Chronic Medical DiseasesNCT05801718
Growth Parameters & Body Mass Index in Children With Chronic Diseases
An observational study of Chronic Medical Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
Deviations from the normal pattern of growth may be the first clues to pathology as in many chronic diseases evaluated clinically by anthropometric measurements \& body mass index. Read more about this study
- Who is it for?
- Ages Up to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Medical Diseases
- What is being tested?
- Growth parameters & body mass index
- How many people
- 500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2023to 1 Apr 2024
- 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 Up to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: All children with chronic diseases affecting their growth parameters \& body mass index.
Who may be able to join
- Age: under 12 years old.
- Both sex .
- Patients with chronic medical diseases.
Who cannot join
- Age: over 12years old.
- Patients with acute diseases.
- Pediatric with malignancy.
- chronic patients with surgical sequelae.
Trial locations and contacts
1 site in 1 country.
mohamed a mohamed, professor contact
About this study
Deviations from the normal pattern of growth may be the first clues to pathology as in many chronic diseases evaluated clinically by anthropometric measurements \& body mass index. Growth impairment in children with chronic diseases is associated with disruption of the growth hormone (GH) and predominantly results from undernutrition, chronic inflammation and prolonged corticosteroid treatment.
Undernutrition leads to major adaptations in the endocrine system towards conserving energy, diverting substrates away from growth and reproduction, and providing alternative sources of energy for critical body homeostasis. chronic inflammatory processes exacerbate undernutrition through proinflammatory cytokines such as interleukin-1\&6 and tumor necrosis factor. These growth-regulating mechanisms are disturbed further by corticosteroids used in some chronic conditions for their anti-inflammatory and immunosuppressive properties.
Growth impairment occurs with many chronic conditions e g: Congenital heart dieases (CHD), chronic pulmonary diseases such as bronchial asthma, Gastrointestinal diseases sch as inflammatory bowel disease ,Chronic liver diseases , Chronic renal diseases, Chronic hemolytic anemia and chronic Central nervous system diseases.
- Conditions
- Chronic Medical Diseases
- Being tested
- Growth parameters & body mass index
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Growth parameters & body mass indexDiagnostic test
measuring the anthropometric measurements including: Weight, height/ length, head circumference, mid arm circumference\& skin fold thickness and measuring body mass index.
| Study group | Role | What they receive |
|---|---|---|
| chronic cardiac patients | patients with chronic cardiac diseases affecting their groth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic renal patients | patients with chronic renal diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic respiratory diseases | patients with chronic respiratory diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic metabolic diseases | patients with chronic metabolic diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic neurological diseases | patients with chronic neurological diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic haematological diseases | patients with chronic haematological diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index | |
| chronic gastro-intestinal diseases | patients with chronic gastro-intestinal diseases affecting their growth parameters \& body mass index Receives: Diagnostic Test: Growth parameters & body mass index |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight
For children less than two years of age, use a calibrated beam or a digital infant scale. Ensure the infant is not wearing any clothes and remove the diaper before measuring the weight. The weight should be measured to the nearest 0.01 kg or 0.5 ounces. For children older than 24 months, a balanced floor scale or electronic floor scale can be used.
Measured: one year
Height
For children who can stand, a stadiometer should be used. The child should stand up straight, with buttocks, shoulder blades, and heels together touching the back of the stadiometer. The feet should face outward at a 60-degree angle. If the patient has genu valgum, separate the feet enough to avoid overlapping the knees while maintaining contact between the knees. Arms should be loosely hanging at the sides with palms facing the thighs. The horizontal bar of the stadiometer should be lowered until the hair is compressed to the crown of the head. Remove any objects on the head and hair that may obstruct the bar from compressing the hair to the crown of the head. The measurement should be read to the nearest 0.1 cm or 1/8 of an inch. Repeat the measurement twice to obtain two readings within 0.2cm or 0.25 inches. The average of the two closest measurements should be recorded.
Measured: one year
Length
For infants and toddlers who cannot stand, the recumbent length should be measured. Align the infant's head against the top of the headboard of the infantometer. An assistant must straighten the infant's body and legs, ensuring the feet are parallel to the footboard. Repeat the measurement twice to obtain two readings within 0.2 cm or 0.25 inches. The average of the two closest measurements should be recorded.
Measured: one year
Head circumference
For infants and toddlers less than two years of age, measure the largest circumference of the head using a non-stretchable measuring tape around the most prominent part of the head to the middle of the forehead. The tape measure should be pulled snug around the head to compress the hair and underlying soft tissue. Repeat the measurement twice to obtain two readings within 0.2 cm or 0.25 inches. The average of the two closest measurements should be recorded.
