| CTRI Number |
CTRI/2024/03/063545 [Registered on: 04/03/2024] Trial Registered Prospectively |
| Last Modified On: |
01/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assess muscle tone in extremely preterm, very preterm and moderate preterm infants at 40 weeks of corrected gestational age. |
|
Scientific Title of Study
|
Assessment of muscle tone in extremely preterm, very preterm and moderate preterm infants at 40 weeks of corrected gestational age |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S PRIYANGA |
| Designation |
MPT STUDENT |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DEEMED TO BE UNIVERSITY) |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
7598414814 |
| Fax |
|
| Email |
priyaseemathan@gail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M RAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DEEMED TO BE UNIVERSITY) |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M RAJESWARI |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH (DEEMED TO BE UNIVERSITY) |
| Address |
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswari@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research (Deemed to be University), No.1 Ramachandra Nagar, Porur, Chennai-600116 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NO SPONSOR] |
|
|
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 |
| S PRIYANGA |
SRI RAMACHANDRA INSTITUTE OF HIGHER EDUCATION AND RESEARCH |
Neonatal Intensive Care Unit-Sri Ramachandra Hospital NO-1, Mount Poonamallee Rd, Sri Ramachandra Nagar, Ramachandra Nager, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU |
7598414814
priyaseemathan@gail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE FOR STUDENTS PROJECTS DHR/ICMR REG NO: EC/NEW/INST/2023/TN/0321 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
preterm infants
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
1.00 Month(s) |
| Age To |
2.00 Month(s) |
| Gender |
Both |
| Details |
1.Preterm infants born at different gestational ages (extreme, very, moderate to late preterm infants).
2. Preterm infants of both the gender.
3. Infants with normal USD cranium findings |
|
| ExclusionCriteria |
| Details |
1. Infants whose vitals are unstable.
2. Infants with musculoskeletal/ neurological disorders.
3. Infants with any genetic disorder. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| AMIEL-TISON ANGLE TO MEASURE MUSCLE TONE |
After birth when the vitals are stable and at 40th week of gestational age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="102"
Sample Size from India="102"
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)
|
11/03/2024 |
| 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="5"
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
|
Children born very prematurely can be expected to differ from healthy full-term babies in many aspects of their development. As the preterm infant is born before the complete development of muscle tone they have maturation related hypotonia. The amount of muscle tonal development in extrauterine life is different in preterm infants born at different gestational age. Many programs have been targeted in providing good stimulation for the neurodevelopment of the infant. External environment places a different demand in the development of muscle tone of children born at different gestational age. So, this tone changes during the different gestational age is being assessed at the 40th week of corrected age. In this study Preterm infants will be selected based on the inclusion criteria from NICU in Sri Ramachandra hospital. Based on the gestational age infants will be grouped into group I, II, and III. Tone of the infants will be measured using AT angle after birth when the infant’s vitals are stable and all the infants will receive early stimulation program till the 40th week of corrected gestational age. In AT angles used for measurement were the adductor angle, heel to ear and popliteal angle, dorsiflexion angle and scarf sign. The same assessment will be repeated at 40th week of CGA. |