Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age1-7
SponsorUniversity of Cologne
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial population
Fathers of newborns born at the university hospital of Cologne
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
measurement of cortisol level
Diagnostic testWe 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.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: fathers of mature infants1 intervention
Group B: fathers of moderate and late preterm infants1 intervention
Group C: fathers of very low birth weight preterm infants1 intervention
Trial outcomes
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.
Time frame
first week after birth, 3 and 6 months after birthSecondary outcomes
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.
Time frame
first week after birth, 3 and 6 months after birth2
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.
Time frame
6 months after birth3
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.
Time frame
six months of age4
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.
Time frame
first week, 3 and 6 months after birthSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of Cologne
Lead sponsor
University of Siegen
Collaborator
Source ClinicalTrials.gov