Measured: one year
Mid arm circumference
The patient stands upright with the arm hanging freely at the side. The patient should not flex the arm muscles. Measuring tape should be placed snugly around the mid-point of the arm without compressing the skin.
Measured: one year
Skin fold thickness
Common sites for skinfold measurements include the biceps, triceps, iliac crest, thigh, calf, subscapular, abdomen, and chest. The exact technique can vary, but we will discuss one method using the triceps as an example. For the triceps skinfold, grab the skin 2 cm above the midpoint of the right upper arm with the thumb and index finger to create a skinfold. Then, place the calipers at the midpoint to obtain the measurement. Similarly, at other sites, the skinfold measurement is obtained by grabbing the skin 2 cm away from the measuring site. Despite standard measuring techniques, skinfold testing has high variability and has limited use thus far in the clinical setting.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Apr 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Medical DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Norhan Nabil Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05801718
- Sponsor's protocol ID
- Soh-Med-23-03-09MS
- Status last verified
- Mar 2023
- First submitted
- 26 Mar 2023
- Last updated
- 6 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Costello CL, Gellatly M, Daniel J, Justo RN, Weir K. Growth Restriction in Infants and Young Children with Congenital Heart Disease. Congenit Heart Dis. 2015 Sep-Oct;10(5):447-56. doi: 10.1111/chd.12231. Epub 2014 Nov 11.
PubMed 25385245Rodig NM, McDermott KC, Schneider MF, Hotchkiss HM, Yadin O, Seikaly MG, Furth SL, Warady BA. Growth in children with chronic kidney disease: a report from the Chronic Kidney Disease in Children Study. Pediatr Nephrol. 2014 Oct;29(10):1987-95. doi: 10.1007/s00467-014-2812-9. Epub 2014 Apr 12.
PubMed 24728472Amaro F, Chiarelli F. Growth and Puberty in Children with Inflammatory Bowel Diseases. Biomedicines. 2020 Oct 29;8(11):458. doi: 10.3390/biomedicines8110458.
PubMed 33138015Hauspie R, Susanne C, Alexander F. Maturational delay and temporal growth retardation in asthmatic boys. J Allergy Clin Immunol. 1977 Mar;59(3):200-6. doi: 10.1016/0091-6749(77)90150-6.
PubMed 190283
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Parameters & Body Mass Index in Children With Chronic Diseases
- ClinicalTrials.gov ID
- NCT05801718
- Acronym / sponsor ID
- Soh-Med-23-03-09MS
- Conditions
- Chronic Medical Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Apr 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 6 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Deviations from the normal pattern of growth may be the first clues to pathology as in many chronic diseases evaluated clinically by anthropometric measurements \& body mass index. Growth impairment in children with chronic diseases is associated with disruption of the growth hormone (GH) and predominantly results from undernutrition, chronic inflammation and prolonged corticosteroid treatment.
Undernutrition leads to major adaptations in the endocrine system towards conserving energy, diverting substrates away from growth and reproduction, and providing alternative sources of energy for critical body homeostasis. chronic inflammatory processes exacerbate undernutrition through proinflammatory cytokines such as interleukin-1\&6 and tumor necrosis factor. These growth-regulating mechanisms are disturbed further by corticosteroids used in some chronic conditions for their anti-inflammatory and immunosuppressive properties.
Growth impairment occurs with many chronic conditions e g: Congenital heart dieases (CHD), chronic pulmonary diseases such as bronchial asthma, Gastrointestinal diseases sch as inflammatory bowel disease ,Chronic liver diseases , Chronic renal diseases, Chronic hemolytic anemia and chronic Central nervous system diseases.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| chronic cardiac patients | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic cardiac diseases affecting their groth parameters \& body mass index |
| chronic renal patients | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic renal diseases affecting their growth parameters \& body mass index |
| chronic respiratory diseases | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic respiratory diseases affecting their growth parameters \& body mass index |
| chronic metabolic diseases | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic metabolic diseases affecting their growth parameters \& body mass index |
| chronic neurological diseases | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic neurological diseases affecting their growth parameters \& body mass index |
| chronic haematological diseases | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic haematological diseases affecting their growth parameters \& body mass index |
| chronic gastro-intestinal diseases | – | Diagnostic Test: Growth parameters & body mass indexpatients with chronic gastro-intestinal diseases affecting their growth parameters \& body mass index |
Who may qualify
- Ages
- Up to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All children with chronic diseases affecting their growth parameters \& body mass index.
Key inclusion criteria (3 listed)
- Age: under 12 years old.
- Both sex .
- Patients with chronic medical diseases.
Key exclusion criteria (4 listed)
- Age: over 12years old.
- Patients with acute diseases.
