| CTRI Number |
CTRI/2023/10/059036 [Registered on: 23/10/2023] Trial Registered Prospectively |
| Last Modified On: |
29/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
SENSES AND MOVEMENT ON CHILD DEVELOPMENT AMONG NEWBORN CHILDREN ADMITTED TO HOSPITAL. |
|
Scientific Title of Study
|
MULTIMODAL STIMULATION ON NEUROMOTOR DEVELOPMENT AMONG MODERATE TO LATE PRETERM NEONATES IN LEVEL 3 NEONATAL INTENSIVE CARE UNIT |
| Trial Acronym |
MMS - Multi-Modal Stimulation |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayshath Faiza |
| Designation |
post graduate student |
| Affiliation |
Physiotherapy Post Graduate Student |
| Address |
D/o Shafi Kalathur House Jaram
Post Ichilampady
Kasaragod Kerala
Yenepoya Physiotherapy Collage Kinya Derlakatte Mangalore Karnataka
Kasaragod
KERALA
647321
India |
| Phone |
6238149990 |
| Fax |
|
| Email |
ayshathfaiza1351999@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Asir John Samuel |
| Designation |
Additional Professor |
| Affiliation |
associate professor YPC |
| Address |
Yenepoya Physiotherapy Collage Yenepoya DEEMED to be university
Naringana
mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8059930222 |
| Fax |
|
| Email |
asirjohnsamuel@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Asir John Samuel |
| Designation |
Additional Professor |
| Affiliation |
Associate Professor YPC |
| Address |
Yenepoya Physiotherapy Collage Yenepoya DEEMED to be university
Naringana
mangalore
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8059930222 |
| Fax |
|
| Email |
asirjohnsamuel@yenepoya.edu.in |
|
|
Source of Monetary or Material Support
|
| yenepoya medical collage hospital derlakatte mangfalore |
|
|
Primary Sponsor
|
| Name |
Ayshath Faiza |
| Address |
post graduare student at yenepoya physiotherapy collage kinya derlakatte mangalore karnataka |
| Type of Sponsor |
Other [self ] |
|
|
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 |
| Ayshath Faiza |
Yenepoya Medical Collage Hospital |
neonatal intensive care unit
3rd floor
A WING
Derlakatte
Mangalore
Dakshina Kannada
KARNATAKA |
6238149990
ayshathfaiza1351999@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| yenepoya ethical committee |
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 stimuation |
multy sensory and motor stimulation |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
2.00 Day(s) |
| Age To |
7.00 Day(s) |
| Gender |
Both |
| Details |
preterm neonates of of either gender
gestational age 32-37 weeks
birth weight greater than 1000g |
|
| ExclusionCriteria |
| Details |
congenital malformation
seizure disorder
intraventricular hemorrhage
periventricular leukomalacia
high risk babies who require ventilation
septic condition |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| INFANIB, PREMIE NEURO |
2 points (pre and post) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| INFANIB, PREMIE NEURO |
a day before discharge |
|
|
Target Sample Size
|
Total Sample Size="16"
Sample Size from India="16"
Final Enrollment numbers achieved (Total)= "16"
Final Enrollment numbers achieved (India)="16" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/11/2023 |
| Date of Study Completion (India) |
29/07/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
29/07/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="5" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
Pre-term neonates are more prone to developmental delay and also other complications. This study is being conducted to determine the effect of multi-sensory stimulations on neuromotor development among moderate to late preterm neonates admitted in the NICU. Total 16 moderate to late preterm neonates admitted in NICU will be recruited for this study. The intervention will be given for 5 consecutive days following the admission and till discharge. Participants will receive multisensory and motor stimulation along with routine NICU care. The infant neurological international battery and premie neuro scales will be used for assessing neuromotor development after 5 days of intervention. Relevant parametric or non parametric test will be used to analyze the data for all outcomes. |