| CTRI Number |
CTRI/2024/07/071674 [Registered on: 31/07/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Effectiveness of the SAFEÂ early intervention approach on brain development in premature babies with abnormal fidgety movements |
|
Scientific Title of Study
|
Effectiveness Of The SAFE Early Intervention Approach On Neurodevelopment In Preterm Infants With Abnormal Fidgety Movements: 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 |
Shruti Desai |
| 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 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9028427280 |
| Fax |
|
| Email |
shrutidesai0404@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Deepa Metgud |
| Designation |
Professor and HOD of Pediatric Physiotherapy |
| Affiliation |
KAHER Institute of Physiotherapy |
| Address |
Advanced Physiotherapy center, room no 39, sagar floor, KLE Dr
prabhakar kore Hospital Belgaum Karnataka 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9845861236 |
| Fax |
|
| Email |
drdeepa_metgud@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Desai |
| 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 590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9028427280 |
| Fax |
|
| Email |
shrutidesai0404@gmail.com |
|
|
Source of Monetary or Material Support
|
| High Risk Baby Clinic, Tertiary care hospital, Belagavi, Karnataka, India, 590010 |
|
|
Primary Sponsor
|
| Name |
Shruti Desai |
| Address |
Sagar Floor, Advanced Physiotherapy Centre, Room no 39, KLE
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 |
| Shruti Desai |
KAHER institute of physiotherapy |
Advanced
Physiotherapy center,
room no 39, sagar floor,
KLE Dr prabhakar kore
Hospital Belgaum
Karnataka India 590010
Belgaum
KARNATAKA |
9028427280
shrutidesai0404@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research and Ethical Comittee KAHER Institute of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
health individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NDT |
A NDT-based home program will be given to the infants in the control group according to their corrected ages and current functional levels. Families will be asked to do this activities for 45 min, per day for 10 weeks. |
| Intervention |
SAFE Approach |
SAFE approach is an early intervention family-centered approaches that focuses on activity-based motor training and sensory strategies in an enriched environment. Age appropriate activities within the scope of the SAFE approach will be explained to the families, and demos will be given to make sure that they have learned them. Families will be asked to do this activities for 45 min, per day for 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Month(s) |
| Age To |
3.00 Month(s) |
| Gender |
Both |
| Details |
Male and female infants born before 37 weeks of gestational age.
Infants between 2 months - 3 months (2 months 0 days- 2 months 30 days) of corrected age.
Preterm infants having abnormal fidgety movements.
Willingness of family members to participate in this study.
Score less than 10 on Edinburgh postnatal depression scale. |
|
| ExclusionCriteria |
| Details |
Having a history of congenital anomaly or systemic disease.
Medical conditions which prevent active participation in therapy (such as dependence on oxygen).
H/O Seizures. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| General Movement Assessment tool |
Baseline Screening |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Ages and Stages Questionnaire, Third Edition |
Baseline and Post intervention |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="40" |
|
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="1"
Months="0"
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
|
Objective: To evaluate the effectiveness of SAFE early intervention on Neurodevelopment in preterm infants with abnormal fidgety movements using the Ages and Stages Questionnaire-3 (ASQ-3). Inclusion: Male and female infants born before 37 weeks of gestational age; between 2-3 months of age; with abnormal fidgety movements
Exclusion: Having a history of congenital anomaly or systemic disease; Dependence on oxygen; h/o seizures.
|