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临床试验/NCT04118751
NCT04118751Unknown不适用

Impact of Premature Childbirth on Parental Outcomes During Baby's NICU Stay and Beyond: "Preterm Parents" Study on Polish Cohort

University of Gdansk1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年11月5日最近更新:
适应症

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
Bonding between primary caregiver and infant

研究概览

简要总结

The main objective of this project is examining whether there is a relationship between preterm delivery and parental' problematic emotional bond in the early postpartum period.

The secondary outcomes are as follows:

  • To evaluate whether there are any differences and similarities between fathers' and mothers' level of parental bonding, stress, anxiety, and depression symptoms in case of premature birth.
  • To evaluate whether there is a relationship between preterm delivery and the persistence of maternal' problematic emotional bond three months after childbirth.
  • To indicate what kind of predictors might affect the parental' problematic bond in the early postpartum period.

研究设计

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

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Parents of children born below the 37th week of pregnancy (clinical group) or above the 37th week of pregnancy (control group) hospitalised in a neonatal setting during recruitment period
  • Which agreed participating to the study after having complete information about it and sign a consent.

排除标准

  • Parents may not participate in the study if one of them suffers from a serious mental illness.

结局指标

主要结局

Bonding between primary caregiver and infant

时间窗: From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery

Mean score of both parents of preterm babies hospitalized in NICU and parent of full-term babies on Postpartum Bonding Questionnaire (PBQ). Total score of the PBQ, a parent-rated screening instrument for disorders of the early parent-infant relationship consisting of 25 statements on a six-point Likert scale (each 0-5; sum score ranging from 0 to 125; high = problematic).

次要结局

  • Parental anxiety(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)
  • Parental stress(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)
  • Bonding between mother and infant(Through study completion, an average of 3 months)
  • Parental depression(From date of admitted to a NICU until discharge from hospital, assessed up to 7 days after delivery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Łucja Bieleninik

Assistant Professor

University of Gdansk

研究点 (1)

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