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Stress, PsychologicalNCT05969431

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

An observational study of Stress, Psychological and Father-Child Relations, run by University of Cologne at 1 site in Germany.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 1 day to 7 daysHealthy volunteers can take part
What is being tested?
measurement of cortisol level
How many people
120 participants
Where
1 siteGermany
Study dates
1 Oct 2024to 31 Dec 2025
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 1 day to 7 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Study population: Fathers of newborns born at the university hospital of Cologne

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Eva Heine, Dr. med. contact

004922147885663

eva.heine@uk-koeln.de

Katrin Mehler, PD Dr. contact

004922147885663

katrin.mehler@uk-koeln.de

Germany1 site, 1 recruiting
  • University Hospital of Cologne

    Cologne, Northrhine-westfalia, 50931

    Katrin Mehler, PhD, 004922147885663, katrin.mehler@uk-koeln.de

    Recruiting

Other trials in Germany

About this study

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.
Read the detailed description

For expectant parents, the birth of a child is often a stressful situation. In the case of a premature birth, the psychological stress is usually increased because the parents frequently could not prepare for the birth. Therefore, the researcher would like to investigate this stress of fathers of newborn children.

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).

Being tested
measurement of cortisol level
Medical subject headings
Stress, Psychological, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • measurement of cortisol levelDiagnostic test

    Also called questionnaire

    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.

Study groups in NCT05969431
Study groupRoleWhat they receive
fathers of mature infantsFathers of newborns' above 37 weeks of gestation
Receives: Diagnostic Test: measurement of cortisol level
fathers of moderate and late preterm infantsFathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.
Receives: Diagnostic Test: measurement of cortisol level
fathers of very low birth weight preterm infantsFathers 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.
Receives: Diagnostic Test: measurement of cortisol level

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

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

Secondary outcomes (10)
  1. Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair

    The level of these hormones (cortisone, testosterone, progesterone, dehydroepiandrosterone) 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 hormone analysis. The analytic procedure follows a published laboratory protocol that has excellent sensitivity, specificity and reliability.

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

  2. paternal sensitivity

    The paternal sensitivity and the father-child-interaction will be measured during a five-minute-videotape of the father changing the infants' diapers and playing with the infant. The paternal sensitivity will be measured by a 9-point scale. The score can range from 1 to 9, where 1 means lack of sensitivity and 9 means very sensitive. The classification is a validated tool and is done by two trained and reliable evaluators from the Department of Developmental Science and Special Education. The evaluators are blinded.

    Measured: 6 months after birth

  3. father-child-interaction

    The father-infant-interaction is investigated during the same video as the paternal sensitivity using Mannheim Rating Scales by a blinded psychologist. Mannheim Rating Scale is a good validated standardized observation instrument. Stimulation and response from the father as well from the infant are being recorded. Different communication channels can be used by father and child (vocal, facial or motor). All behaviors are analyzed at intervals of five seconds (event coding). The values are formed from the sum of the coded events. The scale ranges from 0 to 60. If there is no interaction, the scale is 0. If there is an interaction in each interval (every 5 seconds in a 5 minute videotape), the scale is 60. The father-child interaction is better if the scale is higher.

    Measured: six months of age

  4. paternal depression

    Paternal depression is assessed with the Edinburgh Postnatal Depression Scale (EPDS). It is a self-report questionnaire to measure depressive symptoms especially after birth and it consists of 10 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The point values are summed to a total measure score. The score ranges from 0 to 30. Zero points represents no symptoms of depression, a score of 13 or higher is interpreted to indicate a risk of depression.

    Measured: first week, 3 and 6 months after birth

  5. socioeconomic status

    There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation

    Measured: first week after birth

  6. social support

    Social support is assessed with the short German version of the questionnaire on social support (F-SozU K-22). The questionnaire records the subjectively perceived or anticipated support from the social environment. There are 22 items and the test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). The scale ranges from a minimum of 22 points to a maximum of 110 points. The higher the score, the better the subjectively perceived or anticipated support.

    Measured: three months after birth

  7. impact of event scale

    Symptoms for post-traumatic stress is assessed with the impact of event scale - revised (IES-R). It is a self-report questionnaire and consists of 22 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last week). The sub-scale values are summed by the corresponding sub-scale items. The three sub-scales are: intrusion, avoidance and hyperarousal. The overall result is calculated by a formula. The score ranges from -4,36 to 2,99. A result above 0 is interpreted to indicate a risk for post-traumatic stress disorder.

    Measured: six months after birth

  8. Parental Bonding

    Parental Bonding is assessed with the parental bonding questionnaire (PBQ). It consists of 25 items and each item is rated on a scale from 0 to 3 points (response range from "very like" to "very unlike"). There are four sub-scales and the point values of each sub-scale are summed to a total measure score. The four sub-scales are: impaired bonding, rejection and anger, anxiety about care, risk of abuse. The higher the score, the higher the risk of a disorder in each area of the sub-scale.

    Measured: first week, 3 and 6 months after birth

  9. Parental Stress

    Parental stress is assessed with the German form of the parenting stress index (PSI).

    It consists of 48 items. The test person can indicate the degree of agreement on a five-level Likert scale (from 1 = does not apply to 5 = applies completely). There are 12 subscales, each consisting of 4 items and the points on the Likert scale are added. In each subscale there can be a minimum of 4 and a maximum of 20 points. The higher the score, the higher the parental stress.

    Measured: six months after birth

  10. Parental Stress

    The perceived parental stress is assessed by the German version from the perceived stress scale (PSS-10). It is a self-report questionnaire to measure symptoms of stress and it consists of 10 questions. For each question the response choice are assigned point values (how often a symptom occurred during the last month). There are two subscales (perceived helplessness and perceived self-efficacy). The subscale perceived self-efficacy are reversed score for the total score. The point values of both subscales are summed to a total measure score. The score ranges from 0 to 50. Zero points represents no symptoms of stress, higher scores reflect greater levels of stress.

    Measured: first week, 3 and 6 months after birth

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2023
  2. Study start1 Oct 2024
  3. Primary completion30 Jun 2025 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05969431
Sponsor's protocol ID
23-114058
Status last verified
Nov 2024
First submitted
24 Jul 2023
Last updated
27 Nov 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Stress, Psychological and Father-Child Relations, run by University of Cologne at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 27 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Eva Heine, Dr. med. (004922147885663, eva.heine@uk-koeln.de), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

hair cortisol level (time frame: first week after birth, 3 and 6 months after birth). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2024.

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