Congenital AnomaliesNCT04598503
Congenital Anomalies and Risk Factors
An observational study of Congenital Anomalies, run by Assiut University at 1 site in Egypt.
Trial summary
The aim of the study is to determine the prevalence, describe the types and risk factors of congenital anomalies among newborns admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital (AUCH). Read more about this study
- Who is it for?
- Ages Up to 4 weeksHealthy volunteers can take part
- Conditions the study is for
- Congenital Anomalies
- What is being tested?
- full history and clinical examination
- How many people
- 346 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2017to 31 May 2018
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
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 Up to 4 weeks
- All sexes
- Healthy volunteers accepted
- Child
Study population: All the babies admitted to the hospital with congenital anomalies during this period were included.
Who may be able to join
- All the babies admitted to the hospital with congenital anomalies during this period were included.
Who cannot join
- All stillbirths were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence, Types and Risk Factors of Congenital Anomalies(A Hospital Based Study)
The aim of the study is to determine the prevalence, describe the types and risk factors of congenital anomalies among newborns admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital (AUCH). It is a prospective and a case control study was performed and screening of the newborn admitted at NICU of Assiut University Children Hospital during the period of 6 months from 1-12-2017 to the end of 5-2018 the sample was 346 newborns, 173 cases and 173 control. Data were collected using a record checklist and an interviewing questionnaire. Conclusion: The prevalence of congenital anomalies was 22.97%. The most common anomalies were gastrointestinal anomalies (GIT), musculoskeletal anomalies, multiple anomalies and circulatory system anomalies. The risk factors were consanguineous marriage, positive family history, urban areas, full-term and singleton pregnancies.
Read the detailed description
The aim of the study is to determine the prevalence, describe the types and risk factors of congenital anomalies among newborns admitted to Neonatal Intensive Care Unit (NICU). Study design: This is a prospective case control study was carried out in the neonatal intensive care unit. It is a tertiary care center. The center provides multi-specialist care and serves as a major referral center for hospitals within and outside the city. The study was done during the period of 6 months from December 2017 to May 2018. Patients: All the babies admitted to the hospital with congenital anomalies during this period were included. All stillbirths were excluded from this study. The sample was 346 newborns, 173 cases and 173 control. For each case, a detailed perinatal and maternal and family history were obtained by interviewing questionnaire. Diagnosis of congenital anomalies was based on clinical evaluation of newborn babies by the neonatologist and other appropriate investigations such as radiography, ultrasonography, echocardiography and chromosomal analysis etc... Classification of anomalies is done by systems according to WHO international classification of diseases (ICD10) [10]. Data was entered into excel data sheet and appropriate statistical analysis was performed. The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753). Statistical analysis: Data were analyzed using (SPSS Statistics for Windows, Version 21.0, NY). Descriptive analysis of the whole sample; where data were expressed as mean values and standard deviations for quantitative variables, and numbers and frequencies for qualitative variables. Bivariate analysis was performed to assess associations between various independent variables and the dependent variable (presence of congenital anomalies), chi-square was used to compare the difference in distribution of frequencies among different groups and if number inside the cell was small we used Fisher's Exact Test. Independent sample T-test was used to compare the difference in means among different groups. A significant p value was considered when it less than or equal 0.05.
- Conditions
- Congenital Anomalies
- Being tested
- full history and clinical examination
- Medical subject headings
- Congenital Abnormalities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
full history and clinical examinationOther
For each case, a detailed perinatal and maternal and family history were obtained by interviewing questionnaire. Diagnosis of congenital anomalies was based on clinical evaluation of newborn babies by the neonatologist and other appropriate investigations such as radiography, ultrasonography, echocardiography and chromosomal analysis etc... Classification of anomalies is done by systems according to WHO international classification of diseases (ICD10) [10]. Data was entered into excel data sheet and appropriate statistical analysis was performed. The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753).
| Study group | Role | What they receive |
|---|---|---|
| cases | All the babies admitted to the hospital with congenital anomalies during this period were included Receives: Other: full history and clinical examination | |
| control | newborns without congenital anomalies Receives: Other: full history and clinical examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
prevalence of congenital anomalies
The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753) newborns admitted to Neonatal Intensive Care Unit (NICU)
Measured: 6months
Secondary outcomes (1)
risk factors
To determined the risk factors of congenital anomalies by a detailed perinatal, maternal and family history were obtained by interviewing questionnaire.
