Relationship of Nutritional Support for Critically Ill Children with Clinical Outcomes in a Pediatric Hospital in Bolivia (NutPeBol) (NutPeBol)

Relationship of Nutritional Support for Critically Ill Children with Clinical Outcomes in a Pediatric Hospital in Bolivia in 2025 (NutPeBol)

The aim of this observational study is to learn about the characteristics of nutritional support in critically ill children. The primary question to be answered is Is there an association between nutritional support of the critically ill child and clinical and hospital outcomes in children admitted to a pediatric referral center? Patients will be followed throughout their hospitalization, with a step-by-step evaluation of the nutritional support received through standard care and a review of the results obtained in the patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Nutritional Support; Critically Ill Children

Detailed Description

The study aims to know the type and characteristics of nutritional support received by critically ill children hospitalized in Bolivian hospitals; to follow them during their hospitalization to verify their weight, nutritional status and the nutritional support they receive; to understand which types of nutritional support offer better clinical and hospital outcomes; finally, to be able to propose some guidelines to physicians, through guidelines or other tools for the dissemination of scientific information, in order to benefit more children.

• Study Type: Observational
• Enrollment (Estimated): 56

Contacts and Locations

• Study Contact: Name: Raul Copana-Olmos, MSC MD; Phone Number: +591 72256161; Email: r.copana@umss.edu.bo
• Study Contact Backup: Name: Ada Armaza-Cespedes, MSC MD; Phone Number: +591 72784613; Email: a.armaza.med@umss.edu

Study Locations

• Bolivia
  • Cercado
    • Cochabamba, Cercado, Bolivia, 3119
      • Hospital del Nino Manuel Ascencio Villarroel
    • Cochabamba, Cercado, Bolivia, 3119
      • Universidad Mayor de San Simon
      • Contact: Raul Copana-Olmos, MSC MD; Phone Number: +591 72256161; Email: r.copana@umss.edu.bo
      • Contact: Ada Armaza-Cespedes, MSC MD
      • Contact: Marcos Medina-Bustos, MSC MD
      • Contact: Raul Copana-Olmos, MSC MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Critically ill children with acute conditions who are admitted to the PICU, intermediate care or wards of a pediatric referral hospital

Description

Inclusion Criteria:

• Admitted to intensive care or intermediate care in hospital wards
• Complete clinical and anthropometric data.

Exclusion Criteria:

• Congenital or acquired chronic disease affecting growth (secondary malnutrition)
• On medication (corticosteroids, immunoglobulins, albumin)
• Burn patients, with prosthetic implants, postoperative of large tumor resections.
• Unknown history of pre-referral hospital management or hospitalized in other health facilities.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in mid-upper arm circumference (MUAC) <11.5 cm (115 mm), weight-for-height z-score (WHZ) <-3, or bilateral pitting edema in critically ill children admitted to a pediatric hospital.	Participants who received nutritional support achieved changes from baseline in mid-upper arm circumference (MUAC) <11.5 cm (115 mm), weight-for-height z-score (WHZ) <-3, or bilateral pitting edema in critically ill children.	From March 2025 to March 2026

Collaborators and Investigators

• Sponsor: MPH D Raul Copana-Olmos
• Collaborators: Universidad Mayor de San Simón; Hospital del Nino Manuel Ascencio Villarroel

