NCT05577130

Brief 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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2021

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 13, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

November 1, 2022

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2023

Completed
Last Updated

October 13, 2022

Status Verified

October 1, 2022

Enrollment Period

12 months

First QC Date

September 16, 2021

Last Update Submit

October 9, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodProbability Sample
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

You may qualify if:

  • Age: 0-4 years old
  • Male and female,
  • diagnosed as cardiac diseased children

You may not qualify if:

  • children more than 4 years old
  • not genetic disorder as down syndrome This is a descriptive study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 26649002BACKGROUND
  • 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.

    PMID: 27074272BACKGROUND
  • 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.

    PMID: 29624225BACKGROUND
  • Venugopalan 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.

    PMID: 11444357BACKGROUND
  • 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.

    PMID: 26695725BACKGROUND
  • 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.

    PMID: 22717202BACKGROUND

MeSH Terms

Conditions

Growth Disorders

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Dalia Galal Mahran, Professor

CONTACT

Duaa Mohamed Rafaat, Assistant

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor in family medicine

Study Record Dates

First Submitted

September 16, 2021

First Posted

October 13, 2022

Study Start

November 1, 2022

Primary Completion

October 30, 2023

Study Completion

December 30, 2023

Last Updated

October 13, 2022

Record last verified: 2022-10