ClinicalTrials.gg
Status unknownNCT06668233Updated Oct 31, 2024

Neurologocal Symptoms in CHD

An observational study in Neurological Disorders, sponsored by Assiut University. Status unknown. Open to participants aged 3 Years to 18 Years. Per ClinicalTrials.gov, last updated 2024-10-31.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Sep 2024), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
100
Ages
3 Years to 18 Years
Sex
All
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Study summary

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

Read the 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).

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Conditions studied

  • Neurological Disorders
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In context

Nervous System Diseases

985 studies on the registry are indexed under Nervous System Diseases; 251 are open to participants now.

This study's planned enrollment of 100 is below the median of 122 across 322 observational studies indexed under Nervous System Diseases.

Browse Nervous System Diseases studies →

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
3 Years to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

Observational model
Cohort
Time perspective
Prospective
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

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

    Radiation: CT · Radiation: CT scan

Interventions

  • RadiationCT

    CT Brain

  • RadiationCT scan

    Neuroimaging in case with delayed development , focal neurological symptoms or seziures

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What researchers measure

Primary outcomes

  1. 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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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Butler SC, Sadhwani A, Rofeberg V, Cassidy AR, Singer J, Calderon J, Wypij D, Newburger JW, Rollins CK; Cardiac Neurodevelopmental Program at Boston Children's Hospital Group. Neurological features in infants with congenital heart disease. Dev Med Child Neurol. 2022 Jun;64(6):762-770. doi: 10.1111/dmcn.15128. Epub 2021 Dec 18. PubMed 34921736 ↗

Individual participant data

Plan to share: No

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Oct 2024; primary completion for Oct 2025, 12 months later.

Of 133 non-industry observational studies under Nervous System Diseases, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 121. This study's planned 12 months is below that.

Counting every sponsor, half of 148 studies reached it within 50 months; a quarter within 15 and three quarters within 121.

Nervous System Diseases covers many different conditions, not one, so the studies compared here vary widely. Read these figures as a rough guide.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 22, 2024
First posted
Oct 31, 2024
StartEst.
Oct 2024
Primary completionEst.
Oct 2025
CompletionEst.
Nov 2025
Last update
Oct 31, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 31, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06668233
Lead sponsor
Assiut University
Responsible party
Zeinab Salah Mahmoud Ahmed (doctor, Assiut University) — Principal investigator
First posted
Oct 31, 2024
Start date
Oct 2024 (estimated)
Primary completion
Oct 2025 (estimated)
Completion
Nov 2025 (estimated)
Last update
Oct 31, 2024

Study contacts

zeinab salah Mahmoud, Bachelor of medicine
Contact
zeinab97th@gmail.com
01144020179

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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