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CTRI Number  CTRI/2020/11/028873 [Registered on: 03/11/2020] Trial Registered Prospectively
Last Modified On: 10/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Comparison in sensory processing patterns in 12-18 months preterm and term infants  
Scientific Title of Study   Comparison of patterns of sensory processing abilities among preterm infants and term infants aged 12-18 months. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Vaishnavi Vilas Pawar 
Designation  Post-graduate student 
Affiliation  Manipal College Of Health Professions, MAHE, Manipal 
Address  Department of Occupational Therapy, Third floor Manipal college of Health Professions, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9594841318  
Fax    
Email  vaishnavivpawar.01@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Banumathe KR 
Designation  Associate Professor, Department of Occupational Therapy 
Affiliation  Manipal College Of Health Professions, MAHE, Manipal 
Address  Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9035120310  
Fax    
Email  banumathe.kr@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Vaishnavi Vilas Pawar 
Designation  Post-graduate student 
Affiliation  Manipal College Of Health Professions, MAHE, Manipal 
Address  Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal.

Udupi
KARNATAKA
576104
India 
Phone  9594841318  
Fax    
Email  vaishnavivpawar.01@gmail.com  
 
Source of Monetary or Material Support  
Department of Pediatrics, Kasturba Hospital, Manipal. 
 
Primary Sponsor  
Name  Vaishnavi Vilas Pawar  
Address  Department of Occupational Therapy, Third floor Manipal college of Health Profession, MAHE, Manipal. 
Type of Sponsor  Other [Self] 
 
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 
Vaishnavi Vilas Pawar   Department of Pediatrics, KMC, Manipal.  Department of Pediatrics, Kasturba Hospital, Manipal, Udupi, KARNATAKA-576104
Udupi
KARNATAKA 		 9594841318

vaishnavivpawar.01@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of Preterm Infants and Caregivers of Term Infants  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil   Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  40.00 Year(s)
Gender  Both 
Details  Inclusion Criteria for Caregiver of Term and Preterm infants
-Caregiver of a preterm infants who born within a gestational period of less than 37 weeks and term infants who are born within gestational period of 37 to 41 weeks in Kasturba Hospital, within the duration of March 2019 to February 2020.
-who is able to read and understand English.
-taking care of the child for more than 6 months.
-Available information in medical records such as contact numbers of caregivers of infants
 
 
ExclusionCriteria 
Details  Exclusion criteria for caregiver of term infants and preterm infants
-Caregiver with cognitive and psychological dysfunction as per medical records. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Infant/Toddler Sensory Profile scores (7-36 months)  one time 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "68"
Final Enrollment numbers achieved (India)="68" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/11/2020 
Date of Study Completion (India) 03/03/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  

Title of the project: Comparison of patters of sensory processing abilities among pre-term infants and term infants aged 12-18 months.

Type of Study: Cross sectional study, single center study. 

Aim: To compare the patterns of sensory processing abilities between preterm infants and term infants at the age of 12-18 months.

Preterm infants are at risk of facing developmental challenges, including developing sensory processing disorder. Early screening and detection of sensory integration dysfunction are one of the necessities for better developmental outcomes in preterm infants. For this Infant/Toddler Sensory Profile (7-36 months) scale is using to measure a child’s sensory processing abilities and to profile the effect of sensory processing on performance in daily life of child. Questionnaire should be completed by caregiver who daily contacts the child for reporting frequency of behaviour i.e. almost, frequently, occasionally, seldom or almost never. So 40 Caregiver of a preterm infant who born within a gestational period of less than 37 weeks and 40 caregivers of Term infants who born within gestation period of 37 to 41 weeks in Kasturba Hospital, within the duration of March 2019 to February 2020 , who is able to read and understand English, taking care of the child for more than 6 months will be included in study. And caregivers with cognitive and psychosocial dysfunctions as per medical records will be excluded. Procedure of the study will be after registering in Clinical Trial Registry India: Selection of participants according to inclusion and exclusion criteria using purposive sampling method through information taken from medical records such as contact numbers of caregiver of infants born in the duration of March 2019 to February 2020, birth type of child (term or preterm birth), to check whether caregiver have any psychological and cognitive dysfunction and also to check infants has any complications. Then to explain the purpose of study to participants through telephone or face to face. To get informed consent from participants through online or in person. To send sensory profile questionnaire to participants through online (Google form) or face to face.  To do Data entry and data analysis. To write and submit thesis. Outcome will be Infant/ Toddler Profile Score (7-36 months). SPSS version-16 will be used for data analysis. Descriptive statistics such as mean (SD) for continuous variables and frequency (%) for categorical variables will be done. Frequency (%) will be done to analyse the prevalence of patterns of sensory processing abilities in preterm infants and term infants. Analysis of data will be done by using chi-square test for comparison between score of preterm infant group and term infant group.

 
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