| 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
|
|
|
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
|
|
|
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. |