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Study Protocol

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: 1 approved with reservations]
Rahul Y Khandelwal
https://orcid.org/0009-0002-3290-0014
1, Jayant Vagha1
Rahul Y Khandelwal
https://orcid.org/0009-0002-3290-0014
1, Jayant Vagha1
PUBLISHED 23 Apr 2024
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OPEN PEER REVIEW
REVIEWER STATUS

This article is included in the Datta Meghe Institute of Higher Education and Research collection.

Abstract

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.

Keywords

Congenital Heart Diseases, Neonates, Extra-cardiac Anomalies, Tertiary Care Hospital, Cross-sectional Study, Clinical Outcomes

Corresponding author: Rahul Y Khandelwal
Competing interests: No competing interests were disclosed.
Grant information: The author(s) declared that no grants were involved in supporting this work.
Copyright:  © 2024 Khandelwal RY and Vagha J. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
How to cite: Khandelwal RY and Vagha J. 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: 1 approved with reservations]. F1000Research 2024, 13:345 (https://doi.org/10.12688/f1000research.144932.1) First published: 23 Apr 2024, 13:345 (https://doi.org/10.12688/f1000research.144932.1) Latest published: 23 Apr 2024, 13:345 (https://doi.org/10.12688/f1000research.144932.1)

Introduction

Congenital heart diseases (CHDs) constitute a significant burden of morbidity and mortality among neonates globally, posing multifaceted challenges to healthcare systems.1 While advancements in medical science have improved diagnostics and interventions, the coexistence of extra-cardiac anomalies in neonates with CHDs introduces additional layers of complexity to their clinical management.2 This study protocol outlines a comprehensive investigation into the prevalence and clinical outcomes of extra-cardiac anomalies in neonates diagnosed with CHDs within a tertiary care hospital in Central India.

Globally, CHDs are recognised as the most prevalent group of congenital anomalies, affecting approximately 8 in 1,000 live births.3 These anomalies often necessitate intricate medical interventions, making CHDs a leading cause of neonatal morbidity and mortality.4 The simultaneous presence of extra-cardiac anomalies further compounds the challenges faced by clinicians in providing effective and tailored care.

The prevalence of CHDs varies across populations, and recent evidence suggests that the presence of extra-cardiac anomalies might influence both the clinical course and outcomes of neonates with CHDs.5 Despite advancements in medical research, there is a paucity of population-specific data on the association between CHDs and extra-cardiac anomalies in the Central Indian context. Understanding the nuanced relationship between these anomalies is crucial for optimising diagnostic strategies, clinical management, and resource allocation.

Aim

The primary aim of this interventional cross-sectional study is to investigate the association between extra-cardiac anomalies and congenital heart diseases (CHDs) in neonates within a tertiary care hospital in Central India.

Objectives

  • 1. To estimate the prevalence of extra-cardiac anomalies in neonates diagnosed with congenital heart diseases.

  • 2. To evaluate and compare the clinical outcomes of neonates with CHDs who have additional extra-cardiac anomalies against those without such anomalies.

  • 3. To explore the relationship between demographic factors (e.g., gestational age, birth weight) and clinical characteristics (e.g., serum electrolyte levels) with extra-cardiac anomalies in CHD patients.

  • 4. To identify and analyse potential etiological factors contributing to the co-occurrence of extra-cardiac anomalies in neonates with CHDs.

  • 5. To document the clinical course, interventions, and management strategies employed in neonates with CHDs and extra-cardiac anomalies, providing insights into the challenges and opportunities for improving patient care.

Method

Study design

This study will adopt a descriptive, interventional cross-sectional design.

Study population

The study population comprises neonates diagnosed with congenital heart diseases (CHDs) admitted to the Neonatology unit at the Department of Pediatrics, Jawaharlal Nehru Medical College & AVBR Hospital, Sawangi, Wardha, Central India.

Place of study

The study will be conducted at the Neonatology unit within the hospital. This unit encompasses the Outpatient Department (OPD), Pediatrics Ward, Pediatric Intensive Care Unit (PICU), and Neonatal Intensive Care Unit (NICU).

