| CTRI Number |
CTRI/2021/03/031880 [Registered on: 10/03/2021] Trial Registered Prospectively |
| Last Modified On: |
13/02/2021 |
| 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 Oral Motor Muscle Stimulation on health outcomes of Preterm Infants |
|
Scientific Title of Study
|
Effect of Oral Motor Muscle Stimulation on outcomes of Preterm Infants |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
RAJ K MOTGHARE |
| Designation |
Nursing Officer |
| Affiliation |
GOVERNMENT MEDICAL COLLEGE AND HOSPITAL NAGPUR |
| Address |
Plot no 221 Mahatma Gandhi Nagar Hudkeshwar Road Nagpur
Neonatal Intensive Care Unit infront of ward no 50 ground floor Govt Medical College and Hospital Nagpur
Nagpur
MAHARASHTRA
440034
India |
| Phone |
09503541906 |
| Fax |
|
| Email |
rajmotzngp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Archana Mourya |
| Designation |
Professor & HOD |
| Affiliation |
Datta Meghe Institute of Medical Sciences Deemed University NAGPUR |
| Address |
Department of Child Health Nursing SRMM College of Nursing Sawangi Meghe Wardha
Jawaharlal Nehru Medical College Sawangi Meghe Wardha
Wardha
MAHARASHTRA
442001
India |
| Phone |
9422903004 |
| Fax |
|
| Email |
archanatej95@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
RAJ K MOTGHARE |
| Designation |
Nursing Officer |
| Affiliation |
Government Medical College and Hospital Nagpur |
| Address |
Plot no 221 Mahatma Gandhi Nagar Hudkeshwar Road Nagpur
Neonatal Intensive Care Unit ground floor infront of ward 50 govt medical college and hospital Nagpur
Nagpur
MAHARASHTRA
440034
India |
| Phone |
09503541906 |
| Fax |
|
| Email |
rajmotzngp@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raj K Motghare |
| Address |
221 Mahatma Gandhi Nagar Hudkeshwar Road Nagpur |
| Type of Sponsor |
Other [SELF] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Archana Mourya |
AVBR Hospital Sawangi Meghe Wardha |
NICU AVBR Hospital Sawangi Meghe Wardha
Wardha
MAHARASHTRA |
9422903004
archanatej95@gmail.com |
| Raj Motghare |
Govt Medical College and Hospital Nagpur |
NICU, Ground floor infront of ward 50 Govt Medical College and Hospital Nagpur
Nagpur
MAHARASHTRA |
09503541906
rajmotzngp@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| DMIMS DU NAGPUR |
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 |
Oral Motor Muscle Stimulation |
5 steps performed before feeding
For 5 minutes upto 7 days at least first three days once a day then twice a day |
| Comparator Agent |
Routine practices |
Performed in NICU
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
10.00 Day(s) |
| Gender |
Both |
| Details |
1 admitted in NICU
2 parents willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Prematurity with ventilatory support
Prematurity with VLBW
Prematurity with congenital Anamolies |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Improve physiological signals
Improved growth parameters
Transition to active breastfeed |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Reduction in hospital stay
Improved excretory function
Overall weight gain |
10 days |
|
|
Target Sample Size
|
Total Sample Size="112"
Sample Size from India="112"
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)
|
01/04/2021 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is done as the fulfillment of a Ph.D. Thesis to assess the effectiveness of oral motor muscle stimulation on outcomes of preterm infants aims- 1.to enhance breastfeeding 2. to decrease the hospital stay. 3. improve physiological signals 4. overall improvements |