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.
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
- Conditions the study is for
- Stress, Psychological, Father-Child Relations, Premature Birth
- 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.
Germany1 site, 1 recruiting
- Recruiting
University Hospital of Cologne
Cologne, Northrhine-westfalia, 50931
Katrin Mehler, PhD, 004922147885663, katrin.mehler@uk-koeln.de
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 group | Role | What they receive |
|---|---|---|
| fathers of mature infants | Fathers of newborns' above 37 weeks of gestation Receives: 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. Receives: 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. Receives: Diagnostic Test: measurement of cortisol level |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
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
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
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
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
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
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
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
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
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.
- First posted1 Aug 2023
- Study start1 Oct 2024
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Cologne
- Sponsor type
- University, hospital or other
- Collaborators
- University of Siegen
- Responsible party
- Principal investigator, Katrin Mehler, University of Cologne
- Investigators
- Katrin Mehler, PD Dr., Principal investigator, University of Cologne
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
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
- ClinicalTrials.gov ID
- NCT05969431
- Acronym / sponsor ID
- 23-114058
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of CologneUniversity, hospital or other
- Collaborators
- University of Siegen
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 1 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| fathers of mature infants | – | Diagnostic Test: measurement of cortisol levelFathers of newborns' above 37 weeks of gestation |
| fathers of moderate and late preterm infants | – | Diagnostic Test: measurement of cortisol levelFathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation. |
| fathers of very low birth weight preterm infants | – | Diagnostic Test: measurement of cortisol levelFathers 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. |
Who may qualify
- Ages
- 1 day to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Fathers of newborns born at the university hospital of Cologne
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| measurement of cortisol levelAlso: questionnaireWe 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. | Diagnostic test | fathers of mature infants, fathers of moderate and late preterm infants, fathers of very low birth weight preterm infants |
Primary outcome
hair cortisol level
Time frame: first week after birth, 3 and 6 months after birth
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.
10 secondary outcomes
Cortisone, testosterone, progesterone, dehydroepiandrosterone level in the paternal hair
Time frame: first week after birth, 3 and 6 months after birth
paternal sensitivity
Time frame: 6 months after birth
father-child-interaction
Time frame: six months of age
paternal depression
Time frame: first week, 3 and 6 months after birth
socioeconomic status
Time frame: first week after birth
social support
Time frame: three months after birth
impact of event scale
Time frame: six months after birth
Parental Bonding
Time frame: first week, 3 and 6 months after birth
Parental Stress
Time frame: six months after birth
Parental Stress
Time frame: first week, 3 and 6 months after birth
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Katrin Mehler, PD Dr. principal investigator
University of Cologne
1 site in 1 country: see every site and its status.
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.