Clinical trial NCT06932445: Effect of Malnutrition on Liver and Spleen Stiffness in Children
Official title: Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Malnutrition in Children
Liver Stiffness
Spleen Stiffness
Shear Wave Elastography
Keywords: Malnutrition
Liver Stiffness
Spleen Stiffness
Shear Wave Elastography
Children
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2025-04-17
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include children aged 6 to 18 years, divided into two groups:

1. Malnutrition group: Children diagnosed with malnutrition according to World Health Organization (WHO) criteria.
2. Healthy control group: Age- and sex-matched healthy children with no known chronic illnesses.

Both groups will undergo shear wave elastography to measure liver and spleen stiffness.

Brief summary: 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.

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.

Primary outcomes:
measure: Liver stiffness value (kPa)
timeFrame: At baseline (single time point assessment)
measure: Spleen stiffness value (kPa)
timeFrame: At baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selçuk University Faculty of Medicine
Study officials:
References: