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临床试验/CTRI/2020/11/028873
CTRI/2020/11/028873已完成不适用

Comparison of patterns of sensory processing abilities among preterm infants and term infants aged 12-18 months.

Vaishnavi Vilas Pawar1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年7月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
Infant/Toddler Sensory Profile scores (7-36 months)

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • •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
  • •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.

排除标准

  • •Exclusion criteria for caregiver of term infants and preterm infants -Caregiver with cognitive and psychological dysfunction as per medical records.

结局指标

主要结局

Infant/Toddler Sensory Profile scores (7-36 months)

时间窗: one time

次要结局

未报告次要终点

研究者

发起方
Vaishnavi Vilas Pawar
申办方类型
Other [self]

研究点 (1)

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