Evaluation of Echocardiography in Neonates in Neonatal intensive care unit.

Title of Article: STUDY PROTOCOL: Evaluation of Echocardiography in Sick Neonates in Neonatal intensive care unit (NICU). Abstract Background: Echocardiography plays an increasing role in neonatal intensive care units, and neonatologists increasingly use it to make clinical decisions. It is the utilization of cardiac ultrasound at the bedside to assess longitudinal changes in both functional and hemodynamic parameters. Information that reflects cardiovascular capacity and systemic and pulmonary blood flow in preterm and term neonates can be observed. Analyzing hemodynamics via echocardiography at the bedside may be considered an addition to the clinical examination to assess cardiovascular wellbeing in critically ill infants. Our primary goal in this study is to determine whether sick neonates have heart structural or functional abnormalities via echocardiography. Objectives: To determine the correlation between echocardiographic indications and intervention in sick newborns. Material & Methods: This prospective cross-sectional study will be conducted in the Neonatology Department, JNMC, Sawangi, Wardha. Each sick newborn will be asked for demographic information, including age, gender, gestational age (GA), and birth weight. All sick neonates admitted to NICU will be selected as per the inclusion criteria in a non- randomized manner and will be subjected to echocardiography. If echocardiography reveals any abnormal findings, they will be followed up for any sequelae. The indications for echocardiography, the echocardiographic results and any changes in clinical management will be decided. Result: After completing the study, we will know the indication of echocardiography in sick neonates. We will come to see the prevalence of      prevalence of cardiac structural or functional abnormality in sick neonates. Conclusion: This study will provide a cardiac structural or functional abnormality in the sick newborns. Keywords: Cardiac Function, Sick Newborn, Echocardiography, Neonatology INTRODUCTION A delayed diagnosis of critical congenital heart disease (CCHD) can lead to cardiac failure, cardiovascular collapse, and even death if not diagnosed early. CCHD in the newborn may have low oxygen saturations unrecognized clinically. Over the past few years, the role of echocardiography in neonatal intensive care units (NICUs) has changed. The role of echocardiography in neonatal intensive care units is rapidly evolving, and increasingly neonatologists are using it in making clinical decisions in sick infants. Functional echocardiography is the bedside utilization of cardiac ultrasound to take after functional and haemodynamic changes longitudinally. Information that reflects cardiovascular capacity and systemic and pulmonary blood flow in preterm and term neonates can be observed. In critically ill infants, echocardiography provides direct assessment of hemodynamics at the bedside and can be considered an extension of the clinical examination to assess cardiovascular wellbeing (1-2). The physiological information may target specific interventions based on the underlying pathophysiology. In a neonatal intensive care setting, echocardiography is used to diagnose pulmonary hypertension, patent ductus arteriosus, hemodynamic evaluation, assessment of cardiac function, and recognition of pericardial effusion and cardiac tamponade (3-4). In considering the differential diagnosis of a newborn presenting with cyanosis, cardiorespiratory distress, and a shocklike appearance, the physician must include congenital heart disease, other causes of heart disease such as myocarditis, and pulmonary, central nervous system, hematologic, infectious, and metabolic diseases. The physical examination, electrocardiographic, and chest X-ray findings during the early neonatal period may fail to reliably identify patients with congenital heart disease in the first few days of life. In contrast, because echocardiography displays cardiac anatomy, it can immediately provide the information needed to separate most patients with significant congenital heart disease from the others. The gold standard diagnostic tool for evaluating hemodynamic stability in patients with pericardial effusion, cardiac tamponade, and cardiac abnormalities such as congenital heart defects or valve problems is echocardiography (4-6). Further, in some of the defects, the echocardiographic findings are sufficient and unique enough for an accurate diagnosis (5-7). Data on echocardiographic utility in sick neonates in NICU at the rural hospital are minimal. Research question Do sick neonates in NICU have cardiac structural or functional abnormalities? Our Hypothesis Our hypothesis is that sick neonates have cardiac abnormalities which correlate with the neonatal outcome. Aims & Objectives Aim: To find out the prevalence of cardiac structural or functional abnormality in sick neonates by echocardiography. Objectives: ï‚· To know the association between echocardiography indications and intervention. ï‚· To know the association between echocardiography indication and neonatal outcome. ï‚· To find out the correlation of cardiac abnormality with neonatal outcome. MATERIALS AND METHODS a. Study Setting This study will be conducted in the Neonatology unit, “Department of Pediatrics, in Jawaharlal Nehru Medical College & AVBR Hospital, Sawangi, Wardhaâ€. b. Sources of Data Study members: All members in this study will be critically ill sick neonates who will be admitted to the NICU. All sick neonates