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Critically Ill ChildrenNutPeBolNCT06716229

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

An observational study of Critically Ill Children and Nutritional Support, run by MPH D Raul Copana-Olmos at 2 sites in Bolivia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 month to 15 years
Conditions the study is for
Critically Ill Children, Nutritional Support
How many people
56 participants
Where
2 sitesBolivia
Study dates
6 Apr 2025to 19 Dec 2025
How long will I take part?
4 Weeks
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 15 years
  • All sexes
  • No healthy volunteers
  • Child

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

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

Bolivia2 sites

  • Hospital del Nino Manuel Ascencio Villarroel

    Cochabamba, Cercado, 3119

  • Universidad Mayor de San Simon

    Cochabamba, Cercado, 3119

Other trials in Bolivia

About this study

Official title: 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.

Read the 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.

Keywords
Critically Ill children, Nutritional support

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From March 2025 to March 2026

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Dec 2024
  2. Study start6 Apr 2025
  3. Primary completion28 Nov 2025
  4. Study completion19 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
56 participants (actual)
Target duration
4 Weeks
IDs, dates and publications
ClinicalTrials.gov ID
NCT06716229
Sponsor's protocol ID
03FM24D008
Acronym
NutPeBol
Status last verified
Mar 2025
First submitted
30 Oct 2024
Last updated
18 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: All underlying IPDs that result in a publication

Publications

  • 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.

    PubMed 32771283

  • 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.

    PubMed 24403379

  • 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.

    PubMed 27355525

  • 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.

    PubMed 24113283

  • 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.

    PubMed 30283765

  • 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.

    PubMed 22564954

  • 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.

    PubMed 32073189

  • 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.

    PubMed 28686844

  • 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.

    PubMed 29576361

  • 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.

    PubMed 32077997

  • 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.

    PubMed 36289081

  • 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.

    PubMed 25377402

Questions about this trial

What is this clinical trial studying?

An observational study of Critically Ill Children and Nutritional Support, run by MPH D Raul Copana-Olmos at 2 sites in Bolivia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Bolivia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: From March 2025 to March 2026). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06716229, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2026.

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