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

NCT05969431 | Recruiting

• 1 other identifier: 23-114058
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress, Psychological; Father-Child Relations; Premature Birth

Outcome Measures

Primary Outcomes (1)

• hair cortisol level

  The level of cortisol will be measured in the hair of the fathers by liquid chromatography with tandem mass spectrometry. This test is validated in human hair and the current gold standard method in hair steroid analysis. The analytic procedure follows a published laboratory protocol that has excellent sensitivity, specificity and reliability.

  first week after birth, 3 and 6 months after birth

Secondary Outcomes (10)

• Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair

  first week after birth, 3 and 6 months after birth

• paternal sensitivity

  6 months after birth

• father-child-interaction

  six months of age

• paternal depression

  first week, 3 and 6 months after birth

• socioeconomic status

  first week after birth

Study Arms (3)

fathers of mature infants

Fathers of newborns' above 37 weeks of gestation

Diagnostic Test: measurement of cortisol level

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.

Diagnostic Test: measurement of cortisol level

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.

Diagnostic Test: measurement of cortisol level

Interventions

measurement of cortisol level DIAGNOSTIC_TEST

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.

Also known as: questionnaire

fathers of mature infants; fathers of moderate and late preterm infants; fathers of very low birth weight preterm infants

Eligibility Criteria

• Age: 1 Day - 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Fathers of newborns born at the university hospital of Cologne

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Cologne: lead
• University of Siegen: collaborator

Study Sites (1)

University Hospital of Cologne

Cologne, Northrhine-westfalia, 50931, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

A hair sample will be taken from the back of the father's head (a thin strand of hair, approximately a total diameter of 3-5 mm). From this sample only the cortisol level will be measured.

MeSH Terms

Conditions

Stress, Psychological; Premature Birth

Interventions

Pain Measurement

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Neurologic Examination; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Katrin Mehler, PD Dr.

  University of Cologne

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Heine, Dr. med.

CONTACT

004922147885663; eva.heine@uk-koeln.de

Katrin Mehler, PD Dr.

CONTACT

004922147885663; katrin.mehler@uk-koeln.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 1, 2023
• Study Start: October 1, 2024
• Primary Completion: June 30, 2025
• Study Completion: December 31, 2025
• Last Updated: November 27, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)