- Pediatric with malignancy.
- chronic patients with surgical sequelae.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Growth parameters & body mass indexmeasuring the anthropometric measurements including: Weight, height/ length, head circumference, mid arm circumference\& skin fold thickness and measuring body mass index. | Diagnostic test | chronic cardiac patients, chronic gastro-intestinal diseases, chronic haematological diseases, chronic metabolic diseases, chronic neurological diseases, chronic renal patients, chronic respiratory diseases |
Primary outcome
Weight
Time frame: one year
For children less than two years of age, use a calibrated beam or a digital infant scale. Ensure the infant is not wearing any clothes and remove the diaper before measuring the weight. The weight should be measured to the nearest 0.01 kg or 0.5 ounces. For children older than 24 months, a balanced floor scale or electronic floor scale can be used.
Height
Time frame: one year
For children who can stand, a stadiometer should be used. The child should stand up straight, with buttocks, shoulder blades, and heels together touching the back of the stadiometer. The feet should face outward at a 60-degree angle. If the patient has genu valgum, separate the feet enough to avoid overlapping the knees while maintaining contact between the knees. Arms should be loosely hanging at the sides with palms facing the thighs. The horizontal bar of the stadiometer should be lowered until the hair is compressed to the crown of the head. Remove any objects on the head and hair that may obstruct the bar from compressing the hair to the crown of the head. The measurement should be read to the nearest 0.1 cm or 1/8 of an inch. Repeat the measurement twice to obtain two readings within 0.2cm or 0.25 inches. The average of the two closest measurements should be recorded.
Length
Time frame: one year
For infants and toddlers who cannot stand, the recumbent length should be measured. Align the infant's head against the top of the headboard of the infantometer. An assistant must straighten the infant's body and legs, ensuring the feet are parallel to the footboard. Repeat the measurement twice to obtain two readings within 0.2 cm or 0.25 inches. The average of the two closest measurements should be recorded.
Head circumference
Time frame: one year
For infants and toddlers less than two years of age, measure the largest circumference of the head using a non-stretchable measuring tape around the most prominent part of the head to the middle of the forehead. The tape measure should be pulled snug around the head to compress the hair and underlying soft tissue. Repeat the measurement twice to obtain two readings within 0.2 cm or 0.25 inches. The average of the two closest measurements should be recorded.
Mid arm circumference
Time frame: one year
The patient stands upright with the arm hanging freely at the side. The patient should not flex the arm muscles. Measuring tape should be placed snugly around the mid-point of the arm without compressing the skin.
Skin fold thickness
Time frame: one year
Common sites for skinfold measurements include the biceps, triceps, iliac crest, thigh, calf, subscapular, abdomen, and chest. The exact technique can vary, but we will discuss one method using the triceps as an example. For the triceps skinfold, grab the skin 2 cm above the midpoint of the right upper arm with the thumb and index finger to create a skinfold. Then, place the calipers at the midpoint to obtain the measurement. Similarly, at other sites, the skinfold measurement is obtained by grabbing the skin 2 cm away from the measuring site. Despite standard measuring techniques, skinfold testing has high variability and has limited use thus far in the clinical setting.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2023.
- Background: PubMed 25385245Costello CL, Gellatly M, Daniel J, Justo RN, Weir K. Growth Restriction in Infants and Young Children with Congenital Heart Disease. Congenit Heart Dis. 2015 Sep-Oct;10(5):447-56. doi: 10.1111/chd.12231. Epub 2014 Nov 11.
- Background: PubMed 24728472Rodig NM, McDermott KC, Schneider MF, Hotchkiss HM, Yadin O, Seikaly MG, Furth SL, Warady BA. Growth in children with chronic kidney disease: a report from the Chronic Kidney Disease in Children Study. Pediatr Nephrol. 2014 Oct;29(10):1987-95. doi: 10.1007/s00467-014-2812-9. Epub 2014 Apr 12.
- Background: PubMed 33138015Amaro F, Chiarelli F. Growth and Puberty in Children with Inflammatory Bowel Diseases. Biomedicines. 2020 Oct 29;8(11):458. doi: 10.3390/biomedicines8110458.
- Background: PubMed 190283Hauspie R, Susanne C, Alexander F. Maturational delay and temporal growth retardation in asthmatic boys. J Allergy Clin Immunol. 1977 Mar;59(3):200-6. doi: 10.1016/0091-6749(77)90150-6.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mohamed a mohamed, professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Medical Diseases, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 4 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 6 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 norhan n ahmed, resident (01021556144, norhannabil@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight (time frame: one year). The study lists 6 primary outcomes in all. 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 NCT05801718, which also lists 4 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 6 Apr 2023.