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临床试验/NCT04827225
NCT04827225进行中(未招募)不适用

Assessment of the Mental State of Parents of Premature Children and Impact on Neurodevelopment of the Child (Parents Psychic Preterm)

University Hospital, Angers2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020年10月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
300
试验地点
2
主要终点
Assessing the psychic profile of parents of children born prematurely

研究概览

简要总结

The objective of the study is to assess the psychic profile of parents of children born prematurely

详细描述

Prematurity affects aroound 1 in 10 children worlwide. Many studies have shown the role of prematurity in the development of depression, anxiety, post-traumatic stress disorder, mother-to-child attachment disorders, but few studies have sought to assess the evolution of this profile over time as well as to assess all of the parents' psychic dimensions.

The investigators currently have little knowledge of risk factors (psychological or psychiatric history, follow-up undertaken, treatments implemented, etc.) that may favor the occurrence of postpartum mental disorders (anxiety, depression, post-traumatic stress disorder ).

The investigators will thus seek to identify them. Prematurity can have a negative impact on the parents' psychic experience in the postpartum period. However, few studies have examined the evolution over time of the parental psychic profile and its possible repercussions on the child in terms of attachment and becoming neurodevelopmental. Finally, the majority of studies dealing with these subjects concern only mothers.Tthe investigators will endeavor here to also take into account the fathers.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • Parents whose child meets the following criteria:
  • Singleton child
  • Child aged up to 40 weeks of amenorrhea of age corrected at the time of inclusion
  • Premature child as defined below:
  • Born at a term less than or equal to 34 weeks of amenorrhea And or
  • weighing 1500g or less at birth
  • Hospitalized in the neonatology department of the Angers University Hospital
  • Child included in Réseau Grandir Ensemble (RGE) in Pays de la Loire
  • Informed consent form signed by both parents for their participation and the collection of data from the RGE for the child
  • Non-inclusion Criteria:
  • Parents not fluent in the French language, implying not being able to complete the various questionnaires
  • Parents including the child :
  • Is from a twin pregnancy or more
  • Has polymalformative syndrome or chromosomal abnormalities

排除标准

  • - Death of the child or one of the parents during follow-up

研究组 & 干预措施

PoPPY Group

Mother, Father and child born prematurely

干预措施: questionnaires (Behavioral)

结局指标

主要结局

Assessing the psychic profile of parents of children born prematurely

时间窗: At 38 weeks of amenorrhea (+/- 2 weeks)

The psychic profile of the parents will be evaluated from the score obtained in the following autoquestionnaire : \- parental depression (Edinburgh Postnatal Depression Scale (EPDS)), a score greater than or equal to 10 is in favour of parental depression

次要结局

  • Assess the parental stress(At 24 months corrected age)
  • Investigate the presence of peritraumatic dissociation experiments(At 38 weeks of amenorrhea (+/- 2 weeks))
  • Study the impact of the parental psychic profile on the neurological development of the child(At 24 months corrected age)
  • Assess the mother's attachment to her child(At 38 weeks of amenorrhea and 3 months corrected age of the child)
  • study perinatal or prenatal psychological and psychiatric factors associated with depression, anxiety and post traumatic stress(at 38 weeks of amenorrhea (+/- 2 weeks), and 3 months corrected age and at 24 months corrected age)
  • Study the evolution of parents' psychic profile over time(At 3 months corrected age and at 24 months corrected age)

研究者

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

研究点 (2)

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