Congenital Anomalies and Risk Factors

NCT04598503 | Completed

• 1 other identifier: Assiut University CH
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Congenital Anomalies

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• risk factors

  6months

Study Arms (2)

cases

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

Other: full history and clinical examination

control

newborns without congenital anomalies

Other: full history and clinical examination

Interventions

full history and clinical examination 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).

cases; control

Eligibility Criteria

• Age: Up to 4 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• All stillbirths were excluded from this study.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Children Hospital

Asyut, 71511, Egypt

Location

MeSH Terms

Conditions

Congenital Abnormalities

Interventions

Restraint, Physical

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Behavior Control; Therapeutics; Immobilization; Investigative Techniques

Study Officials

• Amira M. Shalaby, Lecturer

  Assiut University Children Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: October 11, 2020
• First Posted: October 22, 2020
• Study Start: December 1, 2017
• Primary Completion: May 31, 2018
• Study Completion: May 31, 2018
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)