| CTRI Number |
CTRI/2024/03/064061 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Multisensory stimulation technique for preterm infants in improving neurobehavioral response and wei0ght gain |
|
Scientific Title of Study
|
Effect of multisensory stimulation on neurobehavioral response and weight gain in preterm infants |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayisha Nazarin T |
| Designation |
MPT Paediatrics Student |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences, Department of physiotherapy, Pediatrics division, Room no 4016
#395 Sarojini Naidu Road Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8825899060 |
| Fax |
|
| Email |
ayishanazarinnlc@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Senthil Kumar A |
| Designation |
MPT Paediatrics |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences, Department of physiotherapy, Pediatrics division, Room no 4016
#395 Sarojini Naidu Road Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
9944182647 |
| Fax |
|
| Email |
asenthilpt@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ayisha Nazarin T |
| Designation |
MPT Paediatrics Student |
| Affiliation |
Sri Ramakrishna Institute of Paramedical Sciences |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences, Department of physiotherapy, Pediatrics division, Room no 4016
#395 Sarojini Naidu Road Sidhapudur, Coimbatore
Coimbatore
TAMIL NADU
641044
India |
| Phone |
8825899060 |
| Fax |
|
| Email |
ayishanazarinnlc@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Ramakrishna Institute of Paramedical Sciences, Department of physiotherapy, Pediatrics division, Room no 4016
#395 Sarojini Naidu Road Sidhapudur, Coimbatore |
|
|
Primary Sponsor
|
| Name |
Ayisha Nazarin T |
| Address |
Sri Ramakrishna Institute of Paramedical Sciences, Department of physiotherapy, Pediatrics division, Room no 4016
#395 Sarojini Naidu Road Sidhapudur, Coimbatore |
| Type of Sponsor |
Other [Self ( Part Of Master Programme)] |
|
|
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 Siddartha Buddhavarapu |
Sri Ramakrishna Multi Specialty Hospital |
Sri Ramakrishna Institute of Paramedical Sciences, Department of Pediatrics, Room no 17
Coimbatore
TAMIL NADU |
9894329119
drsiddartha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRI RAMAKRISHNA HOSPITAL ETHICAL COMMITEE |
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 |
MULTISENSORY STIMULATION |
Tactile Stimulation, Vestibular stimulation, Kinesthetic stimulation,
Oral stimulation,
Auditory stimulation,
Visual stimulation
Intervention duration - 30 minutes per day for 3 weeks
Pre and Post test values will be calculated |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
Infants born at 32-36 weeks of gestational age
Gender both male and female are included
Weight 1300g – 1700g
APGAR score at 5 minutes scores above 6
Infants fed orally by gavage
Babies who were hemodynamically stable
Infants with normal visual and auditory status
Infants with written consent of their parent
|
|
| ExclusionCriteria |
| Details |
Congenital malformation
Genetic or metabolic diseases
Seizure disorder
CNS injuries
Severe asphyxia
High level of bilirubin
Respiratory diseases
Infants with the need for mechanical ventilation.
Infant who takes breastfeed.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Neurobehavioral Response and Weight Gain |
At baseline and after 3 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
18/03/2024 |
| 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="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [ayishanazarinnlc@gmail.com].
- For how long will this data be available start date provided 10-09-2024 and end date provided 10-09-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
EFFECT OF MULTISENSORY STIMULATION ON
NEUROBEHAVIORAL RESPONSE AND WEIGHT GAIN IN PRETERM INFANTS
ABSTRACT
INTRODUCTION:
Premature infants undergo a lot of stressful
procedures during care and treatment procedures, which may lead to weight
changes and a lack of sensory experiences that are vital for normal brain
development. They are also exposed to excessive or inappropriately timed
stimulation in the NICU that leads to deleterious effects on premature infants
whose brains are immaturely developed.
AIM:
This study aims to
evaluate multisensory stimulation in stimulating respective sensory receptors
for weight gain and neurobehavioral response in preterm infants.
METHOD:
The study will have two groups: control group received routine medical and
nursery care in the NICU whereas intervention group received the same programme
given to the control group in addition to multisensory stimulation programme
for a 45-minute daily session, for 3 consecutive weeks. Twenty preterm infants
admitted to the NICU who meet the inclusion criteria will be selected. Eligible
infants will be randomly assigned to one of the two groups, The outcomes are
neurobehavioral response and weight gain, which will be measured before and
after the intervention by a Morgan neonatal neurobehavioral examination and a
digital weighing scale, respectively.
RESULT:
Statistical analysis will be done after data
collection and conclusion will be drawn
KEY WORDS:
Preterm infants, Multisensory stimulation, Neurobehavior,
Weight gain |