Publications and helpful links

General Publications

• Mehta NM, Bechard LJ, Cahill N, Wang M, Day A, Duggan CP, Heyland DK. Nutritional practices and their relationship to clinical outcomes in critically ill children--an international multicenter cohort study*. Crit Care Med. 2012 Jul;40(7):2204-11. doi: 10.1097/CCM.0b013e31824e18a8.
• Fraipont V, Preiser JC. Energy estimation and measurement in critically ill patients. JPEN J Parenter Enteral Nutr. 2013 Nov;37(6):705-13. doi: 10.1177/0148607113505868. Epub 2013 Oct 10.
• Mikhailov TA, Kuhn EM, Manzi J, Christensen M, Collins M, Brown AM, Dechert R, Scanlon MC, Wakeham MK, Goday PS. Early enteral nutrition is associated with lower mortality in critically ill children. JPEN J Parenter Enteral Nutr. 2014 May;38(4):459-66. doi: 10.1177/0148607113517903. Epub 2014 Jan 8.
• Tume LN, Valla FV, Joosten K, Jotterand Chaparro C, Latten L, Marino LV, Macleod I, Moullet C, Pathan N, Rooze S, van Rosmalen J, Verbruggen SCAT. Nutritional support for children during critical illness: European Society of Pediatric and Neonatal Intensive Care (ESPNIC) metabolism, endocrine and nutrition section position statement and clinical recommendations. Intensive Care Med. 2020 Mar;46(3):411-425. doi: 10.1007/s00134-019-05922-5. Epub 2020 Feb 20.
• Brossier DW, Tume LN, Briant AR, Jotterand Chaparro C, Moullet C, Rooze S, Verbruggen SCAT, Marino LV, Alsohime F, Beldjilali S, Chiusolo F, Costa L, Didier C, Ilia S, Joram NL, Kneyber MCJ, Kuhlwein E, Lopez J, Lopez-Herce J, Mayberry HF, Mehmeti F, Mierzewska-Schmidt M, Minambres Rodriguez M, Morice C, Pappachan JV, Porcheret F, Reis Boto L, Schlapbach LJ, Tekguc H, Tziouvas K, Parienti JJ, Goyer I, Valla FV; Metabolism Endocrinology and Nutrition section of the European Society of Pediatric and Neonatal Intensive Care (ESPNIC). ESPNIC clinical practice guidelines: intravenous maintenance fluid therapy in acute and critically ill children- a systematic review and meta-analysis. Intensive Care Med. 2022 Dec;48(12):1691-1708. doi: 10.1007/s00134-022-06882-z. Epub 2022 Oct 26. Erratum In: Intensive Care Med. 2023 Jan;49(1):128-129. doi: 10.1007/s00134-022-06933-5. Intensive Care Med. 2023 Sep;49(9):1151-1153. doi: 10.1007/s00134-023-07119-3.
• Amano K, Maeda I, Ishiki H, Miura T, Hatano Y, Tsukuura H, Taniyama T, Matsumoto Y, Matsuda Y, Kohara H, Morita T, Mori M; East-Asian collaborative cross-cultural Study to Elucidate the Dying process (EASED) Investigators. Effects of enteral nutrition and parenteral nutrition on survival in patients with advanced cancer cachexia: Analysis of a multicenter prospective cohort study. Clin Nutr. 2021 Mar;40(3):1168-1175. doi: 10.1016/j.clnu.2020.07.027. Epub 2020 Jul 31.
• Ward SL, Gildengorin V, Valentine SL, Sapru A, Curley MA, Thomas N, Willson DF, Flori HR. Impact of Weight Extremes on Clinical Outcomes in Pediatric Acute Respiratory Distress Syndrome. Crit Care Med. 2016 Nov;44(11):2052-2059. doi: 10.1097/CCM.0000000000001857.
• Mtaweh H, Tuira L, Floh AA, Parshuram CS. Indirect Calorimetry: History, Technology, and Application. Front Pediatr. 2018 Sep 19;6:257. doi: 10.3389/fped.2018.00257. eCollection 2018.
• Chima L, Mulrooney HM, Warren J, Madden AM. A systematic review and quantitative analysis of resting energy expenditure prediction equations in healthy overweight and obese children and adolescents. J Hum Nutr Diet. 2020 Jun;33(3):373-385. doi: 10.1111/jhn.12735. Epub 2020 Feb 19.
• Mehta NM, Skillman HE, Irving SY, Coss-Bu JA, Vermilyea S, Farrington EA, McKeever L, Hall AM, Goday PS, Braunschweig C. Guidelines for the Provision and Assessment of Nutrition Support Therapy in the Pediatric Critically Ill Patient: Society of Critical Care Medicine and American Society for Parenteral and Enteral Nutrition. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):706-742. doi: 10.1177/0148607117711387. Epub 2017 Jun 2.
• Larsen BMK, Beggs MR, Leong AY, Kang SH, Persad R, Garcia Guerra G. Can energy intake alter clinical and hospital outcomes in PICU? Clin Nutr ESPEN. 2018 Apr;24:41-46. doi: 10.1016/j.clnesp.2018.02.002. Epub 2018 Mar 2.
• Gold DL, Mihalov LK, Cohen DM. Evaluating the Pediatric Early Warning Score (PEWS) system for admitted patients in the pediatric emergency department. Acad Emerg Med. 2014 Nov;21(11):1249-56. doi: 10.1111/acem.12514.

Study record dates

Study Major Dates

• Study Start (Estimated): April 6, 2025
• Primary Completion (Estimated): November 28, 2025
• Study Completion (Estimated): December 19, 2025

Study Registration Dates

• First Submitted: October 30, 2024
• First Submitted That Met QC Criteria: November 28, 2024
• First Posted (Actual): December 4, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 11, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Nutritional support; Critically Ill children
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 03FM24D008

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All underlying IPDs that result in a publication
• IPD Sharing Time Frame: Starting in January 2026
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No