| CTRI Number |
CTRI/2024/09/074216 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
23/09/2024 |
| 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
|
to see the effect of multiple type of sensory stimulation and yakson method of stimulation in pre maturly delivered babies |
|
Scientific Title of Study
|
EFFECTIVENESS OF MULTISENSORY STIMULATION VERSUS YAKSON STIMULATION ON NEURO-BEHAVIOR AND WEIGHT GAIN IN PRETERM INFANTS : A COMPARATIVE STUDY |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 17855 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jigisha vaniya |
| Designation |
Assistant Professor |
| Affiliation |
parul sevashram hospital |
| Address |
OPD no 232 2nd floor parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india
Vadodara
GUJARAT
391760
India |
| Phone |
8200070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prasad Muley |
| Designation |
Associate Professor |
| Affiliation |
parul sevashram hospital |
| Address |
room no 232 floor no 2 parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india
Vadodara
GUJARAT
391760
India |
| Phone |
9879609195 |
| Fax |
|
| Email |
muleyprasad123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jigisha vaniya |
| Designation |
Assistant Professor |
| Affiliation |
parul sevashram hospital |
| Address |
OPD no 232 2nd floor parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india
Vadodara
GUJARAT
391760
India |
| Phone |
8200070593 |
| Fax |
|
| Email |
jigishavaniya95@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD no 232 2nd floor parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india, 391760 |
|
|
Primary Sponsor
|
| Name |
Parul Sevashram Hospital |
| Address |
OPD no 232 2nd floor parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india, 391760 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
NIL |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jigisha Vaniya |
Parul sevashram hospital |
OPD no 232 2nd floor parul sevashram hospital parul university at po limda tal waghodia dist vadodara gujarat india
Vadodara
GUJARAT |
8200070593
391760
jigishavaniya95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Parul university - IECHR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Multisensory stimulation |
5 days in a week for 4 weeks
1 hour per session
Follow up will be taken after 3 months. |
| Comparator Agent |
Yakson stimulation |
5 days in a week for four weeks.
1 hour per session
Follow up will be taken after 3 months. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
1.00 Month(s) |
| Gender |
Both |
| Details |
1)Preterm infants between 32 weeks – 37 weeks
2)Preterm infants whose birth weight is less than 2.5kgs/2500gms
3)Babies who are hemodynamically stable
4)Infants with both the genders will be included for the study
5)Babies receiving full enteral feeds.
|
|
| ExclusionCriteria |
| Details |
1)Major congenital anomalies
2)Inability to undergo intervention (any fracture) or perinatal asphyxia
3)Term neonates with low birth weight
4)Full term neonates with normal birth weight
5)Any chromosomal or other genetic abnormalities
6)Undergone any surgery
7)Neonates on ventilators will be excluded.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ANDERSON BEHAVIORAL STATE SCALE (ABSS) |
4 days a week for 4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| CALIBRATED DIGITAL WEIGHTING MACHINE |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="126"
Sample Size from India="126"
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)
|
07/10/2024 |
| 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="0"
Months="6"
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
|
AIM: To Assess and compare the Effect of Multisensory Stimulation Versus Yakson Stimulation on Neuro-Behavior and Weight Gain in Preterm Infants with Low Birth Weights.INTRODUCTION:The present scenario is that early intervention services for
children with developmental delays are far too scattered and the existing Early
Intervention services units are concentrated in the urban areas and hence they
hardly reach the target population. Therefore, special focus is required to
address the existing deficiencies in providing early intervention services.The preterm newborn moves to smaller degrees as compared to full‑term
newborns.In high‑risk prenatal neonates, there are increased chances of
appearance of development impairments at later stage of development.Stimulation given at an early stage to neonates can alter the growth
of the brain cells, improve adaptive behavior, and thus, age‑appropriate
development is likely to be achieved.Hence this study will help to incorporate a new and advanced
treatment of preterm neonates as a part of early intervention.Multisensory stimulation consists of Auditory stimulation, Tactile
stimulation, Visual stimulation and Vestibular stimulation (ATVV).Pre term birth rate with low birth weight and preterm delivery is
one of the quickly rising problems in modern society. NEED OF STUDY :Several studies have proven that physiotherapy is much
effective in infants with low birth weight and pre term delivery and also
various approaches has been developed in recent years to treat and rehabilitate
such infants. Majority of this approaches are time consuming and not many
comparisons have been made for such approaches. Studies assessing the effect of Multisensory stimulation on
pre term low birth weight infants have been conducted and statistical results
on its effect have been established. Similarly, we have articles and research studies which also
prove the effect of one of the recent approaches i.e., Yakson Stimulation. But the
is a scarcity of research studies comparing the effect of Multisensory
stimulation and Yakson Stimulation among pre term low birth weight infants. Hence the purpose of current study is to Assess and compare the Effect of
Multisensory Stimulation Versus Yakson Stimulation on Neuro-Behavior and Weight
Gain in Preterm Infants with Low Birth Weights. PROCEDURE: After taking approval from CTRI and ethical committe informed concent will be taken from the parents of infants and pre assessment will be done according to inclusion criteria. participants will be divided into two equal groups.Group A will recieve Multisensory stimulation for four weeks. Group B will recieve yakson stimulation for four weeks.follow up will be taken after 3 months for both groups.conclusion of the study will be made after statistical analysis.
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