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

Study Overview

• Status: Not yet recruiting
• Conditions: Stress, Psychological; Premature Birth; Father-Child Relations
• Intervention / Treatment: Diagnostic test: measurement of cortisol level

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Eva Heine, Dr. med.; Phone Number: 004922147885663; Email: eva.heine@uk-koeln.de
• Study Contact Backup: Name: Katrin Mehler, PD Dr.; Phone Number: 004922147885663; Email: katrin.mehler@uk-koeln.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Fathers of newborns born at the university hospital of Cologne

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
fathers of mature infants; Fathers of newborns' above 37 weeks of gestation	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.; Other Names: questionnaire
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; 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.; Other Names: questionnaire
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; 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.; Other Names: questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: University of Cologne
• Collaborators: University of Siegen
• Investigators: Principal Investigator: Katrin Mehler, PD Dr., University of Cologne

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): October 31, 2024
• Study Completion (Estimated): April 28, 2025

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 1, 2023

Study Record Updates

• Last Update Posted (Estimated): December 27, 2023
• Last Update Submitted That Met QC Criteria: December 23, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Pregnancy Complications; Obstetric Labor Complications; Obstetric Labor, Premature; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Stress, Psychological; Premature Birth; Anti-Inflammatory Agents; Hydrocortisone
• Other Study ID Numbers: 23-114058

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No