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Clinical Trials/NCT06668233
NCT06668233
Not Yet Recruiting
N/A

Neurocognitive Disorders in Children with Congenital Heart Disease

Assiut University0 sites100 target enrollmentOctober 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Neurological Disorders
Sponsor
Assiut University
Enrollment
100
Primary Endpoint
The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment.
Status
Not Yet Recruiting
Last Updated
last year

Overview

Brief Summary

The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment

Detailed Description

Congenital heart defects are significant structural abnormalities affecting the heart and major intrathoracic vessels. They are among the most common birth defects, constituting about one-third of all major congenital anomalies. Many of these defects necessitate surgical intervention during early childhood. Advances in surgical techniques have significantly improved survival rates for patients with congenital heart disease (CHD). However, a variety of systemic complications have become more apparent, including issues affecting the cardiac, pulmonary, gastrointestinal, neurological, and nephrological systems (Walaa El Naga et al., 2022). Neurological complications greatly contribute to morbidity and mortality in pediatric CHD patients, significantly impacting their neurodevelopmental outcomes. Various studies indicate that up to 30% of children with congenital heart disease (CHD) experience neurological complications. Seizures are the most frequently reported neurological complication, accounting for approximately 70% of cases with neurological sequelae (Aly El Kazaz et al., 2022). Also Neuropsychological studies of children with complex CHD reveal distinct deficits in intelligence, cognitive performance, executive function, language skills, visuospatial abilities, and attention. (Guo et al., 2021). Recognizing the long-term consequences of accumulated brain injury underscores the importance of identifying and minimizing early insults. (Le H.Sterling et al., 2021) The recognized neurodevelopmental challenges faced by children with CHD prompted the American Heart Association to recommend routine neurodevelopmental evaluations for high-risk patients with CHD. According to the American Heart Association, the initial visit, conducted before 12 months of age, should include a neuromotor examination assessing muscle tone, primitive and deep tendon reflexes, sensory status, and gross motor skills. Although many children with CHD now undergo these recommended neurological examinations, the examinations and their outcomes have not been thoroughly described. Additionally, factors predicting abnormal neurological examination results have not been identified. Enhancing our understanding of the findings from these routinely recommended evaluations will improve the detection of abnormalities, thereby optimizing support for children with CHD and their families.(Le Samantha butler et al., 2023).

Registry
clinicaltrials.gov
Start Date
October 2024
End Date
November 2025
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Zeinab Salah Mahmoud Ahmed

doctor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • Children from 3 years to 18 years with congenital heart disease

Exclusion Criteria

  • New born infants. Children with normal heart. Children with chromosomal or metabolic disease.

Outcomes

Primary Outcomes

The aim of the study is to determine neurological and cognitive disorders in children with congenital heart disease for early diagnosis and treatment.

Time Frame: one year

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