| CTRI Number |
CTRI/2025/05/086792 [Registered on: 13/05/2025] Trial Registered Prospectively |
| Last Modified On: |
11/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to see the relationship between the disease of premature children (Retinopathy of prematurity) and decreased platelet counts. |
|
Scientific Title of Study
|
An observational study to access the relationship between retinopathy of prematurity and thrombocytopenia. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sunil Kumar Gurjar |
| Designation |
Resident Doctor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room no C8, ground floor, Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414137394 |
| Fax |
|
| Email |
sunil.gurjar.9887@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sandeep Parwal |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room no C8, ground floor, Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107474333 |
| Fax |
|
| Email |
sandeepparwal1983@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sandeep Parwal |
| Designation |
Professor |
| Affiliation |
SMS Medical College and Hospital, Jaipur |
| Address |
Room no C8, ground floor, Department of Ophthalmology, Sawai Man Singh Medical College and Hospital, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
8107474333 |
| Fax |
|
| Email |
sandeepparwal1983@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Of Ophthalmology, SMS Medical College and Hospital, Jaipur(302004), Rajasthan, India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College and Hospital |
| Address |
Department Of Ophthalmology, SMS Medical College and Hospital, Jaipur(302004), Rajasthan, India |
| 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 Sunil Kumar Gurjar |
SMS Medical College and Hospital |
Department Of Ophthalmology and Paediatrics, SMS Medical College and Hospital, Jaipur(302004), Rajasthan, India
Jaipur
RAJASTHAN |
9414137394
sunil.gurjar.9887@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMS Medical college and hospital |
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
|
| Type |
Name |
Details |
| Intervention |
nil |
none |
| Comparator Agent |
nil |
none |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
with gestational age at delivery of less than 30 weeks
birth weight of less than 1500 grams
considered to be under risk in terms of ROP by the neonatologist discretion (eg. infants with hypotension or those who received oxygen supplementation)
Whose legal parents agreed for the informed consent. |
|
| ExclusionCriteria |
| Details |
No final ROP outcome documentation.
Death before examination.
Loss to follow up. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To access the development and progression of ROP in thrombocytopenic participants. |
To access the development and progression of ROP in thrombocytopenic participants at 1st visit, 3 weeks, 6 weeks, 9 weeks and 12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
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)
|
25/05/2025 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
it is an observational study being conducted at SMS Medical college and Hospital,at department of ophthalmology and paediatrics to access the relationship between retinopathy of prematurity and thrombocytopenia. Patients will be recruited from neonatal ICU of pediatrics department and those coming to ophthalmology department for ROP screening. On first visit patients will classified into thrombocytopenic and non thrombocytopenic. after applying inclusion and exclusion criteria these patients will be followed up subsequently to see what proportion them develop ROP and will be divided into the ones requiring treatment and not requiring treatment. Also it will be noted how many of them change their category from ROP to No ROP and from requiring treatment to not requiring treatment. Examination will be done by using Indirect ophthalmoscope and panretinal 2.2 lens. |