RecruitingNot Applicable

Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study

Germany120 participantsStarted 2024-10-01

Plain-language 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.

Who can participate

Age range

1 Day – 7 Days

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

hair cortisol level

Timeframe: first week after birth, 3 and 6 months after birth

Trial details

NCT IDNCT05969431

SponsorUniversity of Cologne

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-06-30

Contact for this trial

Eva Heine, Dr. med.

004922147885663 eva.heine@uk-koeln.de

View on ClinicalTrials.gov More Stress, Psychological trials