Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- gene expression in candidate genes of the stress signalling pathway
研究概览
简要总结
The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin contact in moderate and late preterm infants. The main questions it aims to answer are:
- does skin-to-skin contact in moderate and late preterm infants influence gene expression in the stress signaling pathway?
- does skin-to-skin contact in moderate and late preterm infants improve the short- and long-term outcome?
Participants will either get immediate separation after vaginal birth or receive immediate skin-to-skin contact. Researchers will compare these two groups to answer the proposed questions.
详细描述
The planned study investigates prospectively the effect of early intervention (skin-to-skin contact in the delivery room) in moderate and late preterm infants on neonatal programming by determining gene expression in the stress signaling pathway. The working hypothesis of our project is that the intervention will affect gene expression in a way that subsequently leads to better long-term psycho-social and neurological development of these preterm infants. The study aims to improve the understanding of the correlation of behavioral and epigenetic parameters and prove the underlying hypothesis of a novel mechanistic link between immediate skin-to-skin contact in the delivery room and life-long stress tolerance.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the intervention blinding of participant and care provider is not possible. The investigators are part of the care providing team.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •preterm birth between gestational age of 32 0/7 and 36 6/7 weeks
- •vaginal delivery
- •singleton
- •informed consent before birth
排除标准
- •malformations or syndromes of the infant
- •resuscitation of the infant
- •maternal psychological or severe physical illness
- •lack of German language skills
研究组 & 干预措施
Standard care
After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes.
skin-to-skin contact
After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse.
干预措施: skin-to-skin contact (Procedure)
结局指标
主要结局
gene expression in candidate genes of the stress signalling pathway
时间窗: corrected 24 months of age
DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
gene expression in candidate genes of the stress signalling pathway
时间窗: 36 to 72 hours after birth
DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
gene expression in candidate genes of the stress signalling pathway
时间窗: corrected 6 months of age
DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.
次要结局
- social support(at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age)
- socio-economic status(at inpatient discharge (assessed from 3 to 60 days of life))
- General Movements(corrected 3 months of age)
- breastfeeding(at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age)
- impact of event scale(corrected 6 months of age)
- Parental Bonding(corrected 6 and 24 months of age)
- Parental Stress(corrected 6 and 24 months of age)
- mother-child-interaction(corrected 6 months of age)
- maternal depression(at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age)
- reactivity of hypothalamic-pituitary-adrenal-axis(36 to 72 hours after birth and corrected 24 months of age)
研究者
Katrin Mehler
Associate Professor
University of Cologne