admitted to NICU will be selected as per the inclusion criteria in a non-randomized manner and will be subjected to echocardiography on selected days. If echocardiography reveals any abnormal findings, they will be followed up for any sequelae. Follow-up echocardiography will be done in the case of the presence of any findings. Morphology of conclusions will be studied and recorded, and clinical correlation with various findings on echocardiography will be done. Neonates will be followed till recovery and discharge from NICU. Information about all echocardiograms performed on the neonatal unit will be collected prospectively. Indications for echocardiography, echocardiographic findings, and any changes in clinical management will be determined. Inclusion & Exclusion Criteria Inclusion criteria ï‚· Sick neonates in NICU. ï‚· Written informed consent given by the parents Exclusion Criteria ï‚· Full term healthy neonates maintaining oxygen saturation. ï‚· Neonates in NICU with hyperbilirubinemia only for phototherapy. ï‚· Newborns after exchange transfusion ï‚· Congenital malformation c. Study Design: Cross-Sectional study d. Time Frame / Duration: 3 year e. Methodology A detailed information sheet will be given to the newborn parents in which the methodology of treatment will explain in their local language. Due permission of the ethics committee of the institute will be taken before starting the study. f. Assessments Demographic information will be collected for all sick neonates (study cases), including age, gender, gestational age(GA), and birth weight. For all study cases, perinatal history and clinical examination were made. Laboratory examinations will be included a complete blood picture, blood grouping, and a peripheral smear(ps) test will also be done in all study cases. Definition of Sick Neonates includes high-risk neonates with any of the following: Neonatal convulsions, birth asphyxia and hypoxic-ischemic encephalopathy(HIE), respiratory distress, neonatal sepsis, preterm neonates, neonates born out of traumatic/instrumental labour, metabolic disturbances with convulsions, congenital malformation of the central nervous system, and neural tube defects. Factors identifying the neonate as a “sick neonate†will be assessed by taking detailed maternal history and looking into perinatal and antenatal records. All sick neonates admitted to NICU will be selected as per the inclusion criteria in a non- randomized manner and will be subjected to echocardiography on selected days. If echocardiography reveals any abnormal findings, they will be followed up for any sequelae. Follow-up echocardiography will be done in the case of the presence of any findings. Morphology of conclusions will be studied and recorded, and clinical correlation with various findings on echocardiography will be done. Neonates will be followed till recovery and discharge from NICU. Information about all echocardiograms performed on the neonatal unit will be collected prospectively. Indications for echocardiography, echocardiographic findings, and any changes in clinical management will be determined. h. Echocardiography examination We will be used M-mode and 2D-Echo to measure the LV diameter during systole and diastole and also to measures the thickness of IVS during diastole and also thickness of LV posterior wall. The fractional shortening and ejection fraction will be measured by the m- mode and simpson methods. All echocardiographic data will be taken as per American Society of Echocardiography (8-9). VARIABLES We will do the following Important VARIABLE ï‚· Cause of Sick Neonates ï‚· Gestational Age ï‚· Birth weight ï‚· Intervention (Medical or Surgical) ï‚· Congenital heart disease ï‚· M Mode ( FS & EF for the systolic function of the heart ) ï‚· Pulse-Doppler (Diastolic function of the ventricle ) Sample size calculation Population size(for finite population correction factor or fpc)(N): 10000 Hypothesized % frequency of outcome factor in the population (p) 8%+/-5 Confidence limits as % of 100(absolute +/- %)(d) 5% Design effect (for cluster surveys-DEFF) 1 Confidence level (%) 95% Sample size Required 114 Formula used for calculation of Sample size  n = [DEFF*Np(1-p)]/ [(d 2 /Z 2 1-α/2 *(N-1)+p*(1-p)]  Statistical Analysis Data will be entered into Microsoft Excel sheet and statistical analysis will be done on statistical software STATA 12. For descriptive statistics, mean±standard deviationwill be used, median and interquartile range for quantitative variables, and percentage with number for categories. Relationshipof various demographic, clinical characteristics and echocardiography diagnosis with outcome will be evaluatedemploying Chi-square test, Fischer’s exact test for categorical data and independent t test forcontinuous data with normal distribution. Spearman (parametric) or Pearson (non-parametric)correlations will be applied to determine the association between dependent and independent variables. P value will be considered significant if less than 0.05. Expected Result After completion of the study we will come to know the indication of the echocardiography in sick neonates. We will come to know the prevalence of prevalence of cardiac structural or functional abnormality in sick neonates To find out the correlation of cardiac abnormality with neonatal outcome. We will come to know that in how many cases this investigation will changed the clinical management and neonatal outcome. Discussion Congenital heart defects (CHD) are a leading cause of infant deaths in the developed world. A delayed diagnosis of CHD