Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- hair cortisol level
研究概览
简要总结
The goal of this observational study is to compare the paternal hair cortisol as a marker for chronic stress in prematurely born children to maturely born children.
The main questions it aims to answer are:
- How differ the cortisol level between groups?
- How change the cortisol level over time?
- Are there secondary outcomes associated to the cortisol level of fathers? Participants will give a hair sample to analyse the cortisol level and fill out questionnaires at three time points. At six months of the infant's age, the investigators will also measure the paternal sensitivity.
详细描述
For expectant parents, the birth of a child is often a stressful situation. In the case of a premature birth, the psychological stress is usually increased because the parents frequently could not prepare for the birth. Therefore, the researcher would like to investigate this stress of fathers of newborn children.
For this purpose, the stress hormone cortisol in the fathers' hair will be analysed and questionnaires on the fathers' mental health will be collected. Subsequently, the differences between fathers of prematurely born and of maturely born children will be compared.
The investigators will do the analyses at three time points: the first time point will be at the first week after birth, the second three months and the third six months after birth. At six months of the infant's age, additionally the paternal sensitivity will be measured.
The compared groups will differ with respect to gestational age: Group 1 includes preterm infants with a gestational age below 32 weeks and a birth weight <1500 grams (very low birthweight infants), group 2 preterm infants with a gestational age between 32 0/7 to 36 6/7 (moderate and late preterm infants) and group 3 consists of mature infants (over 37 weeks gestational age).
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 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Premature or mature infant (22 0/7 to 42 0/7 weeks of gestation)
- •For mature infants (37 0/7 to 42 0/7 weeks of gestation) undisturbed neonatal period
- •No severe malformations or genetic diseases of the newborn child
- •Sufficient knowledge of German of the father
- •written consent of the custodial parents
排除标准
- •adoptive or foster paternity
- •hair length below 3 cm at the posterior vertex region of the back of the father's head
- •endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome, adrenal insufficiency)
- •taking steroidal medications or other drugs that affect the activity of the hypothalamic-pituitary-adrenocortical system
- •paternal psychological or severe physical illness
结局指标
主要结局
hair cortisol level
时间窗: first week after birth, 3 and 6 months after birth
The level of cortisol will be measured in the hair of the fathers by liquid chromatography with tandem mass spectrometry. This test is validated in human hair and the current gold standard method in hair steroid analysis. The analytic procedure follows a published laboratory protocol that has excellent sensitivity, specificity and reliability.
次要结局
- Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair(first week after birth, 3 and 6 months after birth)
- paternal sensitivity(6 months after birth)
- father-child-interaction(six months of age)
- paternal depression(first week, 3 and 6 months after birth)
- socioeconomic status(first week after birth)
- social support(three months after birth)
- impact of event scale(six months after birth)
- Parental Bonding(first week, 3 and 6 months after birth)
- Parental Stress(first week, 3 and 6 months after birth)
研究者
Katrin Mehler
Associate Professor
University of Cologne