Congenital Anomalies and Risk Factors

NCT ID: NCT04598503

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-12-01
• Study Completion Date: 2018-05-31

Brief 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). 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.

Conditions

Congenital Anomalies

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

cases

All the babies admitted to the hospital with congenital anomalies during this period were included

full history and clinical examination

Intervention Type: OTHER

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).

control

newborns without congenital anomalies

full history and clinical examination

Intervention Type: OTHER

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).

Interventions

full history and clinical examination

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• All the babies admitted to the hospital with congenital anomalies during this period were included.

Exclusion Criteria

• All stillbirths were excluded from this study.

• Maximum Eligible Age: 4 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Amira Shalaby

principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amira M. Shalaby, Lecturer

Role: PRINCIPAL_INVESTIGATOR

Assiut University Children Hospital

Locations

Assiut University Children Hospital

Asyut, , Egypt

Countries

Egypt

Other Identifiers

Assiut University CH

Identifier Type: -

Identifier Source: org_study_id