| CTRI Number |
CTRI/2017/12/010766 [Registered on: 06/12/2017] Trial Registered Retrospectively |
| Last Modified On: |
12/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Case Control Study |
| Study Design |
Other |
|
Public Title of Study
|
To estimate echocardiographic parameters in neonates with septic shock: A prospective observational study |
|
Scientific Title of Study
|
To estimate echocardiographic parameters in neonates with septic shock: 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 |
Kumari Gunjan |
| Designation |
DNB Fellow Neonatology |
| Affiliation |
Sir Gangaram hospital |
| Address |
Flat no.47 F Sector 8 Jasola Vihar
Sir Gangaram hospital , Old Rajinder Nagar
New Delhi
DELHI
110025
India |
| Phone |
9643083242 |
| Fax |
|
| Email |
dr.gunjan.mishra06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Satish Saluja |
| Designation |
Chairperson , Department of Neonatology , Sir Gangaram Hospital, New Delhi |
| Affiliation |
Sir Gangaram hospital |
| Address |
Sir Gangaram Hospital, Old Rajinder Nagar
Sir Gangaram hospital , Old Rajinder Nagar
New Delhi
DELHI
110060
India |
| Phone |
9811047389 |
| Fax |
|
| Email |
satishsaluja@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kumari Gunjan |
| Designation |
DNB Fellow Neonatology |
| Affiliation |
Sir Gangaram hospital |
| Address |
Flat no.47 F Sector 8 Jasola Vihar
Sir Gangaram hospital , Old Rajinder Nagar
New Delhi
DELHI
110025
India |
| Phone |
9643083242 |
| Fax |
|
| Email |
dr.gunjan.mishra06@gmail.com |
|
|
Source of Monetary or Material Support
|
| SIR GANGARAM HOSPITAL, Old Rajinder Nagar, New Delhi, PIN: 110060 |
|
|
Primary Sponsor
|
| Name |
Not Applicable |
| Address |
SIR GANGARAM HOSPITAL, NEW DELHI |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| KUMARI GUNJAN |
SIR GANGARAM NICU |
Neonatal Intensive Care Unit , First Floor, Old building, Sir Gangaram Hospital
New Delhi
DELHI |
9643083242
dr.gunjan.mishra06@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee,Sir Gangaram Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
septic shock and gestation and postnatal age matched healthy controls, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
Study subjects:
All neonates in NICU of Sir Ganga Ram Hospital, New Delhi with diagnosis of
septic shock either at admission or during NICU stay.
Controls: Gestation (in completed whole weeks) and postnatal age matched (±5 days)
hemodynamically stable neonates, without features of shock. |
|
| ExclusionCriteria |
| Details |
– Perinatal asphyxia
– Structural congenital heart disease
– Neonates who already received inotropes at time of admission
– Failure to obtain parental consent |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To estimate echocardiographic parameters of neonates with septic shock |
At the time of diagnosis of clinical septic shock |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare echocardiographic parameters of neonates with septic shock with gestational age and postnatal age compared healthy controls. |
During study period |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "66"
Final Enrollment numbers achieved (India)="66" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/07/2017 |
| Date of Study Completion (India) |
31/05/2019 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Functional echocardiography is an emerging tool for non-invasive hemodynamic assessment of
preload, myocardial contractility, cardiac output and organ flows. Bedsides, real time
echocardiographic assessment in neonates with poor perfusion may help in discerning underlying
mechanisms involved in different types of shock. This information may be useful for targeted
treatment of shock in future. So far, limited data is available on echocardiograhic parameters in
neonates with shock. In our present observational study, we plan to evaluate functional
echocardiograhic parameters in neonates at time of detection of shock and to compare these with
hemodynamically stable neonates.
|