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临床试验/NCT05992181
NCT05992181已完成不适用

Development of a Digital Tool for the Individualization of Speech Therapy Care for Premature Newborns

Centre Hospitalier Sud Francilien2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2023年9月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
2
主要终点
Milk taken daily

研究概览

简要总结

The study concerns the creation and implementation of a digital tool presenting the various orofacial stimuli that can be offered to premature newborns. This app is intended for parents, to allow them to play a more active role in their child's care, and provide them with special time with their child. The notion of pleasure is very important to us, and it's vital to help parents rediscover this feeling with their child. Different profiles will be created to individualize our recommendations, facilitate the understanding of orofacial stimuli, make them more concrete than drawings, and provide care adapted to each patient and improve the development of newborns through more regular orofacial stimulation.

详细描述

Two groups will be formed:

Group A - control: receiving the speech therapy currently in place in the department.

Group B - experimental: will receive the same care as the first group, plus access to the videos and the introduction of early orofacial stimulation.

Group B: First, an initial assessment will be performed in speech-language pathology of the oro-myofunctional and oral functions of the newborn. This will determine which orofacial solicitations to give to the baby and create in the patient's profile.

Parents will be trained in orofacial stimulation and will be coached during the first sessions. When parents are ready, access will be given to their personal space on the application. Appointments will be scheduled to remodel the treatment if necessary. Sucking (ECEPAB), feeding (PIBBS) and behavioural (EDIN) abilities will be assessed. Parents will be asked to fill out a questionnaire about their feelings.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
24 Hours 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Child born prematurely before 29 weeks of amenorrhea (SA).
  • Alive for minimum 24h.
  • Holders of parental authority who have been informed of the study and have not objected.

排除标准

  • Child born after 29 weeks of amenorrhea.
  • with a genetic or severe neurological pathology or withdrawal syndrome.
  • with a vital prognosis.
  • whose family home is too far from the service.

结局指标

主要结局

Milk taken daily

时间窗: up to 3 months

Percentage of the amount of milk taken daily (measure taken once per week throughout the study).

次要结局

  • satisfaction questionnaire(Day 90)
  • Milk flower (PIBBS questionnaire)(Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90)
  • anxiety questionnaire(Day 0, Day 30, Day 60, Day 90)
  • Behavior scale for the analysis of oral reflexes and suction reflexes (MIAM questionnaire)(Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90)
  • Feeding behavior scale for premature infants moving to bottle-feeding (ECEPAB questionnaire(Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90)
  • Newborn Pain and Discomfort Scale (EDIN questionnaire)(Day 0, Day 15, Day 30, Day 45, Day 60, Day 75, Day 90)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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