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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malnutrition Group | 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. |
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| Healthy Control Group | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Liver stiffness value (kPa) | Liver stiffness will be measured in kilopascals (kPa) using shear wave elastography. The average of three valid measurements will be recorded for each participant. | At baseline (single time point assessment) |
| Spleen stiffness value (kPa) | Spleen stiffness will be measured in kilopascals (kPa) using shear wave elastography. Similar to liver, the average of three valid measurements will be used. | At baseline |
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Inclusion Criteria:
Exclusion Criteria:
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This study will include children aged 6 to 18 years, divided into two groups:
Both groups will undergo shear wave elastography to measure liver and spleen stiffness.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mehmet Akif AGIR, Medical Doctor | Contact | +905052910809 | mehmetakif_68@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selçuk University Faculty of Medicine | Recruiting | Konya | Konya | 42130 | Turkey (Türkiye) |
The individual participant data will be shared upon request with qualified researchers, subject to institutional review and approval. Data sharing will be conducted in accordance with the university's data protection policies.
January 2026-January 2028
The individual participant data (IPD) will be accessible to qualified researchers upon request. Access will be granted following the approval of the Institutional Review Board (IRB) or relevant ethics committee. Researchers will be provided with access to de-identified data, including liver and spleen stiffness measurements, to ensure participant privacy. Access will be granted through a secure data-sharing platform or through direct data transfer from the research team. Data access will be subject to the terms and conditions of the institution's data-sharing policy.
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| ID | Term |
|---|---|
| D015362 | Child Nutrition Disorders |
| D044342 | Malnutrition |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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