| CTRI Number |
CTRI/2025/02/081483 [Registered on: 28/02/2025] Trial Registered Prospectively |
| Last Modified On: |
29/01/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Developing and Evaluating a Early Stimulation Program to Support the Development of Preterm Babies in the Neonatal Intensive Care Unit |
|
Scientific Title of Study
|
Development, Validation and Feasibility testing of Multimodal Early Stimulation Program for Preterm Infants in Neonatal Intensive Care Unit |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Abishek J R |
| Designation |
PhD Scholar |
| 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
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338789297 |
| Fax |
|
| Email |
aj7811@srmist.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Abishek J R |
| Designation |
PhD Scholar |
| 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
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338789297 |
| Fax |
|
| Email |
aj7811@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Abishek J R |
| Designation |
PhD Scholar |
| 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
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
7338789297 |
| Fax |
|
| Email |
aj7811@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM College of Physiotherapy,
SRM Medical College Hospital and Research Centre,
SRM Institute of Science and Technology |
|
|
Primary Sponsor
|
| Name |
NA |
| Address |
NA |
| Type of Sponsor |
Other [NA] |
|
|
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 and Research Centre,
SRM Institute of Science and Technology,
Kattankulathur,
Chengalpattu
Kancheepuram
TAMIL NADU |
9841298555
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 |
| Intervention |
Multimodal Early Stimulation Program |
Includes a week specific structured interventions that include nesting, positioning, kangaroo mother care, oromotor stimulation, respiratory proprioceptive neuromuscular facilitation, olfactory stimulation, massage, passive movements, gustatory stimulation, visual stimulation, reflex locomotion therapy and auditory stimulation.
The stimulation will be given from 26 weeks of corrected gestational age to 40 weeks of corrected gestational age.
In the desk review phase of the study and in the Delphi survey, a structured protocol with time duration and intensity and dosage will be finalised |
| Comparator Agent |
NA |
NA |
|
|
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 |
| Feasibility of Multimodal Early Stimulation Program (Adherence rate, acceptance rate, attrition rate, clinical fidelity, ease of performance, deviations from the protocol and adverse events) |
Every 7th day. From enrollment to discharge
Baseline and endline will be taken |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Content Validity of the developed protocol (Multimodal Early Stimulation Program) |
2 weeks |
|
|
Target Sample Size
|
Total Sample Size="38"
Sample Size from India="38"
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 |
|
Date of First Enrollment (India)
|
27/03/2025 |
| 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 commence recruiting preterm infants once a panel of experts validates the developed protocol to ensure it is safe to be implemented on the babies. This study will evaluate the feasibility of applying a gestational week-specific comprehensive early stimulation protocol in real-world settings, especially in low and middle-income countries. The findings of this study will help in designing future randomised control trials ensuring quality care |