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NCT Number: NCT06932445

Effect of Malnutrition on Liver and Spleen Stiffness in Children

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.

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Selçuk University Faculty of Medicine

Konya, 42130, Turkey (Türkiye)

Location status: Recruiting

Location contact

Mehmet Akif AGIR, MD

CONTACT

[email protected]

+905052910809

Mehmet Akif AGIR, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Shear Wave Elastography

Diagnostic Test

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.

Other names: SWE

Primary outcomes

  1. Liver stiffness value (kPa)

    Time frame: At baseline (single time point assessment)

    Liver stiffness will be measured in kilopascals (kPa) using shear wave elastography. The average of three valid measurements will be recorded for each participant.

  2. Spleen stiffness value (kPa)

    Time frame: At baseline

    Spleen stiffness will be measured in kilopascals (kPa) using shear wave elastography. Similar to liver, the average of three valid measurements will be used.

Study contacts

Contact information is provided by the study sponsor or research team.

Mehmet Akif AGIR, Medical Doctor

CONTACT

[email protected]

+905052910809

Sponsors and collaborators

Lead sponsor

Mehmet Akif AĞIR

Other

Registry information

Official study title

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

Acronym: SWE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2025
Registry last updated
Apr 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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