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临床试验/NCT04906577
NCT04906577终止不适用

Effects of the Odour of the Very Preterm Infant on Maternal Psychobiology

Centre Hospitalier Universitaire de Nice1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2021年9月12日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
6
试验地点
1
主要终点
Change in ocytocine levels

研究概览

简要总结

At birth, the study of interactions, particularly sensory interactions between a mother and her child, allows us to better understand the process of attachment. The sensory signals within the mother-infant dyad will lead to behavioural and metabolic adaptations in both individuals. Currently, the conditions of reception of a very premature newborn in the neonatal intensive care unit of the CHU of Nice lead to a separation between mother and child, with a reduction in sensory interactions.

The immediate and long-term consequences of this "sensory rupture" are widely documented in the child, but little studied in the mother.

The hypothesis at the origin of this work is that olfactory stimulations emanating from the newborn would allow a perceptive continuity between the newborn and his mother. In the pathological situation of the birth of a premature child, these stimulations would lead to neurobiological and behavioural modifications in the mother and would play a role in the attachment process.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Immediate postpartum mothers of newborns with a term of < 33 weeks (32 weeks + 6 days)
  • primiparous mothers
  • Mothers with vaginal delivery, without oxytocin infusion after delivery
  • Mothers planning to breastfeed, with no maternal contraindication to breastfeeding

排除标准

  • Substance abuse: active smoking at the time of delivery, alcohol, drugs
  • Use of medication: antidepressants or psychotropic drugs or centrally acting anti-emetics
  • Active depression or history of depression (under medical care with medical follow-up) in the year preceding the birth, on questioning
  • Chromosomal abnormality or congenital malformation of pre- or post-natal diagnosis in the newborn
  • Language barrier not allowing proper explanation of the protocol and responses to questionnaires

结局指标

主要结局

Change in ocytocine levels

时间窗: Day 4

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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