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

Stress, Psychological Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05969431
• Other study ID #: 23-114058
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: April 28, 2025

Study information

• Verified date: December 2023
• Source: University of Cologne
• Contact: Eva Heine, Dr. med.
• Phone: 004922147885663
• Email: eva.heine[@]uk-koeln.de
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: April 28, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 7 Days

Eligibility

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

Related Conditions & MeSH terms

• Father-Child Relations
• Premature Birth
• Stress, Psychological

Intervention

Diagnostic Test:
• measurement of cortisol level
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Cologne	University of Siegen

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	paternal sensitivity	The paternal sensitivity will be measured during a five-minute-videotape of the father changing the infants' diapers and playing with the infant. It 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.	6 months after birth
Secondary	paternal depression	Paternal depression is assessed with the German long form of the Center for Epidemiological Studies Depression Scale (CES-D). It is a self-report questionnaire to measure depressive symptoms and it consists of 20 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 60. Zero points represents no symptoms of depression, a score of 15 or higher is interpreted to indicate a risk of depression.	first week, 3 and 6 months after birth
Secondary	socioeconomic status	There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation	first week after birth
Secondary	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.	three months after birth
Secondary	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.	six months after birth
Secondary	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.	six months after birth
Secondary	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.	six months after birth