Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: measurement of cortisol level.
- Who it may be relevant to
- Registry conditions: Stress, Psychological, Father-Child Relations, Premature Birth. Basic parameters: 1 Day — 7 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
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).
Interventions
- Diagnostic test measurement of cortisol level
We will measure the cortisol level from the hair sample of the father at three time points. Furthermore the father will answer questionnaires at three time points and the paternal sensitivity is measured once.
Primary outcome measures
- hair cortisol level [Time frame: first week after birth, 3 and 6 months after birth]
Secondary outcome measures (10)
- Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair [Time frame: first week after birth, 3 and 6 months after birth]
- paternal sensitivity [Time frame: 6 months after birth]
- father-child-interaction [Time frame: six months of age]
- paternal depression [Time frame: first week, 3 and 6 months after birth]
- socioeconomic status [Time frame: first week after birth]
- social support [Time frame: three months after birth]
- impact of event scale [Time frame: six months after birth]
- Parental Bonding [Time frame: first week, 3 and 6 months after birth]
- Parental Stress [Time frame: six months after birth]
- Parental Stress [Time frame: first week, 3 and 6 months after birth]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- University Hospital of Cologne — Cologne
Identifiers
NCT: NCT05969431 · 23-114058