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Recruiting NCT06932445

Effect of Malnutrition on Liver and Spleen Stiffness in Children

Observational Malnutrition in Children Liver Stiffness Spleen Stiffness Shear Wave Elastography

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In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Shear Wave Elastography.
Who it may be relevant to
Registry conditions: Malnutrition in Children, Liver Stiffness, Spleen Stiffness, Shear Wave Elastography. Basic parameters: 1 months — 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography

Overview

This prospective observational study aims to evaluate the effect of malnutrition on liver and spleen stiffness in children using shear wave elastography. Two groups of participants will be enrolled: children diagnosed with malnutrition and age-matched healthy controls. Organ stiffness measurements will be compared between the two groups to assess the impact of malnutrition on liver and spleen tissue properties.

Detailed description

This is a prospective observational study designed to investigate the effect of malnutrition on liver and spleen stiffness in children. The study will include two groups: children diagnosed with malnutrition according to WHO criteria, and age- and sex-matched healthy controls without any known chronic illness.

All participants will undergo shear wave elastography (SWE) to measure liver and spleen stiffness using standardized ultrasound protocols. Measurements will be performed by a pediatric radiologist blinded to the nutritional status of the participants.

The primary objective is to compare organ stiffness values between malnourished children and healthy controls. Secondary analyses will explore correlations between severity of malnutrition and stiffness values. The study aims to provide non-invasive insights into early organ-level changes associated with pediatric malnutrition.

Interventions

  • Diagnostic test Shear Wave Elastography
    Shear wave elastography will be used to measure liver and spleen stiffness in all participants. The procedure will be performed using standard ultrasound-based elastography protocols by a pediatric radiologist.

Primary outcome measures

  • Liver stiffness value (kPa) [Time frame: At baseline (single time point assessment)]
  • Spleen stiffness value (kPa) [Time frame: At baseline]

Eligibility criteria

Inclusion criteria

  • Children aged 6 to 18 years.
  • Diagnosis of malnutrition based on World Health Organization (WHO) criteria (for malnutrition group).
  • Healthy children without any chronic illness (for control group).

Exclusion criteria

  • Children with chronic diseases (e.g., liver disease, diabetes, immunocompromised conditions).
  • Children who have previously undergone liver or spleen surgery.
  • Children with inability to cooperate during elastography measurement.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

Turkey (Türkiye) · 1 center
  • Selçuk University Faculty of Medicine — Konya

Identifiers

NCT: NCT06932445 · 2025/201

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