NCT05891210

Brief Summary

Congenital heart disease (CHD) defined as anatomic malformation of the heart and great vessels which occurs during intrauterine development irrespective of the age of presentation(1) It is classified into acyanotic and cyanotic depending upon whether the patients clinically exhibit cyanosis(2) . It is the most common human developmental anomaly with a reported prevalence of between 4 to 10 per 1000 live birth (3-6). The variety and severity of clinical presentation depend on the cardiac structures involved and their functional impact (7). Previous studies have found that, although birth weight for gestational age is usually normal in patients with congenital heart disease, young children often present with impaired growth parameters (8,9) The underlying causes of this failure to thrive may be multifactorial including innate growth potential, severity of cardiac underlying disease, increased energy requirements ,decreased nutritional intake, malabsorption and poor utilization of absorbed nutrients .these factor are particularly common and sever in low and middle income countries (11) Several studies suggest that the failure to thrive is associated with poorer cognitive development, learning disabilities, and long term behavioral problems more recently Corbett et al (12) detected a significant association between the severity of growth deficiency and IQ ,whereas Raynor and Rudolf (13) found that 55% of the infants who were failing to thrive exhibited developmental delay .In addition , A study by Reif et al (14) reported that children with a history of failure to thrive were found to have more learning difficulties and evidenced developmental delay at follow up 5 years after the initial presentation(15). Achieving survival is not the only target of clinicians for these patients, appropriate growth, development and improved quality of life are also very important. The management of children with congenital heart disease require multidisciplinary approach,in which the nutritional aspect plays an important role ,an adequate caloric intake, in fact this improve the out come of these patients.(7) This study will asses the nutritional status for patients with congenital heart disease Who are admitted at assiut university hospital children and adopting a protocol for nutritional support for them.

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
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2023

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

1 year

First QC Date

May 26, 2023

Last Update Submit

May 26, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 1. Asses the nutritional status of the children with congenital heart disease

    Adopt a protocol to avoid nutritional deficiency and achieve the normal growth in children with congenital heart disease.

    Baseline

Eligibility Criteria

Age5 Weeks - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.

You may qualify if:

  • Children more than one month and till age of 18 years that present to Assiut University Hospital Units with Cyanotic and ACyanotic Congenital heart disease will be included in our study.

You may not qualify if:

  • All pediatric patients with comorbidities other than congenital heart disease will be excluded from our study as: severe sepsis, endocarditis, empyema\& autoimmune diseases\& liver cirrhosis\& children receiving immunosuppressive therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nutritional assessment in children with congenital heart disease

Study Record Dates

First Submitted

May 26, 2023

First Posted

June 6, 2023

Study Start

September 1, 2023

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

June 6, 2023

Record last verified: 2023-05