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

NCT ID: NCT06716229

Last Updated: 2025-03-14

Study Results

Results pending

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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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

56 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-06

Study Completion Date

2025-12-19

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Critically Ill Children Nutritional Support

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Mayor de San Simón

OTHER

Sponsor Role collaborator

Hospital del Nino Manuel Ascencio Villarroel

OTHER

Sponsor Role collaborator

MPH D Raul Copana-Olmos

OTHER

Sponsor Role lead

Responsible Party

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MPH D Raul Copana-Olmos

Assistant professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Hospital del Nino Manuel Ascencio Villarroel

Cochabamba, Cercado, Bolivia

Site Status

Universidad Mayor de San Simon

Cochabamba, Cercado, Bolivia

Site Status

Countries

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Bolivia

Central Contacts

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Raul Copana-Olmos, MSC MD

Role: CONTACT

+591 72256161

Ada Armaza-Cespedes, MSC MD

Role: CONTACT

+591 72784613

Facility Contacts

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Raul Copana-Olmos, MSC MD

Role: primary

+591 72256161

References

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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.

Reference Type BACKGROUND
PMID: 32771283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24403379 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27355525 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24113283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30283765 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22564954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32073189 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28686844 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29576361 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32077997 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36289081 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25377402 (View on PubMed)

Other Identifiers

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03FM24D008

Identifier Type: -

Identifier Source: org_study_id

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