Congenital AnomaliesNCT07167017
Result Of Karyotyping in Pediatric Patients With Congenital Anomalies and Developmental Delay
An observational study of Congenital Anomalies and Development Delay, run by Assiut University.
Trial summary
The goal of this observational cross-sectional study is to study the results of karyotyping analysis for children presented with congenital anomalies and developmental delay aged 1 month to 12 years, the need for further genetic tastings and identification of parents who are carrier of balanced chromosomal… Read more about this study
- Who is it for?
- Ages 1 month to 12 years
- Conditions the study is for
- Congenital Anomalies, Development Delay
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2025to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Children aged between 1 months, and 12 years presented at Assiut university hospital with congenital anomalies and developmental delay either global developmental delay or affecting one domain (cognitive, motor, speech and language or social) during the year 2025-2026.
Who may be able to join
- All patients aged between 1 month to 12 years old who are presented with morphologic congenital anomalies associated with developmental delay either global DD or isolated developmental domain (cognitive, motor, speech and language or social) who are tested for chromosomal abnormalities
Who cannot join
- Any patient aged between 1 month and 12 years old who is presented with Developmental Delay and congenital anomalies who didn't undergo karyotyping or other genetic testing.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Result Of Karyotyping in Pediatric Patients With Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
The goal of this observational cross-sectional study is to study the results of karyotyping analysis for children presented with congenital anomalies and developmental delay aged 1 month to 12 years, the need for further genetic tastings and identification of parents who are carrier of balanced chromosomal translocations. The main question it aims to answer:
What the is the incidence of congenital anomalies tested by karyotyping and the type of chromosomal abnormalities causing the clinical features.
Read more
Researcher will take detailed clinical history, physical examination and developmental assessment for children and interpret karyotyping results.
For participants data will be collected regarding:
- History will be taken including demographic data of child age, parental age, consanguinity and relevant family history and developmental history.
- Clinical examination for any fascial dysmorphism, congenital heart disease, skeletal deformities, renal anomalies or any associated features.
- Clinical assessment of developmental milestones.
- Investigations done including laboratory tests, ultrasound scan, x-rays, CT scan, echocardiography or any other investigation.
- Karyotyping results detected if aneuploidy or structural abnormality including chromosomal deletions, duplications, translocations or inversions.
- Other genetics tests done including Comparative microarray, FISH (Fluorescence in Situ Hybridization), and WES (Whole Exome Sequencing).
- If parental karyotyping for suspected translocations was done.
Read the detailed description
Chromosomal abnormalities are the leading cause of congenital anomalies with or without neurodevelopmental delay. It is increasing in incidence worldwide and occurs in 10-15% of pregnancies and contributes to 50-70% of spontaneous abortions. The genetic and congenital anomalies are higher in Sub-Saharan Africa by 20% than industrialized countries. Developmental delay (DD) is a measurable lag in achieving the age-related developmental milestones in young children. This could affect one domain (cognitive, motor, speech and language or social) or more than one domain which is global developmental delay. Global Developmental Delay affects 1-3% of children, and the prevalence of intellectual disabilities is estimated to be 18.3/1000 child and adolescent population.
There is limited data of birth prevalence of chromosomal abnormalities in the middle east and Africa. A meta-analysis of 66 articles with 52,569 congenital anomalies cases through Africa showed that the pooled proportion of chromosomal disorders among births with congenital anomalies in Africa is 8.94%, with highest prevalence in North African area than than the other African regions, compared to 12% in the USA. This may indicate underestimation due to limited resources and diagnostic tools in developing countries. This may also contribute to the fact that prevalence in the Middle East and Africa was between 20-30/1000 live births while it was 45-50/1000 live births in developed countries.
Prenatal diagnosis plays an important role in early detection of high-risk infants with congenital anomalies. Cytogenetics tests including karyotyping and Chromosomal Microarray (CMA) are effective prenatal genetic techniques to identify fetal anomalies. This leads to improvement of clinical outcome and performing appropriate genetic counselling. Unbalanced complex chromosomal arrangements (CCRs) is a rare rearrangement that involves three or more chromosomal break points, which mostly is de Novo but can be familial. Carriers of unbalanced CCRs may have Developmental delay and Congenital anomalies while carriers of the balanced type may have recurrent abortions and give birth to children with unbalanced CCRs.
The positive diagnostic yield of G-banded karyotyping with its inability to detect chromosomal abnormalities less than 10 Mb was 7.4% after exclusion of Down Syndrome detection, compared CMA in detecting chromosomal abnormalities in patients with unexplained developmental delay, Autistic spectrum disorders and multiple congenital anomalies which is 15-20%. This due to the high resolution of CMA and ability to detect smaller chromosomal aberrations. There was a high association between presence of hypotonia and diagnostic karyotyping (p.value=<0.001) (8), so despite the superiority of CMA in detecting small deletions and duplications it is recommended to reserve karyotyping for patients with obvious chromosomal syndromes (e.g., Down syndrome), a family history of chromosomal rearrangement, or a history of multiple miscarriages.
