| CTRI Number |
CTRI/2023/11/060222 [Registered on: 23/11/2023] Trial Registered Prospectively |
| Last Modified On: |
22/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of baby development who got discharged from NICU |
|
Scientific Title of Study
|
Assessment of motor development in infants discharged from NICU |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khushboo kumari |
| Designation |
PG Student |
| Affiliation |
College Of Physiotherapy, Sumandeep Vidyapeeth, An Institution Deemed To Be University |
| Address |
PG Classroom, On Ground Floor,College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be
University, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9334053055 |
| Fax |
|
| Email |
khushbookumari8981@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate professor |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY SUMANDEEP VIDYAPEETH AN INSTITUTION DEEMED TO BE UNIVERSITY |
| Address |
Staffroom On ground floor, College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be
University, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dhwani Chanpura |
| Designation |
Associate professor |
| Affiliation |
COLLEGE OF PHYSIOTHERAPY SUMANDEEP VIDYAPEETH AN INSTITUTION DEEMED TO BE UNIVERSITY |
| Address |
Staffroom On ground floor,College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be
Univeristy, Piparia, Waghodia, Vadodara, 391760
Vadodara
GUJARAT
391760
India
Vadodara
GUJARAT
391760
India |
| Phone |
9974704464 |
| Fax |
|
| Email |
dhwani.cop@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
|
This is a self funded study and the study will be conducted in Dhiraj general hospital. The infrastructure is provided by College Of Physiotherapy,
Sumandeep Vidyapeeth, An Institutional Deemed to be University Vadodara Gujara |
|
|
Primary Sponsor
|
| Name |
Khushboo kumari |
| Address |
College of Physiotherapy, Sumandeep Vidyapeeth Deemed to be
Univeristy, Piparia, Waghodia, Vadodara, 391760
|
| Type of Sponsor |
Other [self funded] |
|
|
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 Khushboo kumari |
Dhiraj General Hospital |
OPD (number 9,10), on ground floor, Dhiraj General Hospital
Sumandeep Vidyapeeth
Pipariya Vadodara
Vadodara
GUJARAT
Vadodara
GUJARAT |
9334053055
khushbookumari8981@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
0.00 Day(s) |
| Age To |
2.00 Year(s) |
| Gender |
Both |
| Details |
1. Infants parents who are willing to participate.
2. Infants who has history of NICU admission at least for 1 week.
3. Infants Discharged from NICU of 0-2 years. |
|
| ExclusionCriteria |
| Details |
1. Infants who were clinically unwell and requires any respiratory support beyond 72 hours of life.
2. Infants born less than 30 weeks of gestation.
3. Infants born with congenital abnormalities or chromosomal anomalies.
4. Any known Neurological, Musculoskeletal conditions and cardio respiratory |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Movement assessment of infant (MAI) |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Child weight and developmental milestone |
1 time |
|
|
Target Sample Size
|
Total Sample Size="41"
Sample Size from India="41"
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)
|
30/11/2023 |
| 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 Applicable |
| 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
|
This is the cross sectional study. After CTRI registration, infants who born after 30 week of gestational age, had history of NICU
admission atleast for 1 week and who fulfil the inclusion criteria will be approached for study. Prior to the assessment In details explanation will be given to parents about the study, Those who
are willing to participate in the study, informed consent form for parents of infants will be obtained from them, Participation parents information sheet will be given to all parents
explaining the details of the study . All the infants meeting the inclusion criteria will be recruited for the study and the basic details of
the infant will be collected according to assessment sheet. After that all the infants
will be assessed with the help of movement assessment of infants’ scale as per the age of child. Therefore the purpose of the study is to determine whether a very preterm infant is developing normally or abnormally, assess the
effects of interventions and exposure to perinatal variables, and predict whether the infant
may have long term developmental problems, so that appropriate interventions can be
commenced immediately. |