Interventional cross-sectional study of extra-cardiac anomalies in children with congenital heart diseases in tertiary care hospital in central India [version 1; peer review: awaiting peer review]

Background Congenital heart diseases (CHDs) in neonates often present complex clinical scenarios, and the association with extra-cardiac anomalies adds a layer of intricacy to their management. This study protocol outlines a comprehensive investigation into the prevalence and clinical outcomes of extra-cardiac anomalies in neonates diagnosed with CHDs. The study addresses gaps in current knowledge regarding this specific patient population, situated in the Neonatology unit of Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India. Methods Utilizing a descriptive, interventional cross-sectional design, the study will enrol neonates meeting inclusion criteria-diagnosis of CHDs with concurrent extra-cardiac anomalies. Rigorous data collection will involve detailed clinical histories, thorough physical examinations, and the compilation of relevant investigations, including diagnostic imaging and laboratory results. The study's temporal scope spans three years, ensuring a robust representation of the neonatal population. Statistical analysis, employing chi-square tests, Fischer's tests, and independent t-tests, will explore relationships between demographic and clinical characteristics, contributing to a nuanced understanding of this complex interplay. Expected Results Anticipated outcomes of this study include a precise estimation of the prevalence of extra-cardiac anomalies in neonates with CHDs. Furthermore, insights into this specific patient cohort's clinical outcomes and management will be gained. The study aims to unravel the intricate relationship between demographic factors, clinical characteristics, and extra-cardiac anomalies in CHD patients through meticulous data analysis. These findings are poised to inform clinical practice, enhance patient care strategies, and set the stage for further research in this critical area of neonatal medicine.