Another evidence which leads to recommendation to make CMA is first tier test for with developmental delay, intellectual disability, autism spectrum disorder, and/or multiple congenital anomalies, that the prevalence of congenital anomalies caused by microdeletions and duplications is about 1.2% compared to 0.2% caused by trisomies (21,13,18). CMA is cost-effective in diagnosing Developmental delay and Congenital anomalies than karyotyping as well as when testing the parents in case of copy number variant of unknown significance, but its use is limited by its higher cost. Karyotyping remains a test with a reasonable diagnostic yield for countries with limited resources. Further genetic tests may be required to diagnose patients where karyotyping and CMA fails to detect a chromosomal abnormality or a pathologic copy number of variants. This includes whole exome sequencing (WES) and targeted gene panels for intellectual disabilities which includes 1,252 genes. Leite A, et al. found a diagnostic rate of 42,3% when using the three diagnostic methods of karyotyping, CMA and WES.
G-banded Karyotyping and molecular karyotyping (CMA) may impact the clinical outcome of the patient in many aspects, this includes reaching a diagnosis, predicting outcome and level of care and multidisciplinary team assigned for managing the affected patients. It is mandatory to establish an effective cytogenetic-diagnostic facility beside well-trained genetic counsellors. This is in addition to developing a local registry system for congenital anomalies. On the other hand, parents testing and prenatal counselling or antenatal genetic testing in cases of balanced chromosomal rearrangements carriers is mandatory towards preventing recurrence.
- Conditions
- Congenital Anomalies, Development Delay
- Keywords
- karyotyping, congenital anomalies, developmental delay
- Medical subject headings
- Congenital Abnormalities, Learning Disabilities
What is being measured
The primary outcome is the main question the study is designed to answer.
Result Of Karyotyping in Pediatric Patients with Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
To detect the incidence of congenital anomalies and developmental delay tested with karyotyping and to detect karyotyping findings of chromosomal numerical or structural abnormalities that cause clinical features.
Measured: November 2025-December 2026
Secondary outcomes (1)
Result Of Karyotyping in Pediatric Patients with Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
To determine patients requiring further testing due to inability of karyotyping in reaching a diagnosis
- Detect parents requiring karyotyping to detect carriers of balanced chromosomal translocations
Measured: November 2025-December 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study start1 Nov 2025 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital AnomaliesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manahil Saad Mohamed Elkarsani, Assiut University
- Investigators
- Mohamed Mahrous Mohamed, Professor of pediatrics, Study director, Assiut UniversityMohamed Abobakr Mohamed, Lecturer of pediatr, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07167017
- Sponsor's protocol ID
- karyotyping results
- Status last verified
- Sep 2025
- First submitted
- 3 Sep 2025
- Last updated
- 11 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Result Of Karyotyping in Pediatric Patients With Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
- ClinicalTrials.gov ID
- NCT07167017
- Acronym / sponsor ID
- karyotyping results
- Conditions
- Congenital Anomalies, Development Delay
- Keywords
- karyotyping, congenital anomalies, developmental delay
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this observational cross-sectional study is to study the results of karyotyping analysis for children presented with congenital anomalies and developmental delay aged 1 month to 12 years, the need for further genetic tastings and identification of parents who are carrier of balanced chromosomal translocations. The main question it aims to answer:
What the is the incidence of congenital anomalies tested by karyotyping and the type of chromosomal abnormalities causing the clinical features.
Researcher will take detailed clinical history, physical examination and developmental assessment for children and interpret karyotyping results.
For participants data will be collected regarding:
- History will be taken including demographic data of child age, parental age, consanguinity and relevant family history and developmental history.
- Clinical examination for any fascial dysmorphism, congenital heart disease, skeletal deformities, renal anomalies or any associated features.
- Clinical assessment of developmental milestones.
- Investigations done including laboratory tests, ultrasound scan, x-rays, CT scan, echocardiography or any other investigation.
- Karyotyping results detected if aneuploidy or structural abnormality including chromosomal deletions, duplications, translocations or inversions.
- Other genetics tests done including Comparative microarray, FISH (Fluorescence in Situ Hybridization), and WES (Whole Exome Sequencing).
- If parental karyotyping for suspected translocations was done.
Detailed description
Chromosomal abnormalities are the leading cause of congenital anomalies with or without neurodevelopmental delay. It is increasing in incidence worldwide and occurs in 10-15% of pregnancies and contributes to 50-70% of spontaneous abortions. The genetic and congenital anomalies are higher in Sub-Saharan Africa by 20% than industrialized countries. Developmental delay (DD) is a measurable lag in achieving the age-related developmental milestones in young children. This could affect one domain (cognitive, motor, speech and language or social) or more than one domain which is global developmental delay. Global Developmental Delay affects 1-3% of children, and the prevalence of intellectual disabilities is estimated to be 18.3/1000 child and adolescent population.
