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

NCT06716229 | Not Yet Recruiting

• 1 other identifier: 03FM24D008
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Critically Ill Children; Nutritional Support

Keywords

Critically Ill children; Nutritional support

Outcome Measures

Primary Outcomes (1)

• 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

Eligibility Criteria

• Age: 1 Month - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MPH D Raul Copana-Olmos: lead
• Universidad Mayor de San Simón: collaborator
• Hospital del Nino Manuel Ascencio Villarroel: collaborator

Study Sites (2)

Hospital del Nino Manuel Ascencio Villarroel

Cochabamba, Cercado, 3119, Bolivia

Location

Universidad Mayor de San Simon

Cochabamba, Cercado, 3119, Bolivia

Location

Related Publications (12)

• 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.

  PMID: 32771283 BACKGROUND

• 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.

  PMID: 24403379 BACKGROUND

• 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.

  PMID: 27355525 BACKGROUND

• 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.

  PMID: 24113283 BACKGROUND

• 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.

  PMID: 30283765 BACKGROUND

• 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.

  PMID: 22564954 BACKGROUND

• 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.

  PMID: 32073189 BACKGROUND

• 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.

  PMID: 28686844 BACKGROUND

• 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.

  PMID: 29576361 BACKGROUND

• 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.

  PMID: 32077997 BACKGROUND

• 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.

  PMID: 36289081 BACKGROUND

• 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.

  PMID: 25377402 BACKGROUND

Central Study Contacts

Raul Copana-Olmos, MSC MD

CONTACT

+591 72256161; r.copana@umss.edu.bo

Ada Armaza-Cespedes, MSC MD

CONTACT

+591 72784613; a.armaza.med@umss.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: December 4, 2024
• Study Start: April 6, 2025
• Primary Completion: November 28, 2025
• Study Completion: December 19, 2025
• Last Updated: March 14, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Starting in January 2026

Locations

BO (2)