| CTRI Number |
CTRI/2025/11/097095 [Registered on: 07/11/2025] Trial Registered Prospectively |
| Last Modified On: |
28/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Testing Practicality and Acceptance of Early Stimulation Activities for Preterm Babies in Neonatal Intensive Care Units in Tamil Nadu |
|
Scientific Title of Study
|
Multimodal Early Stimulation for Preterm Infants Admitted in Neonatal Intensive Care Unit: A Pilot Feasibility Non-Randomized Trial In Tamil Nadu Context |
| 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 Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No.PT 16 SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
vadivelk@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No.PT 16 SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
vadivelk@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vadivelan Kanniappan |
| Designation |
Professor |
| Affiliation |
SRM College of Physiotherapy, SRM Institute of Science and Technology |
| Address |
Room No.PT 16 SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur, Chengalpattu
Kattankulathur
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
09841298555 |
| Fax |
|
| Email |
vadivelk@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy, SRM Institute of Science and Technology, Kattankulathur,
Chengalpattu. |
|
|
Primary Sponsor
|
| Name |
SRM Institute of Science and Technology |
| Address |
Kattankulathur, Chengalpattu, Tamil Nadu - 60302, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 K Vadivelan |
SRM Medical College Hospital and Research Centre |
Neonatal Intensive Care Unit, SRM Medical College Hospital andResearch Centre, SRM Institute of Science and Technology,Kattankulathur, Chengalpattu
Kancheepuram
TAMIL NADU |
09841298555
vadivelk@srmist.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: P073||Preterm [premature] newborn [other], |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Kangaroo Mother Care |
Kangaroo Mother Care in NICU |
| Intervention |
Multimodal Early Stimulation Program |
Includes a parent delivered gestational week specific multimodal; early stimulation program, that will be designed by triangulated the existing evidence and the practice patterns of therapists in NICU, which will further be content validated for safety and feasibility by a panel of experts in neonatal care |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
90.00 Day(s) |
| Gender |
Both |
| Details |
Preterm infants born between the gestational age of 26 weeks and 35 weeks
APGAR score greater than 7 at birth
Haemodynamically stable preterm infants |
|
| ExclusionCriteria |
| Details |
Congenital anomalies
Invasive ventilation
Parents not willing to participate in the study
Retinopathy of prematurity
Bone fracture
Intraventricular haemorrhage |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Primary Feasibility Outcomes:
• Recruitment and retention rates:
• Descriptive statistics, which include percentages, means, and medians will be applied to summarize recruitment rates, participant retention, and attrition.
• Therapy fidelity:
Calculate adherence rates to the intervention protocol and assess deviations using proportions and confidence intervals. |
The test for feasibility will be assessed at the time of admission, every week after that, till the point of discharge.
Retention rates will be assessed at the time of discharge
Recruitment rate will be assessed at the time of admission |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Neurodevelopmental Outcomes:
Analyze Premie-Neuro Scale scores for pre- and post-intervention data.
• Feeding Skills:
Apply the Early Feeding Skill Scale.
• Respiratory Status:
Silverman Anderson Scores for changes |
At the time of admission and at the time of discharge |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
10/11/2025 |
| 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
|
This study will evaluate the feasibility of applying a gestational week-specific comprehensive early stimulation protocol in settings, especially in low and middle-income countries with motherr a the primary care provider and it will also evaluate the efficacy of the developed protocol in improving neurodevelopmental outcomes. |