University Hospital of Cologne
Cologne, Northrhine-westfalia, 50931, Germany
Location status: Recruiting
NCT Number: NCT05969431
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.
Interested in participating?
Request Info1 day–7 day
All sexes
Observational
Cologne, Northrhine-westfalia, 50931, Germany
Location status: Recruiting
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).
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: first week after birth, 3 and 6 months after birth
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: 6 months after birth
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: six months of age
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: first week, 3 and 6 months after birth
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 after birth
There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation
Time frame: three months after birth
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.
Time frame: six months after birth
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.
Time frame: first week, 3 and 6 months after birth
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.
Time frame: six months after birth
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.
Time frame: first week, 3 and 6 months after birth
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.
Contact information is provided by the study sponsor or research team.
Eva Heine, Dr. med.
CONTACT
Katrin Mehler, PD Dr.
CONTACT
University of Cologne
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07295106
Behavior, Behavioral Symptoms
Perugia, PG, Italy
View Trial DetailsNCT06827028
Anxiety, Anxiety Disorders
Munich, Bavaria, Germany
View Trial DetailsNCT03791749
Behavior, Behavioral Symptoms
London, United Kingdom
View Trial DetailsNCT07727434
Anxiety, Anxiety Disorders
Istanbul, Turkey (Türkiye)
View Trial Details