Standardized Nutritional Management of Pediatric Patients With Solid Tumors

Официальное название

Nutrition Strategies and Malnutrition Assessment Management Systems for Preventing Malnutrition in Children With Solid Tumors: an Exploratory Intervention Study

Обзор

The purpose of this study is to establish a standardized nutrition intervention procedure for children with solid tumors, and to explore the effectiveness and clinical applicability of standardized nutrition management and short peptide-based enteral nutrition intervention for improving the nutritional status of children with malignant solid tumors. After admission, patients in the intervention group will receive standardized nutrition management provided by a nutrition support team composed of dietitians, nutritionists, clinicians, and nursing teams. Basic information, including diet, enteral and parenteral nutrition, nutritional status and clinical data, will be collected during the study.

Вмешательства

• Пищевая добавка Standardized nutritional management
  The children will follow the five-step treatment principle of malnutrition. Diet + nutrition education is the basic way, which is successively promoted to diet + oral nutrition supplement, enteral nutrition, partial enteral nutrition + supplementary parenteral nutrition, and total parenteral nutrition. When a nutritional treatment does not meet 60% of the target energy requirements for 3 to 5 days, the upper step of the treatment can be selected. For infants or newborns, when 75-80% of the targe
• Пищевая добавка Standardized nutritional management + short peptide ONS
  During the study period, an additional 3 months of short peptide ONS enteral nutrition intervention is expected to be performed in children enrolled from Dec 1, 2024 to Feb 28, 2025 to explore the improvement of the nutritional status of the children. Short peptide type ONS 30ml/(kg.d) will be taken orally for children under 3 years old, and 20ml/(kg.d) for children over 3 years old. Due to conditional restrictions, standardized nutritional management + short peptide ONS intervention is only car

Первичные конечные точки

• Weight for age Z score [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• height/length for age Z score [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• BMI for age Z score [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]

Вторичные конечные точки (5)

• dietary intake [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• serum albumin [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• serum prealbumin [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• hemoglobin [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]
• electrolytes [Срок оценки: 1, 2, 3, 6, 12, 18, and 24 months after enrollment]

Критерии участия

• Male and female, age 0-18 years old
• Pathological diagnosis is malignant solid tumor with untreated initial onset

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Китай · 1 центр

• Children's Hospital of Fudan University — Шанхай

Публикации

• Olveira G, Tapia MJ, Ocon J, Cabrejas-Gomez C, Ballesteros-Pomar MD, Vidal-Casariego A, Arraiza-Irigoyen C, Olivares J, Conde-Garcia MC, Garcia-Manzanares A, Botella-Romero F, Quilez-Toboso RP, Matia P, Rubio MA, Chicharro L, Burgos R, Pujante P, Ferrer M, Zugasti A, Petrina E, Manjon L, Dieguez M, Carrera MJ, Vila-Bundo A, Urgeles JR, Aragon-Valera C, Sanchez-Vilar O, Breton I, Garcia-Peris P, Mu PMID 25441588
• White JV, Guenter P, Jensen G, Malone A, Schofield M; Academy Malnutrition Work Group; A.S.P.E.N. Malnutrition Task Force; A.S.P.E.N. Board of Directors. Consensus statement: Academy of Nutrition and Dietetics and American Society for Parenteral and Enteral Nutrition: characteristics recommended for the identification and documentation of adult malnutrition (undernutrition). JPEN J Parenter Entera PMID 22535923
• Hulst JM, Zwart H, Hop WC, Joosten KF. Dutch national survey to test the STRONGkids nutritional risk screening tool in hospitalized children. Clin Nutr. 2010 Feb;29(1):106-11. doi: 10.1016/j.clnu.2009.07.006. Epub 2009 Aug 13. PMID 19682776
• Mohamed Elfadil O, Steien DB, Narasimhan R, Velapati SR, Epp L, Patel I, Patel J, Hurt RT, Mundi MS. Transition to peptide-based diet improved enteral nutrition tolerance and decreased healthcare utilization in pediatric home enteral nutrition. JPEN J Parenter Enteral Nutr. 2022 Mar;46(3):626-634. doi: 10.1002/jpen.2202. Epub 2021 Jul 19. PMID 34145597
• Leonard M, Caldari D, Mas E, Lambe C, Comte A, Ley D, Peretti N, Borderon C, Marinier E, Coste ME, Lamireau T, Rubio A, Turquet A, Dubern B, Dabadie A, Gautry J, Kyheng M, Guimber D, Gottrand F. Experience of Using a Semielemental Formula for Home Enteral Nutrition in Children: A Multicenter Cross-sectional Study. J Pediatr Gastroenterol Nutr. 2019 Apr;68(4):585-590. doi: 10.1097/MPG.0000000000002 PMID 30896609
• Brinksma A, Sanderman R, Roodbol PF, Sulkers E, Burgerhof JG, de Bont ES, Tissing WJ. Malnutrition is associated with worse health-related quality of life in children with cancer. Support Care Cancer. 2015 Oct;23(10):3043-52. doi: 10.1007/s00520-015-2674-0. Epub 2015 Mar 10. PMID 25752883
• Becker P, Carney LN, Corkins MR, Monczka J, Smith E, Smith SE, Spear BA, White JV; Academy of Nutrition and Dietetics; American Society for Parenteral and Enteral Nutrition. Consensus statement of the Academy of Nutrition and Dietetics/American Society for Parenteral and Enteral Nutrition: indicators recommended for the identification and documentation of pediatric malnutrition (undernutrition). N PMID 25422273
• Arends J, Bachmann P, Baracos V, Barthelemy N, Bertz H, Bozzetti F, Fearon K, Hutterer E, Isenring E, Kaasa S, Krznaric Z, Laird B, Larsson M, Laviano A, Muhlebach S, Muscaritoli M, Oldervoll L, Ravasco P, Solheim T, Strasser F, de van der Schueren M, Preiser JC. ESPEN guidelines on nutrition in cancer patients. Clin Nutr. 2017 Feb;36(1):11-48. doi: 10.1016/j.clnu.2016.07.015. Epub 2016 Aug 6. PMID 27637832

Идентификаторы

NCT: NCT06730204 · (2023)136

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