was associated with a worse preoperative condition. Echocardiography is being utilized progressively in the neonatal unit and has been indicated to have a high return for structural and functional cardiac abnormalities. Echocardiography has substantially improved the care of the neonate with a hemodynamically significant patent arterial duct, the hypotensive infant, the cyanosed infant with or without persistent pulmonary hypertension of the newborn, the dysmorphic infant, and the infant with a heart murmur in the intensive care unit (9-10). An echocardiogram in the neonatal unit is used in critically ill infants to diagnose or exclude suspected congenital heart disease and assess cardiovascular function. In the hypotensive or shocked infants, there is no better way to find a treatable underlying cause of their circulatory failure. Myocardial dysfunction, a sizeable ductal shunt, and hypertrophic cardiomyopathy in infants of diabetic mothers are all examples of circulatory failure that could be diagnosed or excluded by echocardiography (11-12). Brown KL et al. (11) reported that 25% of infants with CCHD were not diagnosed with heart disease until after discharge from the nursery. Several children with CCHD are so severely compromised at the presentation that they die before surgical intervention. CCHDs are structural heart defects often associated with hypoxia among infants during the newborn period. Infants with CCHDs are at risk for significant morbidity or mortality early in life because of the closing of the ductus arteriosus or other physiologic changes. A retrospective study was conducted on sick neonates to evaluate the influence of echocardiographic examination on the clinical management Kadivar M et al. (10). The most common clinical indications for an echocardiogram were asymptomatic murmurs (45%) followed by extracardiac anomalies/dysmorphic features (24%). The congenital structural abnormalities (33%), hemodynamically significant patent arterial duct (3%), persistent pulmonary hypertension of the newborn (6%), and left ventricular dysfunction (3%) were the echocardiographic findings. Another study was conducted by S Moss et al. (13 ) on the evaluation of echocardiography in the neonatal unit. He reported 44 infants with a structural cardiac abnormality and a further 17 infants with a trivial abnormality by echocardiography. Echocardiography prompted a specific change in clinical management in 64 (78%) babies. Du ZD et al. (14) stated his study stated that 84% of heart murmurs in neonates were due to heart diseases, and only 16% were innocent murmurs. Chioukh FZ et al. ( 15) reported that the main signs indicating the echocardiogram were the heart murmur (22 cases) followed by cyanosis (6 patients). A malformation association or a chromosomal aberration have been noted in 36% of cases. Another study conducted to evaluate the cardiac status of newborns by Arshad MS et al. (16 ) indicated that 1523 (55.8%) newborns as structurally and functionally normal, 866 (31.7%) had congenital heart disease, 69 (2.5%) duct dependent lesions, 248 (9.1%) persistent pulmonary hypertension and 23 (0.8%) left ventricular (LV) dysfunction but with a structurally normal heart. The prospective observational study of neonates in a tertiary Neonatal Intensive Care Unit (NICU) in Pune (India) was done by Khamkar AM et al. (17) mentioned that the most frequent indication for functional echocardiography ( FnECHO ) were Patent Ductus Arteriosus (PDA) assessment (n= 174, 50%), followed by haemodynamic instability (n=43, 12.36%). They reported that the results of FnECHO modified treatment in 148 cases (42.50%) in addition and change in the treatment or avoidance of unnecessary intervention. This retrospective study conducted by Maliheh Kadivar et al. (10) reported that echocardiography changed the clinical management in at least 66% of newborns scanned, including emergency surgical intervention for 7%, medical treatment for 22%, and routine cardiologic followup for 37% of patients. Another retrospective study conducted by. Hossein AM et al. (18) recommended that cardiac causes be more considered in term and near-term newborns with respiratory distress in addition to the previous inclusion criteria of the neonates admitted to NICU requiring echocardiography, including prolonged respiratory distress murmurs and rales. We will disseminate the results of this research via publication in high-impact peer-reviewed journals, and presentation at international conferences. Outcome measures ï‚· The primary outcomes will be a to assess the cardiac structural or functional abnormalities of sick neonates in NICU ï‚· The secondary outcome will be to know the association between echocardiography indications and intervention (Medical or surgical) and the relationship between echocardiography indication and neonatal outcome.  Scope of the study · Echocardiography is widely used for diagnosing cardiac structural or functional abnormalities as it is a non-invasive, readily available investigation. · Minimal data on echocardiography utility in sick neonates in the NICU at the rural hospital. · Heart murmur in neonates could be a symptom of CHD, and timely echocardiography is essential in diagnosing the type of disease. Limitation · Area of coverage will be single centre study Implication · After completing the study, we will know the percentage of changes in the management of the newborns after the echocardiography scan. Also, after echocardiography, we will get an idea of the neonatal outcomes of the sick newborn in the intensive care unit.