Clinical trial NCT05969431: Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
Official title: Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stress, Psychological
Father-Child Relations
Premature Birth
Lead sponsor: University of Cologne
Sponsor class: OTHER
Collaborators: name: University of Siegen
First posted: 2023-08-01
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Fathers of newborns born at the university hospital of Cologne

Brief summary: 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).

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

Primary outcomes:
measure: hair cortisol level
timeFrame: first week after birth, 3 and 6 months after birth
Secondary outcomes:
measure: Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair
timeFrame: first week after birth, 3 and 6 months after birth
measure: paternal sensitivity
timeFrame: 6 months after birth
measure: father-child-interaction
timeFrame: six months of age
measure: paternal depression
timeFrame: first week, 3 and 6 months after birth
measure: socioeconomic status
timeFrame: first week after birth
measure: social support
timeFrame: three months after birth
measure: impact of event scale
timeFrame: six months after birth
measure: Parental Bonding
timeFrame: first week, 3 and 6 months after birth
measure: Parental Stress
timeFrame: six months after birth
measure: Parental Stress
timeFrame: first week, 3 and 6 months after birth
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital of Cologne
state: Northrhine-westfalia
Study officials:
affiliation: University of Cologne
name: Katrin Mehler, PD Dr.
role: PRINCIPAL_INVESTIGATOR
References: