| CTRI Number |
CTRI/2018/09/015809 [Registered on: 24/09/2018] Trial Registered Prospectively |
| Last Modified On: |
08/01/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing heart function in preterm newborns using ultrasound examination of heart. |
|
Scientific Title of Study
|
Assessing myocardial strain pattern in a cohort of preterm neonates - A prospective observational study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sreedhara M S |
| Designation |
DM Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Resident in neonatology.
Sri Ramachandra Medical College and Research Institute.
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9538760307 |
| Fax |
|
| Email |
drsreedharms@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prakash A |
| Designation |
Head Of the Department |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Department of Neonatology
Sri Ramachandra Medical College and Research Institute.
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9791181566 |
| Fax |
|
| Email |
neosrmc@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sreedhara M S |
| Designation |
DM Resident |
| Affiliation |
Sri Ramachandra Medical College and Research Institute |
| Address |
Resident in neonatology.
Sri Ramachandra Medical College and Research Institute.
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9538760307 |
| Fax |
|
| Email |
drsreedharms@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Medical College and Research Institute. Porur. Chennai. 600116 |
|
|
Primary Sponsor
|
| Name |
SRMC and RI |
| Address |
Sri Ramachandra Medical College and Research Institute.
Porur
Chennai |
| 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 Sreedhara M S |
SRMC, chennai |
Sri Ramachandra Medical Center.
Udayar Block.
Department of neonatology.
C3. 3rd flood NICU
Chennai
TAMIL NADU |
9538760307
drsreedharms@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research Ethics Committee, SRMC and RI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Preterm neonates less than 32 weeks. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
28.00 Day(s) |
| Gender |
Both |
| Details |
Preterm neonates 32 weeks and less |
|
| ExclusionCriteria |
| Details |
Major congenital malformations.
First study not performed within 72 hours. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
BPD
Hemodynamicaly significant PDA
Death.
Need for transfusion
Need forinotropes during sepsis epsiodes |
34 week pma or dischargewhich ever is later |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Duration of NICU stay
Duration of ventilation
Ivh |
34 weeks pma or discharge |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
25/09/2018 |
| 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="1"
Months="6"
Days="1" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Assessment of myocardial function in neonates by strain analysis in echocardiography is a relatively new method. Although strain analysis is an established tool for myocardial function assessment in adults, it’s feasibility, application and interobserver variability are not studied in preterm neonates. We aim to study myocardial function in preterm neonates 32 weeks or less using this tool. Prospectively 100 neonates admitted to our Nicu will be studied at birth and then at multiple time points 1 week, 2 week, and then at 34 weeks. While echocardiography studies are performed at prespecified time points, strain analysis will be done only after the baby is discharged in an offline mode using the software q lab in a computer. The normal pattern of strain at various time points will be noted, and also whether strain pattern correlates with some major neonatal morbidities like BPD, hemodynamically significant PDA, need for transfusions, sepsis episodes with initropes requirement will be studied. Some of the study loops will be analysed for strain pattern by an external investigator and interobserver variability will be calculated. |