| CTRI Number |
CTRI/2011/04/001703 [Registered on: 27/04/2011] Trial Registered Retrospectively |
| Last Modified On: |
06/04/2011 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of sensory system stimulation on the development of premature babies |
|
Scientific Title of Study
|
Effect of hospital based multisensory stimulation on neuromotor development in preterm infants |
| Trial Acronym |
RCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Parimala suganthiniK |
| Designation |
PG student |
| Affiliation |
|
| Address |
Department of physiotherapy,
2nd floor
Manipal College Of Allied Health Sciences
12 sannathi street
lalgudi
Trichy
tamilnadu
Not Applicable
N/A
576104
India |
| Phone |
08202922376 |
| Fax |
|
| Email |
pari.suganthini@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhamini k rao |
| Designation |
Associate professor |
| Affiliation |
|
| Address |
Department of physiotherapy
2nd floor
Manipal college of allied health sciences
Udupi
KARNATAKA
576104
India |
| Phone |
08202922376 |
| Fax |
|
| Email |
bhaminikr@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Divya Mohan |
| Designation |
assisstant professor |
| Affiliation |
|
| Address |
Department of Physiotherapy
2nd floor
Manipal college of allied health sciences
Udupi
KARNATAKA
576104
India |
| Phone |
08202922376 |
| Fax |
|
| Email |
dimspt2002@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy,
Manipal college of allied health sciences,Manipal, Karnataka |
|
|
Primary Sponsor
|
| Name |
MrsBhaminiK Rao |
| Address |
Associate professor,
Department of physiotherapy
2nd floor
Manipal college of allied health sciences
Manipal,Karnataka |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| MsDivya Mohan |
Assistant Professor
department of physiotherapy
2nd floor
Manipal College of Allied health Sciences
Manipal, Karnataka
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhamini K Rao |
Neonatal intensive care unit |
Neonatal intensive care unit
Kasturba hospital
Manipal
Udupi
KARNATAKA |
08202922376
bhaminikr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Manipal University ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Preterm infants, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
multisensory stimulation along with routine NICU care |
auditory, tactile, visual and vestibular stimulation for 3 mins each |
| Comparator Agent |
Routine NICU care |
kangaroo mother care ,positioning |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
56.00 Day(s) |
| Gender |
Both |
| Details |
Infants born between 28- 36 weeks of gestation with birth weight more than 1000 grams |
|
| ExclusionCriteria |
| Details |
Preterms who are medically unstable, infants on ventilator support, with congenital anomalies and diagnosed central nervous system injury |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Infant Neurological International Battery (INFANIB) |
At discharge from hospital at follow up of 3 months and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Frequency of physiological stress sign(heartrate above 200 or below 100 bpm,respiratory rate greater than 20 from baseline,oxygen saturation below 86 percent) and behavioral sress sings |
Baseline 0-5 minutes, during Intervention (12 minutes)
Recovery 5 minutes |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
06/02/2010 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomized, two group post test design to find the effect of various sensory stimulation on the neuromotor development of preterm infants. the primary outcome is the infant neurological international battery taken at discharge from hospital. the infants will be follwed up at 3 months and 6 months of corrected gestational age. |