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临床试验/NCT06365164
NCT06365164尚未招募不适用

Presence of the Rooting Reflex on Preterms' ? Study of the Emergence of Sensory Self-awareness in Premature Newborns: Comparison of the Rooting Reflex Response Between Facilitated Self-stimulation and External Stimulation

University Hospital, Grenoble1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2024年6月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
19
试验地点
1
主要终点
The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.

研究概览

简要总结

The main objective is to demonstrate the presence of the rooting reflex in premature and the emergence of sensory self-awareness in premature by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during quiet wakefulness.

The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness.

The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

详细描述

Touch is the first sense to develop in foetal life. Children born prematurely have early tactile skills, in particular the ability to discriminate and learn. These tactile skills can be expressed through the newborn's reflexes. The sensory exploration that takes place when reflexes are manifested can be the basis for tactile learning and, in particular, for the development of the baby's awareness of his own body, with discrimination of the self. As touch plays an essential role in the child's perceptual-cognitive development, studying the tactile skills of premature infants is an ideal approach for a better understanding of the development of primitive sensory awareness.

The main hypothesis is to confirm the tactile skills of the very premature newborn in exploring the rooting reflex and then to evaluate the emergence of sensory self-awareness, by comparing the response of the rooting reflex between facilitated self-stimulation and external stimulation.

The investigators assume a difference in response in favour of a greater response of the newborn to external tactile stimulation compared to facilitated self-stimulation in favour of the distinction between self and non-self showing the emergence of a sensory awareness of self in the preterm newborn.

The study of the specific sensory of the premature newborn is part of the continuum of developmental care, and is part of an approach to improving the care delivered in neonatology with the aim of encouraging the best neurological development.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
28 Weeks 至 37 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Children born prematurely between 28 and 37 weeks of amenorrhoea, aged at least 3 days.

排除标准

  • Premature newborns with :
  • respiratory assistance (invasive or non-invasive ventilation)
  • malformative syndrome
  • a genetic syndrome
  • neurological damage such as stage III or IV intraventricular haemorrhage or periventricular leukomalacia,
  • sedative treatment: morphine, clonidine
  • aminergic treatment
  • acute pathology: shock, sepsis, acute cardiac failure, acute respiratory failure, etc.

结局指标

主要结局

The emergence of sensory self-awareness in premature newborns by showing a difference in the response of the rooting reflex to external tactile stimulation and to facilitated tactile self-stimulation during calm awakening.

时间窗: The data will be collected for one year. Each newborn baby can be included for 14 weeks.The intervention is 5 to 10 minutes corresponding to external stimulation and facilitated self-stimulation spaced at least 2 hours apart and for up to 48 hours.

First the external stimulation procedure is 30-second phase of observation. Next, the experimenter touches the corner of the infant's mouth and repeatedly with his index finger (about 5 gentle touches of about 10 seconds, repeated about 5 times) depending on the state and commitment of the newborn, ending with a final observation period of 30 seconds. The facilitated self-stimulation procedure will begin and end with a 30-second observation period. Then the experimenter will place the newborn's elbow close to his body, allowing him to touch his face alone with his hand, on one side then the other, for 30 seconds, with 2 to 5 trials depending on the child's level of commitment. The coding use a qualitative scale of four behaviours from 1 to 4 that are increasingly representative of the rooting reflex. The primary outcome is defined by an average score of the relative frequencies representative of the rooting reflex and will be compared between the two stimulation conditions.

次要结局

  • The secondary objective is to show a longitudinal progression in the emergence of the rooting reflex by repeated inclusions (seven days minimum) at different terms for the same newborn.(Each subject will be able to take part in up to three interventions, each at least 7 days apart, until they reach 41 weeks' gestation. The data will be collected for one year. Each newborn baby can be included for 14 weeks.)

研究者

发起方
University Hospital, Grenoble
申办方类型
Other
责任方
Sponsor

研究点 (1)

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