There is limited data of birth prevalence of chromosomal abnormalities in the middle east and Africa. A meta-analysis of 66 articles with 52,569 congenital anomalies cases through Africa showed that the pooled proportion of chromosomal disorders among births with congenital anomalies in Africa is 8.94%, with highest prevalence in North African area than than the other African regions, compared to 12% in the USA. This may indicate underestimation due to limited resources and diagnostic tools in developing countries. This may also contribute to the fact that prevalence in the Middle East and Africa was between 20-30/1000 live births while it was 45-50/1000 live births in developed countries.
Prenatal diagnosis plays an important role in early detection of high-risk infants with congenital anomalies. Cytogenetics tests including karyotyping and Chromosomal Microarray (CMA) are effective prenatal genetic techniques to identify fetal anomalies. This leads to improvement of clinical outcome and performing appropriate genetic counselling. Unbalanced complex chromosomal arrangements (CCRs) is a rare rearrangement that involves three or more chromosomal break points, which mostly is de Novo but can be familial. Carriers of unbalanced CCRs may have Developmental delay and Congenital anomalies while carriers of the balanced type may have recurrent abortions and give birth to children with unbalanced CCRs.
The positive diagnostic yield of G-banded karyotyping with its inability to detect chromosomal abnormalities less than 10 Mb was 7.4% after exclusion of Down Syndrome detection, compared CMA in detecting chromosomal abnormalities in patients with unexplained developmental delay, Autistic spectrum disorders and multiple congenital anomalies which is 15-20%. This due to the high resolution of CMA and ability to detect smaller chromosomal aberrations. There was a high association between presence of hypotonia and diagnostic karyotyping (p.value=<0.001) (8), so despite the superiority of CMA in detecting small deletions and duplications it is recommended to reserve karyotyping for patients with obvious chromosomal syndromes (e.g., Down syndrome), a family history of chromosomal rearrangement, or a history of multiple miscarriages.
Another evidence which leads to recommendation to make CMA is first tier test for with developmental delay, intellectual disability, autism spectrum disorder, and/or multiple congenital anomalies, that the prevalence of congenital anomalies caused by microdeletions and duplications is about 1.2% compared to 0.2% caused by trisomies (21,13,18). CMA is cost-effective in diagnosing Developmental delay and Congenital anomalies than karyotyping as well as when testing the parents in case of copy number variant of unknown significance, but its use is limited by its higher cost. Karyotyping remains a test with a reasonable diagnostic yield for countries with limited resources. Further genetic tests may be required to diagnose patients where karyotyping and CMA fails to detect a chromosomal abnormality or a pathologic copy number of variants. This includes whole exome sequencing (WES) and targeted gene panels for intellectual disabilities which includes 1,252 genes. Leite A, et al. found a diagnostic rate of 42,3% when using the three diagnostic methods of karyotyping, CMA and WES.
G-banded Karyotyping and molecular karyotyping (CMA) may impact the clinical outcome of the patient in many aspects, this includes reaching a diagnosis, predicting outcome and level of care and multidisciplinary team assigned for managing the affected patients. It is mandatory to establish an effective cytogenetic-diagnostic facility beside well-trained genetic counsellors. This is in addition to developing a local registry system for congenital anomalies. On the other hand, parents testing and prenatal counselling or antenatal genetic testing in cases of balanced chromosomal rearrangements carriers is mandatory towards preventing recurrence.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged between 1 months, and 12 years presented at Assiut university hospital with congenital anomalies and developmental delay either global developmental delay or affecting one domain (cognitive, motor, speech and language or social) during the year 2025-2026.
Key inclusion criteria (1 listed)
- All patients aged between 1 month to 12 years old who are presented with morphologic congenital anomalies associated with developmental delay either global DD or isolated developmental domain (cognitive, motor, speech and language or social) who are tested for chromosomal abnormalities
Key exclusion criteria (1 listed)
- Any patient aged between 1 month and 12 years old who is presented with Developmental Delay and congenital anomalies who didn't undergo karyotyping or other genetic testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Result Of Karyotyping in Pediatric Patients with Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
Time frame: November 2025-December 2026
To detect the incidence of congenital anomalies and developmental delay tested with karyotyping and to detect karyotyping findings of chromosomal numerical or structural abnormalities that cause clinical features.
1 secondary outcome
Result Of Karyotyping in Pediatric Patients with Congenital Anomalies and Developmental Delay at Assiut University Children Hospital
Time frame: November 2025-December 2026
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
Related trials for Congenital Anomalies
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
RecruitingPhase 1/2
A First-in-human Study of KK8123 in Adults With X-linked Hypophosphatemia
X-linked Hypophosphatemia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mohamed Mahrous Mohamed, Professor of pediatrics study director
Assiut University
Mohamed Abobakr Mohamed, Lecturer of pediatr study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomalies and Development Delay, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Manahil Dr. (00201107189787, manahilelkarsani773@med.aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Result Of Karyotyping in Pediatric Patients with Congenital Anomalies and Developmental Delay at Assiut University Children Hospital (time frame: November 2025-December 2026). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.