Congenital Anomalies and Risk Factors

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.

Study Overview

• Status: Completed
• Conditions: Congenital Anomalies
• Intervention / Treatment: Other: full history and clinical examination

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 Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• Egypt
  • Assiut, Egypt, 71511
    • Assiut University Children Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 4 weeks (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cases; All the babies admitted to the hospital with congenital anomalies during this period were included	Other: 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).
control; newborns without congenital anomalies	Other: 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
risk factors	To determined the risk factors of congenital anomalies by a detailed perinatal, maternal and family history were obtained by interviewing questionnaire.	6months

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Amira M. Shalaby, Lecturer, Assiut University Children Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2017
• Primary Completion (Actual): May 31, 2018
• Study Completion (Actual): May 31, 2018

Study Registration Dates

• First Submitted: October 11, 2020
• First Submitted That Met QC Criteria: October 16, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 22, 2020
• Last Update Submitted That Met QC Criteria: October 16, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Congenital Abnormalities
• Other Study ID Numbers: Assiut University CH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Prevalence, types and risk factors of congenital anomalies

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No