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Skeletal Muscle UltrasonographyNCT06382766

Skeletal Muscle Ultrasonography in Detection of Malnutrition

An observational study of Skeletal Muscle Ultrasonography, run by Assiut University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children. To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional… Read more about this study

Who is it for?
Ages 1 month to 5 years
Conditions the study is for
Skeletal Muscle Ultrasonography
What is being tested?
Skeletal Muscle Ultrasonography
How many people
50 participants
Where
No sites listed yet
Study dates
Mar 2025to Mar 2026
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 month to 5 years
  • All sexes
  • No healthy volunteers
  • Child

Study population: Acute critically ill infants and children aged \> 1month- 5 years attending Assiut University Children Hospital

Who may be able to join

  • Acute critically ill infants and children aged \> 1month- 5 years .

Who cannot join

  • Neonates less than 1 month .
  • Children with muscle disorders .
  • Children with multiple congenital anomlies, genetic or chromosomal diseases.
  • Children with chronic illness or comorbid condition (T.B, diabetes, malignancy, etc..) .
  • children missed for follow up.

Trial locations and contacts

No sites are listed yet.

Ali Hussin Mohamed, assisstant lecturer contact

00201064320946

Alihussin@med.aun.edu.eg

About this study

Official title: Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome Among Critically Ill Children Attending Assiut University Children Hospital

  • To detect the role of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children.
  • To assess the accuracy and validity of muscle ultrasonography in assessment of the nutritional status of critically ill child compared with other different nutritional assessment tools .
Read the detailed description

Under nutrition is a public health problem worldwide, particularly among children under-five. Globally in 2020, about 149.2 million (22% of children under-five) and 45.4 million (6.7% of children under-five) were estimated to be stunted and wasted respectively . Undernutrition equally accounts for about 3.1 million deaths (45% of all deaths) among children under-five annually . This burden, however, is disproportionately borne by the African continent. In effect, two out of five (41% or 61.4 million children) stunted children and more than a quarter (27% or 12.1 million children) of all wasted children under-five live in the African continent. This burden varied across the country, greatest in rural localities and areas with ongoing humanitarian crisis.

Pediatric intensive care unit (PICU) admission rates for undernutrition in critically sick children range from 8.1 to 71.7%, despite variations in nutritional indices, the presence of chronic illness, age, and critical illness severity . Critically ill children can become undernourished more quickly than adults due to their lower body fat and muscle mass and higher per kilogram resting energy requirements. Complications from undernutrition can include more frequent infections, longer length of stay (LOS), and morbidity.

Underweight children admitted to the pediatric intensive care unit (PICU) have a higher mortality and PICU LOS, which increase with increasing severity of underweight. In light of this, early detection of undernutrition and the observation of nutritional status degradation might result in fast and appropriate nutritional therapies, which may improve clinical outcomes. Additionally, because most critically ill patients have reduced nutritional reserves, iatrogenic underfeeding and increasing malnutrition are further encouraged by prolonged fasting and frequent feeding pauses during intensive care unit (ICU) and hospital stays No single objective marker can be used to reliably predict protein-energy malnutrition or risk of nutrition-related complications in children; an assessment encompassing several markers is necessary. The diagnosis of malnutrition can be based on 6 different domains: (1) insufficient food and nutrition intake compared with nutrition requirements, (2) weight loss over time, (3) loss of muscle mass, (4) loss of fat mass, (5) fluid accumulation, and (6) measurably diminished grip strength. Hence, no single measure (either anthropometric or laboratory) by itself is an ideal measure of malnutrition.

Anthropometric measurements are essential components of nutrition screening and assessment of pediatric patients. The use of proper equipment, accurate measurement techniques, and appropriate reference data are necessary for obtaining and interpreting anthropometric data. Accurate height and length measurements can be difficult to obtain in ambulatory children and in some clinical situations (such as trauma, burn, and surgical patients who require the use of traction, castings, or dressings for large body wounds), accurate anthropometric measurements such as weight and height may be more difficult or impossible to obtain. Preliminary evidence suggests that muscle wasting also occurs in critically ill children, which could affect intensive care unit (ICU) course or long-term growth and development in children.

Identification of muscle wasting would thus be important in critically ill children, so as to be able to appropriately target optimal nutrition and physical interventions to reduce muscle wasting and risk of poor outcomes in these high-risk children. However, identifying muscle changes can be challenging in clinical practice. Current methods available, such as mid-arm circumference, may not accurately reflect muscle changes, while other methods such as computerized tomography (CT) or magnetic resonance imaging (MRI) are not easily conducted at bedside. Recently, ultrasonography has been used in adult critical care to visualize abnormalities and changes in muscle throughout the course of the ICU stay. Ultrasonography, an imaging technique that uses reflections of high-frequency sound waves directed at tissues, is noninvasive, fast, and cost-effective, and it has been suggested as a possible nutrition assessment tool in critically ill patients. Muscle ultrasound enables early detection of skeletal muscle wasting, which is associated with histological changes in muscle as well as functional impairment in adults. Muscle ultrasonography has also traditionally been used to quantify and qualify muscle morphology in pediatric populations, especially children with neuromuscular diseases.

