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Developing and validating a neonatal screening tool for congenital anomalies to be used in low- and middle-income
Hana Abebe Gebreselassie1, Kokila Lakhoo2
1Department of Surgery, St Paul's Hospital Millennium Medical College, Addis Ababa, Ethiopia hanaabebe23@gmail.com.
Insights
A new, low-cost newborn screening tool for congenital anomalies was developed and validated. This tool shows high sensitivity and specificity, making it suitable for resource-limited settings to improve infant health outcomes.
Area of Science:
- Pediatrics
- Public Health
- Medical Diagnostics
Background:
- Congenital anomalies are a significant cause of infant mortality in low- and middle-income countries.
- Limited newborn screening programs in resource-limited settings lead to undiagnosed anomalies and adverse outcomes.
- Early detection and intervention are crucial for improving infant health.
Purpose of the Study:
- To develop a novel newborn screening tool for congenital anomalies.
- To validate the screening tool for effectiveness in resource-limited settings.
- To address the gap in newborn screening access in underserved regions.
Main Methods:
- A Delphi approach was employed to convene experts and formulate the screening tool.
- The tool was validated through application to 1160 neonates at St. Paul's Hospital Millennium Medical College.
- Data analysis involved descriptive statistics and calculation of sensitivity and specificity using SPSS V.26.
Main Results:
- The prevalence of congenital anomalies was found to be 5.7%, with the central nervous system being the most affected.
- The screening tool demonstrated high validity with 86.4% sensitivity and 97.8% specificity.
- Positive and negative predictive values were 70.4% and 99.2%, respectively, indicating strong performance.
Conclusions:
- Congenital anomalies are prevalent, necessitating effective screening methods.
- The developed neonatal screening tool is validated, cost-effective, and easily implementable.
- This tool offers a promising solution for improving congenital anomaly detection in resource-limited environments.
Background:
Congenital anomalies are among the common health problems faced by children in low- and middle-income countries, contributing substantially to infant mortality rates. Due to limited access to newborn screening programmes in most of the resource-limited settings, many congenital anomalies go undiagnosed and untreated, leading to adverse outcomes. This study aimed to develop and validate a newborn screening tool for congenital anomalies for use in resource-limited settings.
Methods:
A Delphi approach was used to assemble a group of experts and develop the screening tool. Tool validation was done by applying it to a reasonable number of neonates who were delivered and/or admitted to the neonatal intensive care unit of St. Paul's Hospital Millennium Medical College. Data were collected using Kobo Collect and then exported to Microsoft Excel and SPSS V.26 for analysis. Frequencies, percentages, mean and SD were used to describe categorical results. The sensitivity and specificity of the screening tool were calculated to assess its validity.
Results:
A total of 1160 neonates were screened for congenital anomalies, of which 673 (58%) were male. The mean age of the newborns was 26.9±33 hours. Term newborns accounted for 898 (77.4%) of the study population. The prevalence of congenital anomalies in our series was 5.7%, with the most involved body systems being the central nervous system (33.7%), genitourinary (18.5%), gastrointestinal (11%) and musculoskeletal (11%). More than one anomaly was diagnosed in 11 (13.6%) neonates. The sensitivity and specificity of this tool were 86.4% and 97.8%, respectively. Furthermore, the positive and negative predictive values of the screening tool were 70.4% and 99.2%, respectively.
Conclusion:
Congenital anomalies are not rare findings in our hospital. The neonatal screening tool, which was developed through this study, has commendable validity results in addition to being low-cost and easily implementable.
