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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05577130
Other study ID # GPACOCPAAUCHASGHIC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date December 30, 2023

Study information

Verified date October 2022
Source Assiut University
Contact Dalia Galal Mahran, Professor
Phone 0 100 712 0821
Email daliaym2001@yahoo.com
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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).


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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date December 30, 2023
Est. primary completion date October 30, 2023
Accepts healthy volunteers No
Gender All
Age group N/A to 4 Years
Eligibility Inclusion Criteria: - Age: 0-4 years old - Male and female, - diagnosed as cardiac diseased children Exclusion Criteria: - children more than 4 years old - not genetic disorder as down syndrome This is a descriptive study.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Assiut University

References & Publications (6)

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. — View Citation

Blasquez 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. — View Citation

El-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. — View Citation

Mari 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. — View Citation

Secker 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. — View Citation

Venugopalan P, Akinbami FO. Anthropometric measurements in children with congenital heart disease. Trop Doct. 2001 Jul;31(3):186-8. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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)
through study completion, an average of 1 year.
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