Effect of Malnutrition on Liver and Spleen Stiffness in Children
SWE
Impact of Malnutrition on Liver and Spleen Stiffness in Children Evaluated by Shear Wave Elastography
1 other identifier
observational
300
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2025
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 10, 2025
CompletedStudy Start
First participant enrolled
April 10, 2025
CompletedFirst Posted
Study publicly available on registry
April 17, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2025
CompletedApril 17, 2025
April 1, 2025
1 month
April 10, 2025
April 10, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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
Study Arms (2)
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.
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mehmet Akif AĞIRlead
Study Sites (1)
Selçuk University Faculty of Medicine
Konya, Konya, 42130, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Specialist in Pediatric Gastroenterology
Study Record Dates
First Submitted
April 10, 2025
First Posted
April 17, 2025
Study Start
April 10, 2025
Primary Completion
May 15, 2025
Study Completion
May 20, 2025
Last Updated
April 17, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- January 2026-January 2028
- Access Criteria
- 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.
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.