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CTRI Number  CTRI/2024/10/075433 [Registered on: 17/10/2024] Trial Registered Prospectively
Last Modified On: 17/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Effect Of Early Treatment For Feeding And Talking On Babies Feeding And Speech Development  
Scientific Title of Study   Long-Term Effect Of Early Intervention Program Of Oral And Language Stimulation On Feeding And Communication Development In Infants 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Nuthan Kamath 
Designation  PhD Scholar 
Affiliation  Manipal College of Health Professions Manipal Academy of Higher education 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher education Madhav Nagar Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  8660845810  
Fax    
Email  nuthan.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 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher education Madhav Nagar Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9632949527  
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 
Address  Department of Speech and Hearing Manipal College of Health Professions Manipal Academy of Higher education Madhav Nagar Manipal Udupi

Udupi
KARNATAKA
576104
India 
Phone  9632949527  
Fax    
Email  r.veena@manipal.edu  
 
Source of Monetary or Material Support  
Dr TMA Pai Hospital, Udupi, Karnataka, India 576101 
 
Primary Sponsor  
Name  Nuthan N Kamath 
Address  Department of Speech & Hearing Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi Karnataka India 576104 
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  Dr TMA Pai Hospital Udupi  Department of Speech and Hearing First Floor Dr TMA Pai Hospital Court Road Udupi Karnataka India 576101
Udupi
KARNATAKA 
9632949527

r.veena@manipal.edu 
 
Details of Ethics Committee  
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 
Patients  (1) ICD-10 Condition: P928||Other feeding problems of newborn,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Early Intervention  The investigator will carry out the Early Intervention daily for Preterm Infants for seven days. This will be carried out twice a day, 30 minutes before the feeding, for a period of 20 minutes. This intervention includes stimulation for feeding and nonfeeding oral stimulation along with language stimulation. During the hospital stay, the mothers of the preterm infants in the intervention group will be trained by the investigator to carry out the intervention every day at home after hospital discharge, and the investigator will monitor to check if the mother is able to carry out the intervention program 
Comparator Agent  Standard care  Two groups, one consisting of preterm infants and the other of full-term infants, will receive standard care only. The development of feeding and communication will be monitored for the initial 9 months. 
 
Inclusion Criteria  
Age From  0.00 Month(s)
Age To  9.00 Month(s)
Gender  Both 
Details  Preterm infants born 34 to 37 weeks of Gestational age
Full-term infants born greater than 37 weeks of Gestational age
Birthweight more than 1.5 Kg
APGAR score greater than 7
 
 
ExclusionCriteria 
Details  Fullterm and preterm infants with severe respiratory conditions, kidney disease or congenital heart disease, seizures or any other syndromes 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Early feeding and swallowing skills
Problematic feeding
Parental feeding practices
Vocal development
Effectiveness of early intervention program
General health and overall growth
 
Baseline at 3rd day
Follow up at 45 days, 2.5 month, 3.5 month, 6 months, 8 moths, 9 months 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="42"
Sample Size from India="42" 
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   Phase 2 
Date of First Enrollment (India)   01/11/2024 
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="3"
Months="0"
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  

Children born preterm are at risk of several developmental concerns, such as cognitive delay, speech & language disorder, feeding disorder, and behavioral concerns. Oral feeding in preterm is considered essential for hospital discharge. However, the feeding problems can persist into childhood and later to adulthood despite achieving the readiness at the discharge. The language delay observed in preterm infants is a well-known phenomenon. Yet the exact reason behind it remains incompletely understood. Hence, further comprehensive research is needed to clarify the relationship between feeding and communication development and develop targeted intervention to support feeding and language development in preterm infants.  Early intervention program of oral and speech & language stimulation can help mitigate the effect of problematic feeding and speech & language delay in preterm infants. Hence, a continued assessment and early intervention of oral and speech & language stimulation is essential for promoting healthy speech and language development, overall feeding progression, lessen the long-term effects, and promoting overall healthy development in infants

Phase I

A structured Early Intervention program will be developed for feeding and communication development based on findings from parental interview and literature review. The program will include details on the oral stimulation (both intraoral and perioral) involving the oral musculature with nonnutritive sucking with the use of a gloved finger/pacifier and language stimulation which encourages parent/ caregiver to prompt vocalization from the infant. This program will be reviewed by 5 Speech Language Pathologists to rate each step to ensure the content of the developed program aligns with its intended purpose.

Phase II

After obtaining the informed consent form and providing a participant information sheet to the parents of recruited infants, birth history, medical history, and other necessary details will be documented. A group of full-term infants will be recruited along with two groups of preterm infants, 14 participants each ( 1. Preterm receiving standard care and 2. Preterm receiving intervention and standard care) to compare the feeding, speech, and language development between full-term infants and preterm infants. Using block randomization with a block size 4, twenty-eight preterm infants will be randomized to the preterms receiving Standard care only and Preterms receiving Intervention & standard care. The sequence generation will be performed using a computer-generated random number schedule with defined block sizes. Group allocation will be concealed using Sequentially Numbered Opaque Sealed Envelopes. After the allocation of the participants, the evaluation will be initiated on the third day of the infant’s age for feeding and speech and language skills. Informal assessment will be carried out by assessing the reflexes, behavioral state of the infant, demonstration of hunger, and coordination of sucking, swallowing, & breathing. Formal assessment will be carried out by the tool mentioned below.

1)      The Feeding Practice and Structure Questionnaire for parents with Infants and toddlers (Jansen et al., 2021)

2)      Infant Eating Assessment Tool (Pados et al., 2024)

3)      Preterm Infants Breastfeeding Behavior Scale (Nyqvist et al., 1999)

4)      Developmental vocal assessment form (Paul & Norbury, 2012)

5)      Receptive-Expressive Emergent Language Scale—3rd Edition (Bzoch, League, & Brown, 2003)

 

The developed EI will be carried out every day by the investigator for preterm infants for seven days. This will be carried out twice a day, 30 minutes before the feeding, for a period of 20 minutes. This intervention includes stimulation for feeding and nonfeeding oral stimulation along with language stimulation such as parent-child interaction, singing or speaking to the infant. Infants will be observed for signs of infections such as fever, irritability or changes in feeding. During the hospital stay, the mothers of the preterm infants in the intervention group will be trained by the investigator to carry out the intervention every day at home after hospital discharge, and the investigator will monitor to check if the mother is able to carry out the intervention program. The participants in the standard care group will receive the routine care such as Kangaroo mother care, nutritive and non nutritive sucking. The investigator will systematically monitor the mother’s adherence to EI practices via telephone calls. A log book will be provided to the mother, which will include the details of the intervention program, and a separate section will be included to document the intervention provided (frequency and duration). The preterm infants in the standard care group and the full-term group will receive routine care only. All three groups will be evaluated for feeding and communication development. All infants recruited to the study will be followed up when the infant visits the hospital for vaccination, i.e., at 45 days, two and half months, three and half months, sixth month, eighth month, and ninth month of age, and the evaluation will be repeated using the same tools. The responses of the evaluation will be documented for all three groups. After six months, the solid feeding version of FPSQ will be administered to all recruited infants along with other tools and findings will be documented. In addition to this, the mothers will be instructed to demonstrate the intervention carried out at home. Feedback regarding the intervention will be given to the mother. Mother will be retrained to carry out the intervention during each visit.

 
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