Growth DisordersNCT05577130
Growth Pattern and Characteristics of Cardiac Pediatric Patients
An observational study of Growth Disorders, run by Assiut University.
Trial summary
Congenital heart disease (CHD) is the most common congenital anomaly in the body, affecting about 8 per 1000children. cardiovascular disorders are the most debilitating and one of causes of organic growth disorders in children.Malnutrition is a constant phenomenon among children with CHD. Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Growth Disorders
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2022to 30 Dec 2023
- 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 4 years
- All sexes
- No healthy volunteers
- Child
Study population: Age: 0-4 years old * Male and female * diagnosed as cardiac patient * children are not more than 4 years old. * Not genetic disorder as down syndrome
Who may be able to join
- Age: 0-4 years old
- Male and female,
- diagnosed as cardiac diseased children
Who cannot join
- children more than 4 years old
- not genetic disorder as down syndrome This is a descriptive study.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Growth Pattern and Characteristics of Cardiac Pediatric Patients Attending Assiut University Children Hospital and Sidi Galal Health Insurance Clinic
Congenital heart disease (CHD) is the most common congenital anomaly in the body, affecting about 8 per 1000children. cardiovascular disorders are the most debilitating and one of causes of organic growth disorders in children.Malnutrition is a constant phenomenon among children with CHD. The degree and type of malnutrition may be related to characteristics of the CHD, including presence of cyanosis, congestive heart failure (CHF), or pulmonary hypertension (PHTN).
Read the detailed description
At birth, the weight and length of children with CHD are close to normal and APGAR scores are generally high. Cyanotic patients are affected in growth, depending on the severity of tissue hypoxemia and on the degree of physiological variation. Mostly acute malnutrition occurs in a cyanotic heart disease but chronic malnutrition occurs in cyanotic lesions. The severity of malnutrition variety from mild under nutrition to failure to thrive. impairing growth and increasing post-operative morbidity and mortality. Early rapid growth retardation detection in early age and improved nutritional status have the potential to reduce cardiac impact on growth and feeding. Insure appropriate nutrition in those patients by the two main methods (enteral and parenteral) help in better outcome
- Conditions
- Growth Disorders
- Medical subject headings
- Growth Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Study the pattern of growth in infant and children with heart diseases.
By measurement of :
- Weight in (Kg)and height in (m) will be combined to report BMI in kg/m^2).
- Measure mid arm circumference in (cm) \& head circumference in(cm)
Measured: through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start1 Nov 2022 (estimated)
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Growth DisordersStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Other
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Safaa Ahmed Mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577130
- Sponsor's protocol ID
- GPACOCPAAUCHASGHIC
- Status last verified
- Oct 2022
- First submitted
- 16 Sep 2021
- Last updated
- 13 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Arodiwe I, Chinawa J, Ujunwa F, Adiele D, Ukoha M, Obidike E. Nutritional status of congenital heart disease (CHD) patients: Burden and determinant of malnutrition at university of Nigeria teaching hospital Ituku - Ozalla, Enugu. Pak J Med Sci. 2015 Sep-Oct;31(5):1140-5. doi: 10.12669/pjms.315.6837.
PubMed 26649002Mari MA, Cascudo MM, Alchieri JC. Congenital Heart Disease and Impacts on Child Development. Braz J Cardiovasc Surg. 2016 Feb;31(1):31-7. doi: 10.5935/1678-9741.20160001.
PubMed 27074272El-Koofy N, Mahmoud AM, Fattouh AM. Nutritional rehabilitation for children with congenital heart disease with left to right shunt. Turk J Pediatr. 2017;59(4):442-451. doi: 10.24953/turkjped.2017.04.011.
PubMed 29624225Venugopalan P, Akinbami FO. Anthropometric measurements in children with congenital heart disease. Trop Doct. 2001 Jul;31(3):186-8. doi: 10.1177/004947550103100333. No abstract available.
PubMed 11444357Blasquez A, Clouzeau H, Fayon M, Mouton JB, Thambo JB, Enaud R, Lamireau T. Evaluation of nutritional status and support in children with congenital heart disease. Eur J Clin Nutr. 2016 Apr;70(4):528-31. doi: 10.1038/ejcn.2015.209. Epub 2015 Dec 23.
PubMed 26695725Secker DJ, Jeejeebhoy KN. How to perform Subjective Global Nutritional assessment in children. J Acad Nutr Diet. 2012 Mar;112(3):424-431.e6. doi: 10.1016/j.jada.2011.08.039. Epub 2012 Mar 1.
