| CTRI Number |
CTRI/2025/03/083246 [Registered on: 24/03/2025] Trial Registered Prospectively |
| Last Modified On: |
21/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Muscle Tone and Motor Development in Preterm Babies at 8 Months Adjusted Age
|
|
Scientific Title of Study
|
Muscle Tone and motor development in extremely preterm, very preterm, moderate preterm Infant at 8 months of corrected 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 |
Karthick K |
| Designation |
MPT neurosciences |
| Affiliation |
Sri Ramachandra Institute of Higher Education and Research |
| Address |
Department of neuro sciences,1st floor,
faculty of physiotherapy
No.1, Ramachandra nagar,
Porur
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
6385875055 |
| Fax |
|
| Email |
Karthickkrishnamoorthy640@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
M Rajeswari |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra institute of Higher Education and Research |
| Address |
1st floor, Department of neurosciences,
Faculty of Physiotherapy
No.1, Ramachandra nagar,
Porur,
Chennai
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarim@sriramachandra.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
M Rajeswari |
| Designation |
Associate professor |
| Affiliation |
Sri Ramachandra institute of Higher Education and Research |
| Address |
1st floor,
Department of neurosciences,
Faculty of Physiotherapy
No.1, Ramachandra nagar,
Porur,
Chennai
TAMIL NADU
600116
India |
| Phone |
9841417473 |
| Fax |
|
| Email |
rajeswarim@sriramachandra.edu.in |
|
|
Source of Monetary or Material Support
|
| Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra nagar, porur
Chennai 600116
Tamil Nadu
India |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
Nil |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrKarthick |
Sri Ramachandra Institute of Higher Education and Research |
C2, 2nd floor, pediatric neurology
Medical centre
No.1, Ramachandra nagar
Porur
Chennai 600116
Chennai
TAMIL NADU |
6385875055
Karthickkrishnamoorthy640@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical committee, Sri Ramachandra Institute of Higher Education and Research |
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 |
| Comparator Agent |
NIL |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Month(s) |
| Age To |
9.00 Month(s) |
| Gender |
Both |
| Details |
1.Preterm infants born at different gestational ages (extreme, late and moderate preterm infants) at 8th month of corrected age.
2. Full-term infants at 8th month of age.
3. Preterm infants and Full-term infants of both the gender. |
|
| ExclusionCriteria |
| Details |
1.Infants with musculoskeletal, neurological, cardiopulmonary disorders and Genetic disorder.
2. Infants underwent surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Peabody Development Motor Scales (PDMS-2)
|
Baseline
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| AMIEL-TISON ANGLE |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
01/04/2025 |
| 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="3"
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
|
The babies born before the completion of 37 weeks of gestation is termed as preterm infants by WHO. They are further classified into extremely preterm infants (<28 weeks), very preterm (28- <32 weeks) and moderate to late preterm (32- <37 weeks) based on their gestational age (1). In every 1000 babies 2-5 babies are born prematurely (2) . Intrauterine and extrauterine growth varies in preterm infants compared to full term infants as they are born prematurely. Muscle tone of preterm infants is reduced due to the maturity related hypotonia. Reduced muscle tone can have an impact in the later development (3). Preterm infants are at greater risk for mortality and variety of developmental and health problems. Complications include acute respiratory, gastrointestinal, immunologic, central nervous system, hearing, and vision problems, as well as longer-term motor, cognitive, visual, hearing, behavioural, social-emotional, health, and growth problems(4). Motor development varies in preterm infants compared to full term infants (5). Changes in motor development in preterm babies compared to full-term babies can include delays and differences in the achievement of motor milestones, variations in muscle tone, and potential difficulties with coordination and fine motor skill (6). The preterm infants demonstrate different motor behaviours from their term peers, with an uneven progression of motor skills in different positions from 4 to 8 months of corrected age. At 8 months 90% of the term infants are able to sit without arm support, but only 56% of the preterm infants could maintain sitting very briefly without arm support (5). It is important to recognise the changes taking place in the different type of preterm infants regarding muscle tone and their interactions with that of the motor development is important for evaluation and treatment planning(7). More precise and periodic assessments should be addressed at an early age to prevent problems in motor development. At 40 weeks the infants have maturation related hypotonia and the status of maturation related hypotonia is not well known as the child keeps on developing in various preterm infants. The development of muscle tone in the first year of life in various preterm infants is not well established. This study aims to identify the developmental status, muscle tone and its impact on the motor development in various preterm infants at 8th month of corrected age. |