| CTRI Number |
CTRI/2024/07/071416 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
25/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reach Out and Read Programme for Neurodevelopment in High risk babies of 1 year of age |
|
Scientific Title of Study
|
Effectiveness of Reach Out and Read Program on Neurodevelopment at 1 year in High risk infants A Randomized Controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ketaki Karnik |
| Designation |
Post graduate student |
| Affiliation |
KLE Institute of Physiotherapy Belgaum |
| Address |
Advanced Physiotherapy center, department of pediatric
physiotherapy room no 39, sagar floor, Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8450938733 |
| Fax |
|
| Email |
ketaki2209@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vinuta Deshpande |
| Designation |
Assistant Professor |
| Affiliation |
KLE Institute of Physiotherapy Belgaum |
| Address |
Advanced Physiotherapy center, department of pediatric
physiotherapy room no 39, sagar floor, Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8754466612 |
| Fax |
|
| Email |
vinuta.gangavatikar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ketaki Karnik |
| Designation |
Post graduate student |
| Affiliation |
KLE Institute of Physiotherapy Belgaum |
| Address |
Advanced Physiotherapy center, department of pediatric
physiotherapy room no 39, sagar floor, Belgaum Karnataka
Belgaum
KARNATAKA
590010
India |
| Phone |
8450938733 |
| Fax |
|
| Email |
ketaki2209@gmail.com |
|
|
Source of Monetary or Material Support
|
| KLE Dr Prabhakar Kore Hospital and Research center, Nehru Nagar, Belgaum 590010, Karnataka,India |
|
|
Primary Sponsor
|
| Name |
Ketaki Karnik |
| Address |
Advanced Physiotherapy center, department of pediatric
physiotherapy room no 39, sagar floor, Belgaum
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 Ketaki Karnik |
KAHER institute of physiotherapy |
Advanced Physiotherapy center, department of pediatric
physiotherapy room no 39, sagar floor, Belgaum Karnataka
Belgaum
KARNATAKA |
8450938733
ketaki2209@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 |
infants coming to high risk |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Reach Out and Read Program |
parents of infants visiting high risk clinic will be given
age-appropriate books in their
vernacular language and will be taught how to perform the task at their visit to high risk clinic at 6 months of age and will be followed at 8 and 10 months of age where new age appropriate books will be given |
| Comparator Agent |
Standard education |
parents will be explained
importance of neurodevelopment and will be guided on how to achieve it the intervention will continue for 6 months and at the third visit post assessment evaluation will
be taken |
|
|
Inclusion Criteria
|
| Age From |
6.00 Month(s) |
| Age To |
12.00 Month(s) |
| Gender |
Both |
| Details |
1. Male and female Infants who visit the High Risk clinic, at tertiary care hospital, Belagavi
2. Infants whose mothers are able to read and comprehend in vernacular language
3. Parents who are willing to participate
|
|
| ExclusionCriteria |
| Details |
1. Infants who are critically ill.
2. Infants who are referred for any surgeries in next 6 months.
3. Infant with genetic disorders, congenital anomalies, metabolic diseases
4. Infants with known neuromotor disabilities
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bayley Scales of Infant and Toddler Development - IV |
T0 at baseline at 6 months of age
T1 at 8 months of age
T2 at 10 months of age
T3 post assessment at 12 months of age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="34" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
12/08/2024 |
| Date of Study Completion (India) |
25/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study, titled "Effectiveness of Reach Out and Read program on Neurodevelopment at 1 year in High-risk Infants: A Randomized Controlled Trial," aims to evaluate the impact of the Reach Out and Read (ROR) program on the neurodevelopment of high-risk infants at one year of age. The ROR program is an early literacy intervention designed to promote early language and cognitive development through parent-child reading activities. This study aims to determine the effectiveness of the Reach Out and Read programme
on Neurodevelopment at 1 year in high risk infants. The hypothesis is that high-risk infants who participate in the ROR program will demonstrate better neurodevelopmental outcomes at one year of age, as measured by the Bayley Scales of Infant and Toddler Development-IV (BSID-4) or the Oxford Neurodevelopment Assessment (OX-NDA), compared to those who do not receive the intervention. |