FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/09/073967 [Registered on: 17/09/2024] Trial Registered Prospectively
Last Modified On: 05/09/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Relationship between feeding problems and speech production in toddlers with preterm birth 
Scientific Title of Study   Association of feeding issues with speech production in premature toddlers.  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Najla Kunnool 
Designation  Post Graduate Student Pursuing MSc in Speech Language Pathology 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal

Udupi
KARNATAKA
576104
India 
Phone  9108082089  
Fax    
Email  najla.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education Manipal 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Veena K D 
Designation  Associate Professor 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher Education Manipal 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448824346  
Fax    
Email  r.veena@manipal.edu  
 
Source of Monetary or Material Support  
Manipal College of Health Professions Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi Karnataka India 576104 
 
Primary Sponsor  
Name  Najla Kunnool 
Address  Department of Speech and Hearing Manipal College of Health Professions 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 
Dr Veena K D  Kasturba Hospital  Paediatric OPD Department of Paediatrics Ground floor Women and children block Kasturba Medical College Manipal
Udupi
KARNATAKA 		 9448824346

r.veena@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
KMC and KH Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O601||Preterm labor with preterm delivery,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  1.00 Year(s)
Age To  3.00 Year(s)
Gender  Both 
Details  History of preterm birth less than 37 weeks of gestation
Toddlers in the age range of 1-3 years 
 
ExclusionCriteria 
Details  Delayed birth cry
Any medical conditions such as seizures 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Feeding concern which includes physiological symptoms problematic
mealtime behaviours selective/ restrictive feeding and oral processing and speech production are the
prominent measures used to study the usefulness associations between the prominent variables and
groups or themes generated at the end of the study 		 10 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   21/09/2024 
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="10"
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   Title of the project: Association of feeding issues with speech production in premature toddlers.

Type of Study: Observational prospective study- cross sectional study.

Aim & objective : Aim is to investigate the association of feeding issues with speech production in premature toddlers.
Objective is to adapt and validate Pediatric Eating Assessment Tool (Pedi-EAT) (Thoyre et al., 2014) and to evaluate the association between feeding issues and speech production in premature toddlers.

Justification for study: Feeding and speech production are interconnected in their shared developmental aspects of oral motor skills and muscle coordination. The same articulators needed for a coordinated movement to produce distinct speech sounds are also crucial for adequate feeding. Few studies have explored the link between language delays and feeding difficulties. However, understanding the correlation between speech production and feeding issues in premature children resides in the limited exploration of specific feeding practices and their impact on speech and language development.

Departments involved: Department of Speech and Hearing, Manipal College of Health Professions and Department of Paediatrics, Kasturba Medical College, Manipal. 

Sample size: 51

Materials and methods:  a) Inclusion criteria: History of preterm birth (< 37 weeks of gestation) Toddlers (1-3 years)
                                       b) Exclusion criteria: Delayed birth cry Any medical conditions such as seizure

Statistical methods: - The assessment tool will be subjected to internal consistency reliability, test-retest reliability, and content validity. 
                                   - Descriptive statistics will be used to report the study outcomes using Jamovi version 2.4.11 
                                   - Correlation analysis and regression (logistic or linear) analysis will be used to determine the association between feeding issues and speech development. 

Procedure: 
  • Obtain permissions and approvals
  • Research committee approval
  • Adaptation and validation of Pediatric Eating Assessment Tool (Pedi-EAT) (Thoyre et al., 2014
  • Obtain permission from KMC, Manipal
  • Ethical approval
  • Recruitment participants meeting inclusion criteria
  • Informed written consent
  • Collect general proforma details
  • Assess feeding issues
  • Assess speech and language
  • Data analysis
Outcome measures: Feeding concern which includes physiological symptoms, problematic mealtime behaviours, selective/ restrictive feeding, and oral processing and speech production are the prominent measures used to study the usefulness, associations between the prominent variables and groups or themes generated at the end of the study

Potential risks and benefits: A minor increase over minimal risk is anticipated in terms of discomfort, anxiety, and time needed to complete the tasks as it may require them to complete a total of 78 questions of the parent rated questionnaire in addition to the questionnaire administered by the principal investigator. This will be mitigated by giving the participant sufficient time required. Indirect benefit to the participant is present as they will gain awareness of the importance of early intervention of children with a history of preterm birth. 

Ethical considerations: The study will begin after obtaining required IEC, IRC and CTRI approvals. Written informed consent will be obtained from all the participants. The data obtained for the study will be used strictly for academic and research purpose by Principal Investigator/Guide and high confidentiality will be maintained with proper ethical considerations. 

Budget and proposed funding source: Not applicable.

Review of literature: 
  • Feeding issues are prevalent in preterm infants.
  • Language delay was more common in premature infants who had feeding issues.
  • The number of days spent in NICU also correlated with feeding issues and delay in language development. 
  • Overall neurodevelopmental delay has been reported in premature infants with feeding issues. 
 
Close