Effect of Malnutrition on Liver and Spleen Stiffness in Children (SWE)

Mehmet Akif AĞIR

Status: Enrolling

Conditions: Malnutrition in Children; Liver Stiffness; Shear Wave Elastography; Spleen Stiffness

Treatments: Diagnostic Test: Shear Wave Elastography

Study type: Observational

Funder types: Other

Identifiers

NCT06932445

2025/201

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 1 month to 18 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

300 participants in 2 patient groups

Malnutrition Group

Description:

Children diagnosed with malnutrition based on World Health Organization (WHO) criteria. Participants in this group will undergo shear wave elastography to evaluate liver and spleen stiffness.

Treatment:

Diagnostic Test: Shear Wave Elastography

Healthy Control Group

Description:

Age- and sex-matched healthy children with no known chronic diseases. These participants will also undergo shear wave elastography to allow comparison of organ stiffness values with the malnutrition group.

Treatment:

Diagnostic Test: Shear Wave Elastography