Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
NCT ID: NCT05969431
Last Updated: 2024-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
120 participants
OBSERVATIONAL
2024-10-01
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
fathers of mature infants
Fathers of newborns' above 37 weeks of gestation
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.
fathers of moderate and late preterm infants
Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.
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.
fathers of very low birth weight preterm infants
Fathers of very low birth weight preterm infants, i.e. gestational age from 22 0/7 to 31 6/7 weeks of gestation and with a birth weight below 1500 g.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
1 Day
7 Days
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Siegen
UNKNOWN
University of Cologne
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Katrin Mehler
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Katrin Mehler, PD Dr.
Role: PRINCIPAL_INVESTIGATOR
University of Cologne
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University Hospital of Cologne
Cologne, Northrhine-westfalia, Germany
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
23-114058
Identifier Type: -
Identifier Source: org_study_id