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临床试验/CTRI/2024/09/073967
CTRI/2024/09/073967尚未招募不适用

Association of feeding issues with speech production in premature toddlers.

Najla Kunnool1 个研究点 分布在 1 个国家目标入组 51 人开始时间: 2024年9月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
51
试验地点
1
主要终点
prominent measures used to study the usefulness associations between the prominent variables and

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
1.00 Year(s) 至 3.00 Year(s)(—)
性别
All

入选标准

  • History of preterm birth less than 37 weeks of gestation Toddlers in the age range of 1-3 years.

排除标准

  • Delayed birth cry Any medical conditions such as seizures.

结局指标

主要结局

prominent measures used to study the usefulness associations between the prominent variables and

时间窗: 10 months

groups or themes generated at the end of the study

时间窗: 10 months

Feeding concern which includes physiological symptoms problematic

时间窗: 10 months

mealtime behaviours selective/ restrictive feeding and oral processing and speech production are the

时间窗: 10 months

次要结局

未报告次要终点

研究者

发起方
Najla Kunnool
申办方类型
Other [Self ]
责任方
Principal Investigator
主要研究者

Najla Kunnool

Manipal College of Health Professions Manipal Academy of Higher Education

研究点 (1)

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