PubMed 22717202
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Growth Pattern and Characteristics of Cardiac Pediatric Patients Attending Assiut University Children Hospital and Sidi Galal Health Insurance Clinic
- ClinicalTrials.gov ID
- NCT05577130
- Acronym / sponsor ID
- GPACOCPAAUCHASGHIC
- Conditions
- Growth Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2022 (estimated)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 13 Oct 2022 (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.
Congenital heart disease (CHD) is the most common congenital anomaly in the body, affecting about 8 per 1000children. cardiovascular disorders are the most debilitating and one of causes of organic growth disorders in children.Malnutrition is a constant phenomenon among children with CHD. The degree and type of malnutrition may be related to characteristics of the CHD, including presence of cyanosis, congestive heart failure (CHF), or pulmonary hypertension (PHTN).
Detailed description
At birth, the weight and length of children with CHD are close to normal and APGAR scores are generally high. Cyanotic patients are affected in growth, depending on the severity of tissue hypoxemia and on the degree of physiological variation. Mostly acute malnutrition occurs in a cyanotic heart disease but chronic malnutrition occurs in cyanotic lesions. The severity of malnutrition variety from mild under nutrition to failure to thrive. impairing growth and increasing post-operative morbidity and mortality. Early rapid growth retardation detection in early age and improved nutritional status have the potential to reduce cardiac impact on growth and feeding. Insure appropriate nutrition in those patients by the two main methods (enteral and parenteral) help in better outcome
Study design
- Observational model
- Case only
- Time perspective
- Other
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Age: 0-4 years old * Male and female * diagnosed as cardiac patient * children are not more than 4 years old. * Not genetic disorder as down syndrome
Key inclusion criteria (3 listed)
- Age: 0-4 years old
- Male and female,
- diagnosed as cardiac diseased children
Key exclusion criteria (2 listed)
- children more than 4 years old
- not genetic disorder as down syndrome This is a descriptive study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Study the pattern of growth in infant and children with heart diseases.
Time frame: through study completion, an average of 1 year.
By measurement of : * Weight in (Kg)and height in (m) will be combined to report BMI in kg/m^2). * Measure mid arm circumference in (cm) \& head circumference in(cm)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2022.
- Background: PubMed 26649002Arodiwe I, Chinawa J, Ujunwa F, Adiele D, Ukoha M, Obidike E. Nutritional status of congenital heart disease (CHD) patients: Burden and determinant of malnutrition at university of Nigeria teaching hospital Ituku - Ozalla, Enugu. Pak J Med Sci. 2015 Sep-Oct;31(5):1140-5. doi: 10.12669/pjms.315.6837.
- Background: PubMed 27074272Mari MA, Cascudo MM, Alchieri JC. Congenital Heart Disease and Impacts on Child Development. Braz J Cardiovasc Surg. 2016 Feb;31(1):31-7. doi: 10.5935/1678-9741.20160001.
- Background: PubMed 29624225El-Koofy N, Mahmoud AM, Fattouh AM. Nutritional rehabilitation for children with congenital heart disease with left to right shunt. Turk J Pediatr. 2017;59(4):442-451. doi: 10.24953/turkjped.2017.04.011.
- Background: PubMed 11444357Venugopalan P, Akinbami FO. Anthropometric measurements in children with congenital heart disease. Trop Doct. 2001 Jul;31(3):186-8. doi: 10.1177/004947550103100333. No abstract available.
- Background: PubMed 26695725Blasquez A, Clouzeau H, Fayon M, Mouton JB, Thambo JB, Enaud R, Lamireau T. Evaluation of nutritional status and support in children with congenital heart disease. Eur J Clin Nutr. 2016 Apr;70(4):528-31. doi: 10.1038/ejcn.2015.209. Epub 2015 Dec 23.
- Background: PubMed 22717202Secker DJ, Jeejeebhoy KN. How to perform Subjective Global Nutritional assessment in children. J Acad Nutr Diet. 2012 Mar;112(3):424-431.e6. doi: 10.1016/j.jada.2011.08.039. Epub 2012 Mar 1.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Growth Disorders, 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 3 inclusion and 2 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 13 Oct 2022. 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 Dalia Galal Mahran, Professor (0 100 712 0821, daliaym2001@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Study the pattern of growth in infant and children with heart diseases. (time frame: through study completion, an average of 1 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 NCT05577130, which also lists 6 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 13 Oct 2022.