| CTRI Number |
CTRI/2020/05/025378 [Registered on: 27/05/2020] Trial Registered Prospectively |
| Last Modified On: |
24/05/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Genetic susceptibility of a preterm infant to develop retinopathy of prematurity |
|
Scientific Title of Study
|
Genetic Polymorphism and risk of development of retinopathy of prematurity |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mannat Giran |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College & Hospital,Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College & Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
8360466102 |
| Fax |
|
| Email |
mannatgiran@hotmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subina Narang |
| Designation |
Associate Professor |
| Affiliation |
Government Medical College & Hospital Chandigarh |
| Address |
Department of Ophthalmology
Government Medical College & Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
subina_navya@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mannat Giran |
| Designation |
Junior Resident |
| Affiliation |
Government Medical College & Hospital |
| Address |
Department of Ophthalmology
Government Medical College & Hospital
Sector 32
Chandigarh
Chandigarh
CHANDIGARH
160032
India |
| Phone |
|
| Fax |
|
| Email |
mannatgiran@hotmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College & Hospital Chandigarh |
|
|
Primary Sponsor
|
| Name |
Government Medical College Hospital |
| Address |
Government Medical College & Hospital
Sector 32
Chandigarh |
| Type of Sponsor |
Government 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 Mannat Giran |
Government Medical College & Hospital |
Department of Ophthalmology
Retina Services
D- Block, Level - 3
Chandigarh
CHANDIGARH |
8360466102
mannatgiran@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H351||Retinopathy of prematurity, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
6.00 Month(s) |
| Gender |
Both |
| Details |
Infants with
1. Gestation age of 34 weeks or less
2. Birth weight of 1750 grams or less
3. Gestation age of 34-36 weeks or 1750-2000 g birthweight with risk factors for ROP |
|
| ExclusionCriteria |
| Details |
Infants with
1. Media opacities
2. Major Congenital abnormalities |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The association of VEGF and TNF gene polymorphism with risk of development of retinopathy of prematurity
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| The association of VEGF and TNF gene polymorphism with severity of retinopathy of prematurity |
Day 14
Month 3
Month 6 |
|
|
Target Sample Size
|
Total Sample Size="105"
Sample Size from India="105"
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)
|
29/05/2020 |
| 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="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a hospital based cross sectional observational study to evaluate VEGF and TNFα gene polymorphism as a predictor for development of retinopathy of prematurity and its severity in premature infants. |