NCT05969431 Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
| NCT ID | NCT05969431 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Cologne |
| Condition | Stress, Psychological |
| Study Type | OBSERVATIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 120 participants in total. It began in 2024-10-01 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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
Contact & Investigator
Katrin Mehler, PD Dr.
PRINCIPAL INVESTIGATOR
University of Cologne
Frequently Asked Questions
Who can join the NCT05969431 clinical trial?
This trial is open to participants of all sexes, aged 1 Day or older, up to 7 Days, studying Stress, Psychological. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05969431 currently recruiting?
Yes, NCT05969431 is actively recruiting participants. Contact the research team at eva.heine@uk-koeln.de for enrollment information.
Where is the NCT05969431 trial being conducted?
This trial is being conducted at Cologne, Germany.
Who is sponsoring the NCT05969431 clinical trial?
NCT05969431 is sponsored by University of Cologne. The principal investigator is Katrin Mehler, PD Dr. at University of Cologne. The trial plans to enroll 120 participants.