, Verbruggen S, Vanhorebeek I, Guiza F, Wouters P, Van den Berghe G, Joosten K, Dulfer K. Health-related quality of life of children and their parents 2 years after critical illness: pre-planned follow-up of the PEPaNIC international, randomized, controlled trial. Crit Care. 2020 Jun 16;24(1):347. doi: 10.1186/s13054-020-03059-2.
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.
van Puffelen E, Hulst JM, Vanhorebeek I, Dulfer K, Van den Berghe G, Verbruggen SCAT, Joosten KFM. Outcomes of Delaying Parenteral Nutrition for 1 Week vs Initiation Within 24 Hours Among Undernourished Children in Pediatric Intensive Care: A Subanalysis of the PEPaNIC Randomized Clinical Trial. JAMA Netw Open. 2018 Sep 7;1(5):e182668. doi: 10.1001/jamanetworkopen.2018.2668.
Verstraete S, Verbruggen SC, Hordijk JA, Vanhorebeek I, Dulfer K, Guiza F, van Puffelen E, Jacobs A, Leys S, Durt A, Van Cleemput H, Eveleens RD, Garcia Guerra G, Wouters PJ, Joosten KF, Van den Berghe G. Long-term developmental effects of withholding parenteral nutrition for 1 week in the paediatric intensive care unit: a 2-year follow-up of the PEPaNIC international, randomised, controlled trial. Lancet Respir Med. 2019 Feb;7(2):141-153. doi: 10.1016/S2213-2600(18)30334-5. Epub 2018 Sep 14.
Verstraete S, Vanhorebeek I, van Puffelen E, Derese I, Ingels C, Verbruggen SC, Wouters PJ, Joosten KF, Hanot J, Guerra GG, Vlasselaers D, Lin J, Van den Berghe G. Leukocyte telomere length in paediatric critical illness: effect of early parenteral nutrition. Crit Care. 2018 Feb 21;22(1):38. doi: 10.1186/s13054-018-1972-6.
van Puffelen E, Polinder S, Vanhorebeek I, Wouters PJ, Bossche N, Peers G, Verstraete S, Joosten KFM, Van den Berghe G, Verbruggen SCAT, Mesotten D. Cost-effectiveness study of early versus late parenteral nutrition in critically ill children (PEPaNIC): preplanned secondary analysis of a multicentre randomised controlled trial. Crit Care. 2018 Jan 15;22(1):4. doi: 10.1186/s13054-017-1936-2.
Fivez T, Kerklaan D, Mesotten D, Verbruggen S, Wouters PJ, Vanhorebeek I, Debaveye Y, Vlasselaers D, Desmet L, Casaer MP, Garcia Guerra G, Hanot J, Joffe A, Tibboel D, Joosten K, Van den Berghe G. Early versus Late Parenteral Nutrition in Critically Ill Children. N Engl J Med. 2016 Mar 24;374(12):1111-22. doi: 10.1056/NEJMoa1514762. Epub 2016 Mar 15.
Fivez T, Kerklaan D, Verbruggen S, Vanhorebeek I, Verstraete S, Tibboel D, Guerra GG, Wouters PJ, Joffe A, Joosten K, Mesotten D, Van den Berghe G. Impact of withholding early parenteral nutrition completing enteral nutrition in pediatric critically ill patients (PEPaNIC trial): study protocol for a randomized controlled trial. Trials. 2015 May 1;16:202. doi: 10.1186/s13063-015-0728-8.
Other Identifiers
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2012-000811-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ML8052
Identifier Type: OTHER
Identifier Source: secondary_id
NL38772.000.12
Identifier Type: OTHER
Identifier Source: secondary_id
IWT-TBM 110685
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
PEPaNIC
Identifier Type: -
Identifier Source: org_study_id
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