Measuring stress in fathers of preterm and term infants using hair cortisol
Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
This study looks at stress levels in fathers of preterm babies compared to those with full-term babies by testing their hair for cortisol and checking in with them over six months.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 1 Day to 7 Days |
| Sex | All |
| Sponsor | University of Cologne Academic / other |
| Locations | 1 site (Cologne, Northrhine-westfalia) |
| Trial ID | NCT05969431 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare cortisol levels in the hair of fathers with preterm infants to those with term infants, as a marker of chronic stress. Participants will provide hair samples and complete questionnaires at three different time points: one week, three months, and six months after the birth of their child. The study will also assess paternal sensitivity at six months of the infant's age. The goal is to understand how stress levels differ between these two groups of fathers and how they change over time.
Who should consider this trial
Good fit: Ideal candidates for this study are fathers of infants born either prematurely or at term, who can provide informed consent and have sufficient knowledge of German.
Not a fit: Patients who may not benefit from this study include adoptive or foster fathers, those with endocrine disorders, or those taking medications that affect cortisol levels.
Why it matters
Potential benefit: If successful, this study could provide insights into the psychological stress experienced by fathers of preterm infants, potentially leading to better support and interventions.
How similar studies have performed: While the approach of measuring cortisol in hair is established, this specific comparison between fathers of preterm and term infants is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Cologne, Northrhine-westfalia
- University Hospital of Cologne — Cologne, Northrhine-westfalia, Germany (Recruiting)
Study contacts
- Principal investigator: Katrin Mehler, PD Dr. — University of Cologne
- Study coordinator: Eva Heine, Dr. med.
- Email: eva.heine@uk-koeln.de
- Phone: 004922147885663
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.