Congenital Anomalies and Risk Factors

• ClinicalTrials.gov Identifier: NCT04598503
• Recruitment Status: Completed
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Sponsor: Assiut University
• Information provided by (Responsible Party): Amira Shalaby, Assiut University

Study Description

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.

Condition or disease	Intervention/treatment
Congenital Anomalies	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 Design

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 346 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Target Follow-Up Duration: 6 Months
• Official Title: Prevalence, Types and Risk Factors of Congenital Anomalies(A Hospital Based Study)
• Actual Study Start Date: December 1, 2017
• Actual Primary Completion Date: May 31, 2018
• Actual Study Completion Date: May 31, 2018

Groups and Cohorts

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).

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

1. risk factors [ Time Frame: 6months ]
   To determined the risk factors of congenital anomalies by a detailed perinatal, maternal and family history were obtained by interviewing questionnaire.

Eligibility Criteria

• Ages Eligible for Study: up to 4 Weeks (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Probability Sample

Study Population

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

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.

Contacts and Locations

Locations

Egypt

Assiut University Children Hospital

Assiut, Egypt, 71511

Sponsors and Collaborators

Assiut University

Investigators

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

More Information

• Responsible Party: Amira Shalaby, principal investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT04598503
• Other Study ID Numbers: Assiut University CH
• First Posted: October 22, 2020
• Last Update Posted: October 22, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Prevalence, types and risk factors of congenital anomalies

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Congenital Abnormalities