Inclusion criteria

Neonates meeting the following criteria will be included in the study:

  • • Diagnosis of congenital heart diseases (CHDs).

  • • Presence of extra-cardiac anomalies.

Exclusion criteria

Neonates meeting any of the following criteria will be excluded from the study:

  • • Refusal of consent from parents or guardians.

Bias

During this study, several potential biases may influence the interpretation of results. Selection bias is a concern, given that the study population is drawn from a tertiary care hospital, possibly skewing the representation towards individuals seeking specialised care. Efforts will be made to diversify the study population by including patients from various socioeconomic backgrounds, and findings will be interpreted with the acknowledgement of potential selection biases.

Information bias is another consideration, particularly in the retrospective components relying on medical records. To minimise this bias, the study team will adhere to standardised protocols for data collection, and regular training sessions will be conducted. Cross-referencing with multiple sources will be employed to validate the accuracy of the collected data.

Recall bias may affect the quality of information parents or guardians provide regarding the neonate’s medical history. To address this, the research team will use detailed and structured questionnaires, and interviews will be conducted as promptly as possible after relevant events to ensure accurate recollection.

Enrollment

Challenges related to inclusion criteria may arise, particularly when the diagnosis of congenital heart diseases (CHDs) or extra-cardiac anomalies is not straightforward. To navigate this, the study will establish clear and standardised diagnostic criteria, with consultations sought from specialists to ensure accurate inclusion. Diagnostic confirmation will be based on comprehensive reviews of medical records and expert consultations.

Refusal of consent poses a potential challenge, as excluding cases based on consent refusal may introduce bias. Those who decline participation may differ systematically from those who provide consent. Mitigation strategies include effective communication with parents or guardians, providing clear and understandable information about the study, and emphasising sensitivity to concerns and questions to encourage informed consent.

Addressing these potential biases and enrollment challenges is essential to bolster the study’s internal validity, ensuring that the findings accurately reflect the relationship between extra-cardiac anomalies and congenital heart diseases in the population under investigation.

Data collection process

Before embarking on the data collection process, the study will begin with a crucial step: obtaining informed consent from the parents or legal guardians of neonates participating. Clear explanations about the study’s purpose, procedures, potential risks, and benefits will be provided, and participants will be assured of the voluntary nature of their involvement, along with the commitment to maintaining confidentiality. The study will unfold within the Neonatology unit at the Department of Pediatrics in Jawaharlal Nehru Medical College and AVBR Hospital, Sawangi, Wardha, Central India. This unit encompasses the Outpatient Department (OPD), Pediatrics Ward, Pediatric Intensive Care Unit (PICU), and Neonatal Intensive Care Unit (NICU).

Identifying eligible participants is the next step, with neonates meeting the inclusion criteria—diagnosis of congenital heart diseases (CHDs) with accompanying extra-cardiac anomalies—being selected during their visits to the various units mentioned earlier. To ensure a systematic approach to data collection, a pre-designed and pre-validated proforma will serve as the primary tool. This comprehensive document covers demographic details, medical history, clinical examination findings, diagnostic results, and specifics about interventions and management.

Collecting pertinent information begins with a detailed clinical history, drawing on perinatal, family, and prenatal aspects. This data will be sourced from medical records and interviews with parents or guardians. Trained healthcare professionals will conduct a meticulous physical examination focusing on cardiac and extra-cardiac anomalies. In addition to clinical history and examination, relevant investigations such as diagnostic imaging, echocardiograms, and laboratory results (including serum electrolytes) will be meticulously recorded from the patient’s medical records.

Throughout their stay in the Neonatology unit, the clinical course of each neonate will be closely documented. This includes any complications encountered, treatments administered, and interventions employed. Once the necessary information has been gathered, a crucial step involves entering the data into a Microsoft Excel spreadsheet. This task will be performed by trained research personnel, ensuring accuracy and consistency in the recorded data.

To maintain the quality and integrity of the data, regular checks for accuracy and completeness will be implemented as part of a robust quality control process. Any discrepancies or missing information will be promptly addressed by verifying the source documents. The study will progress to the statistical analysis stage after the data collection phase. This analysis, guided by the study protocol, will explore relationships between demographic and clinical characteristics, shedding light on the nuanced association between extra-cardiac anomalies and congenital heart diseases in neonates within the hospital setting.

