Analysis of Mother-child Interaction as Well as Expression and Methylation of Candidate Genes of Stress Signaling Pathways in Mature Infants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Analysis of the mother-child interaction of mature infants at the age of six months
研究概览
简要总结
The planned study will investigate the quality of mother-child interaction at the age of 6 months as well as the expression and methylation of candidate genes of stress signaling pathway in mature infants.
At best, mother and the healthy, term newborn are undisturbed after birth. This creates optimal conditions for the development of a good mother-child interaction. The results of the mother-child interaction and the molecular genetic investigations will be compared to the results of the randomized controlled delivery room skin-to-skin study (deisy, clinicaltrial.gov identifier: NCT 01959737). This study showed a significant difference in the mother-child interaction and expression of candidate genes in preterm infants with or without skin-to-skin contact after birth.
The investigators hypothesize that the quality of mother-child interaction at the age of six months will be better in term newborns without postpartal separation of mother and child than in preterm infants with or without skin contact after birth. The second hypothesis is that there will be a difference in the expression and methylation of candidate genes of stress signaling pathway in these infants.
详细描述
A separation of mother and child after birth can influence the quality of mother-child interaction and the regulation of stress signaling pathways. Maternal depression, parental stress and socioeconomic status can also affect the quality of mother-child interaction.
A former controlled randomized delivery room skin-to-skin study (deisy) showed, that skin contact of preterm infants and their mothers after birth improves the mother-child interaction. It also leads to a differential expression of candidate genes of the stress signaling pathways, which suggests a long term effect on mechanisms in stress response. The study group should now be compared to a group of mature infants with a normal, uninterrupted postnatal course.
The hypothesis is that the intervention in the deisy study (early skin-to-skin contact of preterm infants and their mothers) improves the mother-child interaction so that it is nearly comparable to mature infants with uninterrupted mother-child contact after birth. Furthermore it is assumed that the expression and methylation of candidate genes of the stress signaling pathways will be influenced by the intervention in the same way.
The mother-child interaction will be evaluated at the age of six months with a standardized method (Mannheim Rating Scales). Questionnaires about maternal depression, social support, socio-economic status, parental stress and mother-child relationship disorders as well as samples for the molecular genetic testing will be collected on the third day of life and at the age of six months. For the molecular genetic testing one blood sample and buccal swabs will be taken. The blood sample will not be done additionally but with a routine blood sampling on the third day of life (screening of inborn errors of metabolism).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Day 至 3 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •mature newborn (38 to 41 weeks of gestational age)
- •first child
- •no separation of mother and child for three hours after birth
- •informed consent
排除标准
- •multiples
- •malformations or syndromes in the infant
- •maternal psychological or severe physical illness
结局指标
主要结局
Analysis of the mother-child interaction of mature infants at the age of six months
时间窗: at the age of six months
Mother-child interaction is investigated at the age of six months using Mannheim Rating Scales. Therefore a four-minute-videotape of the mother changing the infant's diapers and playing with the infant is used. Mannheim Rating Scales is a good validated standardized observation instrument. Stimulation and response from the mother as well from the infant are being recorded. Different communication channels can be used by mother and child (vocal, facial or motor). All behaviors are analysed at intervals of five seconds (event coding). Then the values are formed from the sum of the coded events. The scale ranges from 0 to 48. If there is no interaction, the scale is 0. If there is an interaction in each interval (every 5 seconds in a 4 minute videotape), the scale is 48. The mother-child interaction is better if the scale is higher.
次要结局
- Analysis of expression and methylation of candidate genes of stress signaling pathways from infant blood (on the third day of life) as well as mucosal epithelial cells (buccal swab on the third day of life and at the age of six months)(third day of life and age of six months)
- parental stress(third day of life and age of six months)
- Social support(third day of life and age of six months)
- Parental Bonding(third day of life and age of six months)
- Maternal depression(third day of life and age of six months)
- socio-economic status(third day of life and age of six months)
研究者
Katrin Mehler
adjunct professor, medical doctor Katrin Mehler
University of Cologne