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CTRI Number  CTRI/2023/10/058967 [Registered on: 20/10/2023] Trial Registered Prospectively
Last Modified On: 15/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   To study ventricular functions of the heart in late onset sepsis of newborn infants by echocardiography 
Scientific Title of Study   Myocardial performance index and its association with late onset neonatal sepsis : a prospective observational study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Arshdeep Kaur 
Designation  DM, Senior Resident  
Affiliation  Bharati Vidyapeeth Deemed University Medical College, Pune 
Address  NICU, second floor, Bharati Hospital, Dhankawadi, Pune Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9815961268  
Fax    
Email  kaurarshdeep57@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Sujata Deshpande  
Designation  Professor, Department of Neonatology, Bharati Vidyapeeth Deemed University Medical College, Pune 
Affiliation  Bharati Vidyapeeth Deemed University Medical College,Pune 
Address  NICU, second floor, Bharati Hospital, Dhankawadi, Pune Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  8983944670  
Fax    
Email  sujata.deshpande@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Arshdeep Kaur 
Designation  DM, Senior Resident  
Affiliation  Bharati Vidyapeeth Deemed University Medical College, Pune 
Address  NICU, second floor, Bharati Hospital, Dhankawadi, Pune Pune MAHARASHTRA 411043 India

Pune
MAHARASHTRA
411043
India 
Phone  9815961268  
Fax    
Email  kaurarshdeep57@gmail.com  
 
Source of Monetary or Material Support  
Bharati Vidyapeeth Deemed University Medical College, Pune 
 
Primary Sponsor  
Name  Bharati Vidyapeeth Deemed University Medical College, Pune 
Address  NICU, Bharati Hospital, Dhankawadi, Pune 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil   nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Arshdeep Kaur  Bharati Hospital, Pune  Department of Neonatology, Division of ICU, Room NICU Pune MAHARASHTRA Pune MAHARASHTRA
Pune
MAHARASHTRA 
9815961268

kaurarshdeep57@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Bharati Vidyapeeth Deemed University Medical College Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: P399||Infection specific to the perinatal period, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  3.00 Day(s)
Age To  28.00 Day(s)
Gender  Both 
Details  Term and preterm neonates admitted to NICU during the study period and clinically suspected to have late onset sepsis ( onset after 72 hours of life)  
 
ExclusionCriteria 
Details  1. Moderate to severe hypoxic ischemic encephalopathy with pH <7 at birth or APGAR less than 5 at 5 mins
2. Congenital heart disease
3. Major congenital malformations
4. Neonates on inotropic support or received inotropes in last 24 hours at the time of enrolment
5. Haemodynamically significant patent ductus arteriosus  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure myocardial performance index using targeted echocardiography in neonates with clinically suspected late onset sepsis and determine its association with proven and probable sepsis   as soon as possible after the onset of clinical signs of sepsis and before initiation of fluid resuscitation/ inotropic support if required 
 
Secondary Outcome  
Outcome  TimePoints 
1)To determine the correlation between myocardial performance index and C-Reactive Protein (CRP) in neonates with late onset sepsis
2)To determine association of myocardial performance index and outcomes such as inotropic support, duration of hospital stay, mortality in neonates with late onset sepsis
3)To measure other right and left ventricular functions in neonates with suspected late onset neonatal sepsis and determine their association with late onset sepsis
 
as soon as possible after the onset of clinical signs of sepsis and before initiation 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   28/10/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The role of targeted neonatal echocardiography (TnECHO) for the evaluation of hemodynamic status in stable as well as sick infants has been well established over the last few years. Its impact in the clinical setting is less well understood. Early recognition of cardiovascular compromise in sick infants enables the physician to take timely therapeutic decisions and monitor response to treatment more objectively.

Neonatal sepsis is a clinical syndrome characterized by systemic signs of infection and accompanied by bacteremia in the first month of life. It has been classified as either early onset sepsis (EOS) (0-72 hours of life) or late onset sepsis (LOS) (72 hours-28 days of age). Neonatal sepsis is a cause of significant short term as well as long term morbidity and mortality among term and preterm infants. 

Cardiac dysfunction is a well-recognized complication of neonatal sepsis and is a major contributor to morbidity and mortality in patients with sepsis. Hemodynamic response to sepsis has been less well-characterized in neonates compared with children and adults. Clinical variables to assess hemodynamic status of sick newborn infants such as heart rate, blood pressure and capillary refill time have been demonstrated to be misleading in their accuracy.  It has been demonstrated in several studies that real time objective physiologic data obtained by targeted echocardiography such as cardiac contractility, cardiac output and diastolic functions of heart provide hemodynamic information, which may be different from the assumed underlying physiology.

Cardiac parameters using conventional echocardiography such as superior vena cava flow and cardiac output in neonatal sepsis exist in literature. Systolic and diastolic dysfunction are known to coexist in neonatal sepsis, therefore, an echocardiographic doppler index that combines measures of systolic and diastolic dysfunction is needed. The evaluation of myocardial performance in septic neonates is of critical importance to identify the haemodynamic instability and to predict prognosis. However traditional indices of myocardial function, including cardiac index, stroke volume index, and ejection fraction, may be inaccurate because a significant decline in contractility can be masked by changes in heart rate, preload, and afterload. Tissue doppler imaging (TDI) is an emerging echocardiographic technique that is useful for quantifying myocardial tissue motion. It is easily reproducible and less preload and afterload dependent than conventional doppler techniques. Myocardial performance index (MPI) by using TDI is a powerful quantitative parameter that measures both systolic and diastolic cardiac functions and is independent of heart rate and blood pressure. Indian data on use of tissue doppler imaging for assessment of myocardial dysfunction in sepsis is scarce.

In this study, we aim to measure myocardial performance index using targeted echocardiography in neonates with clinically suspected late onset sepsis, and determine its association with laboratory proven sepsis. We have selected patients with late onset sepsis, as in the first 24-72 hours, newborn infants may be in transitional phase of circulation which may confound echocardiographic findings. Also in our unit, majority of neonates with early onset sepsis have culture negative sepsis, likely due to maternal antibiotics. We expect that the results of our study may help us to understand the value of MPI in neonatal sepsis and to determine whether it has any role in prediction or prognostication of sepsis.

 

 

 

 

 
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