Expected outcome

  • 1. Prevalence estimation: The investigation seeks to provide a precise estimate of the prevalence of extra-cardiac anomalies among neonates diagnosed with CHDs in the specified population. This information is crucial for healthcare planning and resource allocation.

  • 2. Clinical outcomes: By evaluating the clinical course, morbidity, and mortality of neonates with both CHDs and extra-cardiac anomalies, the study aims to uncover patterns and associations that may influence patient outcomes. This knowledge can guide clinicians in tailoring interventions for this specific patient population.

  • 3. Demographic and etiological factors: The study will explore the influence of demographic factors such as gestational age and birth weight on the occurrence of extra-cardiac anomalies in CHD patients. Additionally, it will investigate potential etiological factors contributing to the coexistence of these conditions, providing valuable insights into risk factors and possible preventive measures.

  • 4. Clinical management challenges: Documenting the clinical course and management strategies employed for neonates with CHDs and extra-cardiac anomalies will shed light on the challenges faced by healthcare providers. This information can inform the development of targeted interventions and improve the overall quality of care for these complex cases.

  • 5. Contribution to existing knowledge: The study aims to contribute to the existing body of knowledge regarding the association between CHDs and extra-cardiac anomalies, particularly in Central India. The findings may enhance existing clinical guidelines and pave the way for further research in neonatal cardiology.

Sample size

The calculation of the sample size for this study involves several vital parameters. With a defined population size (N) of 1000, a hypothesised percentage frequency of the outcome factor (p) set at 8% with a margin of error of ±5%, and confidence limits (d) set at 5% of 100, the sample size is determined to be 114. The design effect (DEFF), used for cluster surveys and, in this case, is considered 1, is factored into the calculation. Additionally, a confidence level of 95% is applied to ensure the reliability and statistical significance of the study findings. Consequently, the calculated sample size of 114 is expected to provide a representative and robust dataset for investigating the association between extra-cardiac anomalies and congenital heart diseases in neonates within the specified tertiary care hospital setting.

Ethical considerations

The Institutional Ethics Committee of Datta Meghe Institute of Higher Education and Research (DU) has granted its approval to the study protocol (Reference number: DMIHER (DU)/IEC/2023/900. Date:31-03-2023). Before commencing the study, we will obtain written informed consent from all participants, providing them with a comprehensive explanation of the study’s objectives.

Dissemination

After the completion of the study, we will publish it in an indexed journal or conference.

Study status

The study is yet to be started. After the publication of the protocol, we will start recruitment in the study.

Discussion

Understanding the prevalence of extra-cardiac anomalies in neonates with CHDs is essential for informing clinical decision-making and resource allocation. Previous studies have demonstrated varying prevalence rates globally, emphasising the need for population-specific investigations.5 By focusing on a Central Indian population, this study seeks to contribute data that can enhance the accuracy of prevalence estimates and provide insights into the disease burden in this region.

Exploring the clinical outcomes of neonates with CHDs and additional extra-cardiac anomalies is paramount for optimizing patient care. The literature indicates that the presence of extra-cardiac anomalies can significantly impact prognosis and management strategies.6 This study aims to provide a comprehensive understanding of the challenges encountered in the management of these complex cases, potentially guiding the development of tailored intervention strategies.

The examination of demographic factors such as gestational age and birth weight, alongside an exploration of potential etiological factors, adds depth to our understanding of the complex interplay between genetic and environmental influences in the development of CHDs and extra-cardiac anomalies.3 The proposed study aligns with current research trends that emphasize the importance of elucidating these factors to inform preventive measures and genetic counseling.

The adoption of a descriptive, interventional cross-sectional study design provides a snapshot of the prevalence and clinical outcomes in a specific timeframe, allowing for efficient data collection and analysis. While the study is conducted within a tertiary care hospital, the findings can contribute valuable insights that may be applicable to similar settings in Central India.