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2020
- Study start1 Dec 2017
- Primary completion31 May 2018
- Study completion31 May 2018
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-control
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amira Shalaby, Assiut University
- Investigators
- Amira M. Shalaby, Lecturer, Principal investigator, Assiut University Children Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04598503
- Sponsor's protocol ID
- Assiut University CH
- Status last verified
- Oct 2020
- First submitted
- 11 Oct 2020
- Last updated
- 22 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Prevalence, types and risk factors of congenital anomalies
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence, Types and Risk Factors of Congenital Anomalies(A Hospital Based Study)
- ClinicalTrials.gov ID
- NCT04598503
- Acronym / sponsor ID
- Assiut University CH
- Conditions
- Congenital Anomalies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 22 Oct 2020 (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 aim of the study is to determine the prevalence, describe the types and risk factors of congenital anomalies among newborns admitted to Neonatal Intensive Care Unit (NICU) of Assiut University Children Hospital (AUCH). It is a prospective and a case control study was performed and screening of the newborn admitted at NICU of Assiut University Children Hospital during the period of 6 months from 1-12-2017 to the end of 5-2018 the sample was 346 newborns, 173 cases and 173 control. Data were collected using a record checklist and an interviewing questionnaire. Conclusion: The prevalence of congenital anomalies was 22.97%. The most common anomalies were gastrointestinal anomalies (GIT), musculoskeletal anomalies, multiple anomalies and circulatory system anomalies. The risk factors were consanguineous marriage, positive family history, urban areas, full-term and singleton pregnancies.
Detailed description
The aim of the study is to determine the prevalence, describe the types and risk factors of congenital anomalies among newborns admitted to Neonatal Intensive Care Unit (NICU). Study design: This is a prospective case control study was carried out in the neonatal intensive care unit. It is a tertiary care center. The center provides multi-specialist care and serves as a major referral center for hospitals within and outside the city. The study was done during the period of 6 months from December 2017 to May 2018. Patients: All the babies admitted to the hospital with congenital anomalies during this period were included. All stillbirths were excluded from this study. The sample was 346 newborns, 173 cases and 173 control. For each case, a detailed perinatal and maternal and family history were obtained by interviewing questionnaire. Diagnosis of congenital anomalies was based on clinical evaluation of newborn babies by the neonatologist and other appropriate investigations such as radiography, ultrasonography, echocardiography and chromosomal analysis etc... Classification of anomalies is done by systems according to WHO international classification of diseases (ICD10) [10]. Data was entered into excel data sheet and appropriate statistical analysis was performed. The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753). Statistical analysis: Data were analyzed using (SPSS Statistics for Windows, Version 21.0, NY). Descriptive analysis of the whole sample; where data were expressed as mean values and standard deviations for quantitative variables, and numbers and frequencies for qualitative variables. Bivariate analysis was performed to assess associations between various independent variables and the dependent variable (presence of congenital anomalies), chi-square was used to compare the difference in distribution of frequencies among different groups and if number inside the cell was small we used Fisher's Exact Test. Independent sample T-test was used to compare the difference in means among different groups. A significant p value was considered when it less than or equal 0.05.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cases | – | Other: full history and clinical examinationAll the babies admitted to the hospital with congenital anomalies during this period were included |
| control | – | Other: full history and clinical examinationnewborns without congenital anomalies |
Who may qualify
- Ages
- Up to 4 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- All the babies admitted to the hospital with congenital anomalies during this period were included.
Key inclusion criteria (1 listed)
- All the babies admitted to the hospital with congenital anomalies during this period were included.
Key exclusion criteria (1 listed)
- All stillbirths were excluded from this study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| full history and clinical examinationFor each case, a detailed perinatal and maternal and family history were obtained by interviewing questionnaire. Diagnosis of congenital anomalies was based on clinical evaluation of newborn babies by the neonatologist and other appropriate investigations such as radiography, ultrasonography, echocardiography and chromosomal analysis etc... Classification of anomalies is done by systems according to WHO international classification of diseases (ICD10) [10]. Data was entered into excel data sheet and appropriate statistical analysis was performed. The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753). | Other | cases, control |
Primary outcome
prevalence of congenital anomalies
Time frame: 6months
The prevalence was calculated by dividing the number of CA during the 6 months (173) by the total number of admission during this period (753) newborns admitted to Neonatal Intensive Care Unit (NICU)
1 secondary outcome
risk factors
Time frame: 6months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Individual participant dataSharing planned: No. Prevalence, types and risk factors of congenital anomalies
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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. This study is not recruiting at the moment.
Amira M. Shalaby, Lecturer principal investigator
Assiut University Children Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Anomalies, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
prevalence of congenital anomalies (time frame: 6months). 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 22 Oct 2020.