| CTRI Number |
CTRI/2017/09/009654 [Registered on: 05/09/2017] Trial Registered Prospectively |
| Last Modified On: |
04/09/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
normal values of echo parameters in neonates below 1500 gram birth weight |
|
Scientific Title of Study
|
Normative values of echocardiographic functional parameters in stable VLBW neonates during first month of life |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Manoj Modi |
| Designation |
Associate consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9873266331 |
| Fax |
9873266331 |
| Email |
drmanojmodi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Manoj Modi |
| Designation |
Associate consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9873266331 |
| Fax |
9873266331 |
| Email |
drmanojmodi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Manoj Modi |
| Designation |
Associate consultant |
| Affiliation |
Sir Ganga Ram Hospital |
| Address |
Rajinder nagar
New Delhi
New Delhi
DELHI
110060
India |
| Phone |
9873266331 |
| Fax |
9873266331 |
| Email |
drmanojmodi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Manoj Modi
Department of neonatology
Sir Ganga Ram hospital
Rajinder nagar
New Delhi |
|
|
Primary Sponsor
|
| Name |
Manoj Modi |
| Address |
Sir Ganga Ram Hospital
Rajinder nagar |
| Type of Sponsor |
Other [self] |
|
|
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 Manoj Modi |
Sir Ganga Ram hospital |
Department of Neonatology
Sir Ganga Ram hospital
Rajinder nagar
Central
DELHI |
9873266331
drmanojmodi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics committee, Sir Ganga Ram hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
stable very low birth weight infants admitted to NICU, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
30.00 Day(s) |
| Gender |
Both |
| Details |
stable very low birth weight neonates admitted to NICU at Sir Ganga Ram hospital, New Delhi within 24 hrs of life |
|
| ExclusionCriteria |
| Details |
1 - perinatal asphyxia
2 - need for inotropes
3 - MAP > 15 on mechanical ventilation
4 - congenital heart disease |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1 -Left ventricular output
2 -Right ventricular output
3 -Superior vena cava flow
4 -Myocardial shortening fraction
5 -Inferior vena cava dimensions
|
day 3, 7, 14, 21, 28, discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 -Spontaneous closure of PDA
2 -Need for pharmacological closure
3 -need for surgical ligation |
day 3, 7, 14, 21, 28, discharge |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
30/09/2017 |
| 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="30" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is an observational study of echocardiographic functional parameters in very low birth weight neonates admitted to NICU at Sir Ganga Ram hospital, New Delhi. All stable neonates <1500 grams at birth, admitted to NICU within 24 hrs of life will be enrolled and echocardiographic assessment of left ventricular output, right ventricular output, superior vena cava flow, inferior vena cava dimensions, myocardial shortening fraction will be measured at Day 3, 7, 14, 21, 28 and at discharge. Presence of patent ductus arteriosus (PDA) and various parameters of hemodynamic significance of ductus (duct size, flow pattern, duct flow velocity, left atrium to aortic root ratio, turbulance in main pulmonary artery, reversal of flow in post ductal aorta will be noted. spontaneous closure rates of PDA and proportion of neonates requiring pharmacological and surgical intervention for closure of PDA will be noted. Duct closure will be consider neonate is on invasive ventilation with FiO2 >30% and on echocardiograhy :if PDA is low velocity (<1.5 meter/sec) with left atrium to aortic root ratio >1.8. |