A necessary first step is identification of the most appropriate muscle group. A variety of body sites have been studied in children, the most common of which include the quadriceps, gastrocnemius, tibia, biceps, and forearm.

Muscles are studied either individually (eg, rectus femoris) or in combination with others (eg, rectus femoris and vastus intermedius) in single or various limbs.

Using a variety of muscle groups allowed for a more comprehensive assessment of whole-body nutrition assessment of children, which required ultrasound measurement of both fat and muscle layer thickness (MLT) at 9 sites, including anterior and posterior upper and lower limbs, as well as subscapular and abdominal areas. Equations using these measurements produced fat and muscle mass estimations comparable to that measured using more sophisticated imaging methods such as MRI and dual-energy x-ray absorptiometry (DXA). However, as whole-body ultrasound measurements may require a significant amount of time, some longitudinal studies have used single limbs for ultrasound measurements. In children with cancer in whom reduced lean body mass could negatively affect disease outcomes, monthly ultrasound demonstrated changes in quadriceps thickness throughout the course of cancer therapy. This suggests that, unlike in the diagnosis of neuromuscular disease, a single muscle group may be sufficient to monitor changes in body composition over time in certain groups of pediatric patients.

Both upper and lower body muscle wasting has been reported in critically ill children,and some adult data suggest that muscle wasting affects lower limbs more than upper limbs.

The quadriceps alone has also been used to monitor muscle changes in critically ill adults. Measurements of the thickness of the rectus femoris, vastus intermedius, and vastus lateralis and cross-sectional area (CSA) of the rectus femoris on alternate days demonstrate an overall decreasing trend in the first 10 days of critical illness.The quadriceps is the most commonly studied lower limb muscle in children.

Loss of muscle mass is associated with poor clinical outcomes. Patients who develop muscle wasting have higher risk of intensive care unit (ICU) acquired weakness , increased length of ICU stay and loss of muscle mass during the frst week of ICU stay is associated with increased mortality risk . Weakness and fatigue are persisting symptoms which have a negative impact on the quality of life of critical illness survivors.

Thus muscle ultrasound may add benefit in early detection of undernutrition in practice ,so this study will be conducted to explore the accuracy of muscle ultrasound in detection of undernutrition in PICU in comparison to the traditional nutritional assessment tools and to explore its impact on prognosis of such cases.

Being tested
Skeletal Muscle Ultrasonography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Skeletal Muscle UltrasonographyDiagnostic test

    Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools .

    skeletal muscle ultrasonography every 3 days.

    Measured: one year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Apr 2024
  2. Study startMar 2025 (estimated)
  3. Primary completionMar 2026 (estimated)
  4. Study completionMar 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Cross-sectional
Enrolment
50 participants (estimated)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT06382766
Sponsor's protocol ID
SMU in malnutrition
Status last verified
Apr 2024
First submitted
18 Feb 2024
Last updated
24 Apr 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Garcia GH, Fu MC, Dines DM, Craig EV, Gulotta LV. Malnutrition: a marker for increased complications, mortality, and length of stay after total shoulder arthroplasty. J Shoulder Elbow Surg. 2016 Feb;25(2):193-200. doi: 10.1016/j.jse.2015.07.034. Epub 2015 Oct 9.

    PubMed 26456427
  • Mehta NM, Duggan CP. Nutritional deficiencies during critical illness. Pediatr Clin North Am. 2009 Oct;56(5):1143-60. doi: 10.1016/j.pcl.2009.06.007.

    PubMed 19931068
  • Abera EG, Sime H. The prevalence of malnutrition among critically ill children: a systematic review and meta-analysis. BMC Pediatr. 2023 Nov 21;23(1):583. doi: 10.1186/s12887-023-04419-x.

    PubMed 37986053
  • Kasaye HK, Bobo FT, Yilma MT, Woldie M. Poor nutrition for under-five children from poor households in Ethiopia: Evidence from 2016 Demographic and Health Survey. PLoS One. 2019 Dec 20;14(12):e0225996. doi: 10.1371/journal.pone.0225996. eCollection 2019.

    PubMed 31860689
  • Ngassa AB, Meriki HD, Mbanga CM, Nzefa LD, Mbhenyane X, Tambe AB. Key predictors of undernutrition among children 6-59 months in the Buea Health District of the Southwest region of Cameroon: a cross sectional community-based survey. BMC Nutr. 2022 Dec 13;8(1):148. doi: 10.1186/s40795-022-00646-0.

    PubMed 36514089

Questions about this trial

What is this clinical trial studying?

An observational study of Skeletal Muscle Ultrasonography, run by Assiut University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Ali Hussin Mohamed, assisstant lecturer (00201064320946, Alihussin@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

accuracy of Skeletal Muscle Ultrasonography in Detection of Malnutrition and Prediction of The Outcome among critically ill children comared with other traditional nutritional assessment tools . (time frame: one year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06382766, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2024; AzTrials last refreshed its copy on 8 Nov 2026.

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