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CTRI Number  CTRI/2023/04/051332 [Registered on: 06/04/2023] Trial Registered Prospectively
Last Modified On: 16/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   The Relationship Between How Strongly Children Can Hold Things and How Well They Can Breathe In, for Kids Who Were Born Early and are Now in School.  
Scientific Title of Study   Correlation Of Grip Strength And Inspiratory Pressure In Preterm School Going Children  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Shukra Chivate  
Designation  Assistant Professor  
Affiliation  KLE Academy of Higher Education and Research Institute of Physiotherapy 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
Belgaum
KARNATAKA
590010
India 
Phone  8494869446  
Fax    
Email  shukrachivate@klekipt.edu.in  
 
Details of Contact Person
Scientific Query
 
Name  Snehal Thaleshwar 
Designation  PG Student  
Affiliation  KAHER Institute Of Physiotherapy , Belgaum 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
Belgaum
KARNATAKA
590010
India 
Phone  9730488516  
Fax    
Email  snehalthaleshwar1998@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Snehal Thaleshwar 
Designation  PG Student  
Affiliation  KAHER Institute Of Physiotherapy , Belgaum 
Address  KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
KLE Academy of Higher Education and Research Institute of Physiotherapy Nehru Nagar Belgaum Karnataka India
Belgaum
KARNATAKA
590010
India 
Phone  9730488516  
Fax    
Email  snehalthaleshwar1998@gmail.com  
 
Source of Monetary or Material Support  
KLE Dr.Prabhakar KoreS Hospital and MRC 
 
Primary Sponsor  
Name  Snehal thaleshwar 
Address  189 plot no shivbasava nagar belagavi 590010 
Type of Sponsor  Other [[self-sponsored ]] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
snehal thaleshwar  KLE Dr. Prabhakar Kores Hospital and MRC  JNMC Campus , Nehru nagar Belgavi-590010
Belgaum
KARNATAKA 
9730488516

snehalthaleshwar1998@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research ad ethics Committee of KAHER Institute of Physiotherapy  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  preterm school going children  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  12.00 Year(s)
Gender  Both 
Details  Children born less than 37weeks of gestational age for preterm group, Children who were hospitalized after birth,Both genders between 8-12 years of age, Children whose parents allow them to participate in the study ,Preterm-born children going to normal private school 
 
ExclusionCriteria 
Details  Hearing and visual impairment. , Medically diagnosed Neurological conditions such as cerebral palsy, physical disabilities, or medical/physical deteriorating conditions., Musculoskeletal problems like fractures, any surgeries, pain, or trauma in the past 3 months , Any Congenital deformities, Diagnosed cardiorespiratory conditions 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-grip strength -Jamar Dynamometer
-maximum inspiratory pressure-u-tube Manometer  
-grip strength -baseline
maximum inspiratory pressure - baseline  
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   07/04/2023 
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="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   non yet  
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
Every year, approximately 1.5 million babies are born preterm (i.e., before 37 completed weeks of gestation), and this number is increasing day by day. The effect of preterm birth amongst some survivors may continue throughout life, impairing motor functioning and affecting long-term physical health which also includes lung functions and capacities in the later stages of life. Preterm birth can be subdivided based on gestational age: extremely preterm
(<28 weeks), very preterm (28 - <32 weeks), moderate preterm (32 - <34weeks), and late preterm birth (34 - <37 completed weeks). There is a greater majority that preterm are born 32-36 weeks. The incidence of preterm born in Belagavi is 8.6 %. Preschool children who are born preterm have various motor difficulties and challenges compared to term-born children and are poorer in the motor examinations. Grip weakness is linked to a number of poor health outcomes in later life , such as cardiovascular disease and functional disability. Regardless of whether the preterm birth need neonatal critical care, the survivors in children exhibit worsened respiratory symptoms. Grip strength is a helpful measurement that can be utilized as a general
indication of strength and health outcomes in adults. To reduce the possibly confounding effect of lower coordination, which is more likely to affect preterm infants, we used grip strength as a measure of strength rather than a more functional strength (e.g., standing long jump). Inspiratory pressure is a negative pressure the patient is able to generate when inhalation is done. It suggests muscle strength and ventilatory reserve. Maximum inspiratory pressure is one of the common ways the assess the strength of the inspiratory muscles. This pressure is also considered as equal to the strength of the peripheral muscles. The current study will be done to determine the correlation of grip strength and inspiratory pressure in preterm. It may also serve as a reference study
performed in the ICU.
 
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