| 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
|
|
|
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
|
|
|
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. |