| CTRI Number |
CTRI/2023/11/060267 [Registered on: 28/11/2023] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [MULTI SENSORY STIMULATION WITH PIOMI] |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
To measure effectiveness of activation of multiple senses in premature babies on physical growth and oral feeding improvement |
|
Scientific Title of Study
|
Effectiveness of multi-sensory stimulation on physiological
stability and oral motor development among preterm
infants admitted 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 |
AMRITA A SIVSANKER |
| Designation |
PhD scholar |
| Affiliation |
SHARDA UNIVERSITY |
| Address |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH, BLOCK 4, GROUND FLOOR, ROOM NO.007, SHARDA UNIVERSITY, GREATER NOIDA, UTTAR PARDESH
Gautam Buddha Nagar
UTTAR PRADESH
201310
India |
| Phone |
9910023198 |
| Fax |
|
| Email |
amrita.akhilesh@sharda.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR UPPU PRAVEEN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH, SHARDA UNIVERSITY |
| Address |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH,BLOCK 4, ROOM NO.007, GROUND FLOOR, SHARDA UNIVERSITY
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
720428697 |
| Fax |
|
| Email |
uppu.praveen@sharda.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
DR UPPU PRAVEEN |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH, SHARDA UNIVERSITY |
| Address |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH, BLOCK 4, ROOM NO.007, GROUND FLOOR, SHARDA UNIVERSITY, KNOWLEDGE PARK -III
Gautam Buddha Nagar
UTTAR PRADESH
201306
India |
| Phone |
720428697 |
| Fax |
|
| Email |
uppu.praveen@sharda.ac.in |
|
|
Source of Monetary or Material Support
|
| SHARDA HOSPITAL AND MEDICAL RESEARCH CENTRE, SHARDA UNIVERSITY, KNOWLEDGE PARK -III, GREATER NOIDA, UTTAR PRADESH |
|
|
Primary Sponsor
|
| Name |
AMRITA A SIVASANKER |
| Address |
SHARDA SCHOOL OF NURSING SCIENCE AND RESEARCH, SHARDA UNIVERSITY |
| 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 |
| AMRITA AKHILESH SIVASANKER |
SHARDA HOSPITAL |
SHARDA UNIVERSITY, KNOWLEDGE PARK -3, GREATER NOIDA
Gautam Buddha Nagar
UTTAR PRADESH |
9910023198
amrita.akhilesh@sharda.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE, SCHOOL OF MEDICAL SCIENCES RESEARCH, SHARDA UNIVERSITY |
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 |
Preterm infant multi sensory stimulation (PIMS) |
Sensory stimulation (Auditory stimulation, Visual stimulation, Tactile stimulation, Oral stimulation) and motor stimulation (Kinesthetic stimulation) for 15 minutes duration 6 days in a week two times (Morning and Evening) 1 hour before scheduled NG tube feeding |
| Comparator Agent |
Routine care |
Breast feeding and Nursing care provided at the hospital |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
Medically and hemodynamically stable
Having gestational age of 28 to 36 weeks
More than 36 hours of birth
Staying in the NICU for not less than 6 days
Mothers willing to participate
Mothers who can understand and able to re-demonstrate maternal oral sensory and motor stimulation skills.
|
|
| ExclusionCriteria |
| Details |
Having any complications and on treatment |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| PHYSIOLOGICAL STABILITY AND ORAL MOTOR STIMULATION |
AT BASELINE, 1 WEEK, 2 WEEKS |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2023 |
| 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
Modification(s)
|
Infants born with low birth weight is the leading factor in neonatal mortality in the world. These infants faces a lot of problems like sensory-neurological disorders, palsies, cognitive and speech delays, neuromotor, visual impairment, behavioral problems and school dysfunction. These critical decisions to rule out the exact cause of death rely on the collected data on maternal risk, obstetrical factors, history collected at admission and documentation of clinical events.
To improve developmental outcomes in preterm infants specific interventions are designed for preterm babies admitted in NICU. Multi sensory intervention to stimulate the babies is a relatively new intervention that closely resembles the principles of evolutionary care. In order to stimulate and facilitate the development of the preterm babies there are many types of multi-sensory stimulation have been proposed since 1960 specially designed for preterm babies admitted in the hospital. This trial also include the pilot study. |