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临床试验/NCT01959737
NCT01959737已完成不适用

Influence of Early SSC of Mothers and Their VLBW Infants on Maternal Sensitivity and Responsiveness, Attachment Patterns and Reactivity of HPA Axis. Molecular Characterization of SSC Influence on Stress Signaling Pathways.

University of Cologne1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2013年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
88
试验地点
1
主要终点
Maternal sensitivity and responsiveness

研究概览

简要总结

The first hours after birth are a sensitive period for promotion of optimal mother-child-interaction and secure attachment. Maternal sensitivity and responsivness are high in the first hours after birth due to high oxytocin levels. Developing optimal mother-child-interaction is more difficult for preterm mothers because mother and child are separated after birth and the preterm infant is not able to show strong signs to promote maternal sensitivity. We hypothesize that promoting skin-to-skin contact of VLBW infants and their mothers for 60 minutes within the first hours after birth improves mother-child-interaction at 5 to 6 months corrected age. We also hypothesize that reactivity of HPA axis and molecular patterns of stress signaling pathways differ in preterm infant with or without SSC after birth.

研究设计

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

入排标准

年龄范围
10 Minutes 至 60 Minutes(Child)
性别
All
接受健康志愿者

入选标准

  • Birthweight <1500g, first child, informed consent

排除标准

  • Multiples, malformation

研究组 & 干预措施

visual contact

No Intervention

After initial assessment/stabilization of the VLBW infant, visual contact of mother and infant is permitted for 5 minutes.

skin-to-skin contact

Experimental

After initial stabilization mother and preterm infant are cared for skin-to-skin for 60 minuter. SSC is supervised by the attending neonatologist.

干预措施: skin-to.skin-contact (Procedure)

结局指标

主要结局

Maternal sensitivity and responsiveness

时间窗: 4 to 6 moinths corrected age

Maternal sensitivity and responsiveness are assessed with the "Mannheimer Method" for the analysis of mother child interaction. At the infants corrected age of 4 to 6 months a videotape of the mother changing the infants diapers and playing with the infant is used for analysis.

次要结局

  • Reactivity of HPA-axis(36 to 40 weeks corrected age)
  • Molecular characterization of stress signaling pathways(36 to 40 weeks corrected age)

研究者

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

Katrin Mehler

MD

University of Cologne

研究点 (1)

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