| CTRI Number |
CTRI/2024/07/071457 [Registered on: 29/07/2024] Trial Registered Prospectively |
| Last Modified On: |
21/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing the Neurodevelopment of Children with Retinopathy of Prematurity in Belagavi city : An Observational study |
|
Scientific Title of Study
|
Neurodevelopment of Children with Retinopathy of Prematurity in Belagavi city: An Observational Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Siddhi Kadam |
| Designation |
Post Graduate student |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital, Belgaum, Karnataka
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital ,Belgaum ,Karnataka
KARNATAKA
590010
India
Belgaum
KARNATAKA
590010
India |
| Phone |
8689990295 |
| Fax |
|
| Email |
siddhik982@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital ,Belgaum Karnataka
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital , Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466613 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Siddhi Kadam |
| Designation |
Post Graduate student |
| Affiliation |
KAHER institute of physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital , Belgaum Karnataka
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr prabhakar kore Hospital , Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8689990295 |
| Fax |
|
| Email |
siddhik982@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar kore hospital and research center, Nehru nagar,belagavi 590010 Karnataka
|
|
|
Primary Sponsor
|
| Name |
Siddhi Kadam |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010
Dr.Prabhakar Kore Hospital and MRC, Belagavi,Karnataka, 590010 |
| Type of Sponsor |
Other [self sponsored ] |
|
|
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 Siddhi Kadam |
KAHER Institute of Physiotherapy |
Advanced
Physiotherapy center,
room no 39, sagar floor,
KLE Dr prabhakar kore
Hospital, Belgaum
Karnataka
Belgaum
KARNATAKA |
8689990295
siddhik982@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and ethical committee KAHER institute of physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Children with Retinopathy of Prematurity |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Month(s) |
| Age To |
3.11 Month(s) |
| Gender |
Both |
| Details |
Parents willing to participate in the study.
Children born between September 2021 and February 2022 , all gender, diagnosed with ROP.
|
|
| ExclusionCriteria |
| Details |
Children with congenital malformation, genetic conditions and having, or neurological problems associated with, and IVH .
Children with congenital malformations or genetic syndromes .
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Bayley Scales of Infant & Toddler Development
(BSID 4)
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| nil |
nil |
|
|
Target Sample Size
|
Total Sample Size="43"
Sample Size from India="43"
Final Enrollment numbers achieved (Total)= "43"
Final Enrollment numbers achieved (India)="43" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/08/2024 |
| Date of Study Completion (India) |
04/03/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
Modification(s)
|
Retinopathy of prematurity results from disrupted angiogenesis as a result of preterm birth and exposure to higher levels of oxygen postnatally than in utero .Globally, retinopathy of prematurity is common in both high income and low income countries, causing blindness or severe visual impairment in 20,000 to 30,000 children from 2000 to 2009. ROP is also linked to developmental delays, though this is less studied in low- and middle-income countries (LMICs).In India, retinopathy of prematurity prevalence ranges from 44% to 47.27%, with significant prenatal and postnatal risk factors. While most studies focus on retinopathy of prematurity prevalence and risk factors, there is limited research on its link to neurodevelopmental disorders . A Tamil Nadu study found that 68.4% of infants with retinopathy of prematurity had neurodevelopmental delays, highlighting the lack of awareness of this association in low- and middle-income countries.Hence the present study is intended to determine the neurodevelopment of children with ROP |