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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06146452
Other study ID # PPC Micronutrient
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date October 1, 2023
Est. completion date October 1, 2024

Study information

Verified date April 2024
Source Dr. Behcet Uz Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The goal of this observational study is to determine the micronutrient levels in patients in the Pediatric Palliative Care Clinic. The main question it aims to answer are: • What is the frequency of micronutrient deficiencies in pediatric palliative care patients?


Description:

Palliative care is an important health service provided with a multidisciplinary approach to improve the quality of life of children with progressive and life-threatening diseases and to manage symptoms effectively. This service aims to provide children with a good life experience by meeting the physical, psychological, social and spiritual needs of patients and their families. Micronutrients contain important nutritional components such as vitamins, minerals and other nutrients that are essential for maintaining normal functions of the body. Micronutrient deficiencies affect at least half of children under five years of age. In a study conducted in pediatric oncology patients, micronutrient deficiency was shown to have a frequency of 74%, and selenium deficiency in particular negatively affected clinical outcomes. Contrary to recommended nutrient intakes (RNI) and expert opinion for healthy children, evidence-based recommendations for micronutrient requirements in critically ill children are not available. However, in pediatric palliative care, if the nutritional history indicates inadequate nutritional intake and/or growth indicates malnutrition, nutritional deficiencies that may have systemic effects, such as iron and vitamin B12 deficiency, need to be investigated. This article aims to fill the gap in the literature by determining the micronutrient levels of pediatric palliative care patients hospitalized in the Pediatric Palliative Care Clinic. The research aims to contribute to a better understanding of the nutritional needs of patients in pediatric palliative care and to direct treatment approaches more effectively.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 249
Est. completion date October 1, 2024
Est. primary completion date September 1, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 1 Month to 18 Years
Eligibility Inclusion Criteria: - Hospitalized in a pediatric palliative care service Exclusion Criteria: - Patients who are hospitalized without having chronic, complex, progressive or life-threatening diseases (for off-label reasons)

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Not
Not

Locations

Country Name City State
Turkey Dr. Behcet Uz Children's Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
Dr. Behcet Uz Children's Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

Marino LV, Valla FV, Beattie RM, Verbruggen SCAT. Micronutrient status during paediatric critical illness: A scoping review. Clin Nutr. 2020 Dec;39(12):3571-3593. doi: 10.1016/j.clnu.2020.04.015. Epub 2020 Apr 22. — View Citation

Revuelta Iniesta R, Gerasimidis K, Paciarotti I, McKenzie JM, Brougham MF, Wilson DC. Micronutrient status influences clinical outcomes of paediatric cancer patients during treatment: A prospective cohort study. Clin Nutr. 2021 May;40(5):2923-2935. doi: 1 — View Citation

Verbov J. More consultant dermatologists are needed. J R Coll Physicians Lond. 1990 Jul;24(3):249. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary the presence of micronutrient deficiency Presence of micronutrient deficiency in patients hospitalized in pediatric palliative care clinic 12/01/2023-01/01/2024
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