The proposed statistical analysis, including chi-square tests, Fischer’s tests, and independent t-tests, reflects a robust approach to exploring relationships between demographic and clinical characteristics. This aligns with best practices in quantitative research, enhancing the rigor and validity of the study’s conclusions.7

Anticipated results from this study will likely contribute to the existing body of knowledge by shedding light on the prevalence and clinical implications of extra-cardiac anomalies in neonates with CHDs in Central India. The findings can inform evidence-based clinical guidelines and may serve as a foundation for future longitudinal studies and interventions aimed at improving outcomes in this vulnerable population.

Data availability

No data are associated with this article.

Extended data

Repository: Proforma for the data collections ‘Interventional Cross-sectional study of extra-cardiac anomalies in children with congenital heart diseases in tertiary care hospital in central India’, https://doi.org/10.5281/zenodo.10147069. 8

References

  • 1.  Bernier P-L, Stefanescu A, Samoukovic G, et al.: The challenge of congenital heart disease worldwide: epidemiologic and demographic facts. Semin. Thorac. Cardiovasc. Surg. Pediatr. Card. Surg. Annu. 2010; 13: 26–34. PubMed Abstract | Publisher Full Text
  • 2.  Alvarado JL, Bermon A, Florez C, et al.: Outcomes and Associated Extracardiac Malformations in Neonates from Colombia with Severe Congenital Heart Disease. Pediatr. Cardiol. 9 October 2023; 45: 55–62. PubMed Abstract | Publisher Full Text
  • 3.  van der Linde D , Konings EEM, Slager MA, et al.: Birth prevalence of congenital heart disease worldwide: a systematic review and meta-analysis. J. Am. Coll. Cardiol. 2011; 58: 2241–2247. Publisher Full Text
  • 4.  Hoffman JIE, Kaplan S: The incidence of congenital heart disease. J. Am. Coll. Cardiol. 2002; 39: 1890–1900. Publisher Full Text
  • 5.  Jenkins KJ, Correa A, Feinstein JA, et al.: Noninherited risk factors and congenital cardiovascular defects: current knowledge: a scientific statement from the American Heart Association Council on Cardiovascular Disease in the Young: endorsed by the American Academy of Pediatrics. Circulation. 2007; 115: 2995–3014. PubMed Abstract | Publisher Full Text
  • 6.  Mahle WT, Clancy RR, Moss EM, et al.: Neurodevelopmental outcome and lifestyle assessment in school-aged and adolescent children with hypoplastic left heart syndrome. Pediatrics. 2000; 105: 1082–1089. PubMed Abstract | Publisher Full Text
  • 7.  Altman DG, Schulz KF, Moher D, et al.: The revised CONSORT statement for reporting randomized trials: explanation and elaboration. Ann. Intern. Med. 2001; 134: 663–694. Publisher Full Text
  • 8.  Sindhuja BG: Proforma for the data collections ‘Prospective comparative randomized clinical study for the comparison of two different doses of dexmedetomidine with bupivacaine in pediatric caudal anesthesia for infraumbilical surgeries in a tertiary hospital in central India’. Zenodo. 2023. Publisher Full Text

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Khandelwal RY and Vagha J. 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: 1 approved with reservations]. F1000Research 2024, 13:345 (https://doi.org/10.12688/f1000research.144932.1)
NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article.
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Reviewer Report 06 Jan 2025
Kwadwo Danso, Pediatrics, University of Illinois Chicago College of Medicine at Peoria, Peoria, Illinois, USA 
Approved with Reservations
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https://doi.org/10.5256/f1000research.158802.r351534
The study identifies an important clinical conundrum of public health essence worth exploring. The methodology is sound with well-outlined and achievable outcomes. However, the authors did not mention how they would acquire the controls for the study per their second ... Continue reading
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Danso K. Reviewer Report For: 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: 1 approved with reservations]. F1000Research 2024, 13:345 (https://doi.org/10.5256/f1000research.158802.r351534)
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  1. Kwadwo Danso, University of Illinois Chicago College of Medicine at Peoria, Peoria, USA

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    Alongside their report, reviewers assign a status to the article:
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    Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit.
    Not approved - fundamental flaws in the paper seriously undermine the findings and conclusions
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