xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT05969431</url>
    </required_header>
    <id_info>
      <org_study_id>23-114058</org_study_id>
      <nct_id>NCT05969431</nct_id>
    </id_info>
    <brief_title>Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study</brief_title>
    <official_title>Hair Cortisol as Marker of Chronic Stress in Preterm and Term Fathers - Fathair-study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Cologne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Siegen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Cologne</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this observational study is to compare the paternal hair cortisol as a marker for&#xD;
        chronic stress in prematurely born children to maturely born children.&#xD;
  &#xD;
        The main questions it aims to answer are:&#xD;
  &#xD;
          -  How differ the cortisol level between groups?&#xD;
  &#xD;
          -  How change the cortisol level over time?&#xD;
  &#xD;
          -  Are there secondary outcomes associated to the cortisol level of fathers? Participants&#xD;
             will give a hair sample to analyse the cortisol level and fill out questionnaires at&#xD;
             three time points. At six months of the infant's age, the investigators will also&#xD;
             measure the paternal sensitivity.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        For expectant parents, the birth of a child is often a stressful situation. In the case of a&#xD;
        premature birth, the psychological stress is usually increased because the parents frequently&#xD;
        could not prepare for the birth. Therefore, the researcher would like to investigate this&#xD;
        stress of fathers of newborn children.&#xD;
  &#xD;
        For this purpose, the stress hormone cortisol in the fathers' hair will be analysed and&#xD;
        questionnaires on the fathers' mental health will be collected. Subsequently, the differences&#xD;
        between fathers of prematurely born and of maturely born children will be compared.&#xD;
  &#xD;
        The investigators will do the analyses at three time points: the first time point will be at&#xD;
        the first week after birth, the second three months and the third six months after birth. At&#xD;
        six months of the infant's age, additionally the paternal sensitivity will be measured.&#xD;
  &#xD;
        The compared groups will differ with respect to gestational age: Group 1 includes preterm&#xD;
        infants with a gestational age below 32 weeks and a birth weight &lt;1500 grams (very low&#xD;
        birthweight infants), group 2 preterm infants with a gestational age between 32 0/7 to 36 6/7&#xD;
        (moderate and late preterm infants) and group 3 consists of mature infants (over 37 weeks&#xD;
        gestational age).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 1, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 31, 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>hair cortisol level</measure>
      <time_frame>first week after birth, 3 and 6 months after birth</time_frame>
      <description>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.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>paternal sensitivity</measure>
      <time_frame>6 months after birth</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>paternal depression</measure>
      <time_frame>first week, 3 and 6 months after birth</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>socioeconomic status</measure>
      <time_frame>first week after birth</time_frame>
      <description>There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>social support</measure>
      <time_frame>three months after birth</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>impact of event scale</measure>
      <time_frame>six months after birth</time_frame>
      <description>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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Bonding</measure>
      <time_frame>six months after birth</time_frame>
      <description>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 &quot;very like&quot; to &quot;very unlike&quot;). 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.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Stress</measure>
      <time_frame>six months after birth</time_frame>
      <description>Parental stress is assessed with the German form of the parenting stress index (PSI).&#xD;
  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.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Stress, Psychological</condition>
    <condition>Father-Child Relations</condition>
    <condition>Premature Birth</condition>
    <arm_group>
      <arm_group_label>fathers of mature infants</arm_group_label>
      <description>Fathers of newborns' above 37 weeks of gestation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>fathers of moderate and late preterm infants</arm_group_label>
      <description>Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>fathers of very low birth weight preterm infants</arm_group_label>
      <description>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.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>measurement of cortisol level</intervention_name>
      <description>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.</description>
      <arm_group_label>fathers of mature infants</arm_group_label>
      <arm_group_label>fathers of moderate and late preterm infants</arm_group_label>
      <arm_group_label>fathers of very low birth weight preterm infants</arm_group_label>
      <other_name>questionnaire</other_name>
    </intervention>
    <biospec_retention>Samples Without DNA</biospec_retention>
    <biospec_descr>
      <textblock>
        A hair sample will be taken from the back of the father's head (a thin strand of hair,&#xD;
        approximately a total diameter of 3-5 mm). From this sample only the cortisol level will be&#xD;
        measured.&#xD;
      </textblock>
    </biospec_descr>
    <eligibility>
      <study_pop>
        <textblock>
          Fathers of newborns born at the university hospital of Cologne&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Premature or mature infant (22 0/7 to 42 0/7 weeks of gestation)&#xD;
  &#xD;
            -  For mature infants (37 0/7 to 42 0/7 weeks of gestation) undisturbed neonatal period&#xD;
  &#xD;
            -  No severe malformations or genetic diseases of the newborn child&#xD;
  &#xD;
            -  Sufficient knowledge of German of the father&#xD;
  &#xD;
            -  written consent of the custodial parents&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  adoptive or foster paternity&#xD;
  &#xD;
            -  hair length below 3 cm at the posterior vertex region of the back of the father's head&#xD;
  &#xD;
            -  endocrine disorders, especially of the adrenocortical system (e.g. Cushing syndrome,&#xD;
               adrenal insufficiency)&#xD;
  &#xD;
            -  taking steroidal medications or other drugs that affect the activity of the&#xD;
               hypothalamic-pituitary-adrenocortical system&#xD;
  &#xD;
            -  paternal psychological or severe physical illness&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>7 Days</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Katrin Mehler, PD Dr.</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Cologne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Eva Heine, Dr. med.</last_name>
      <phone>004922147885663</phone>
      <email>eva.heine@uk-koeln.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Katrin Mehler, PD Dr.</last_name>
      <phone>004922147885663</phone>
      <email>katrin.mehler@uk-koeln.de</email>
    </overall_contact_backup>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 24, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>August 1, 2023</last_update_submitted>
    <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 3, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Cologne</investigator_affiliation>
      <investigator_full_name>Katrin Mehler</investigator_full_name>
      <investigator_title>Associate Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
      <mesh_term>Stress, Psychological</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hydrocortisone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT05969431
  org study id: 23-114058
  nct id: NCT05969431
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  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.
  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).
  observational model: Cohort
  time perspective: Prospective
  measure: hair cortisol level
  time frame: first week after birth, 3 and 6 months after birth
  description: 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.
  measure: paternal sensitivity
  time frame: 6 months after birth
  description: 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.
  measure: paternal depression
  time frame: first week, 3 and 6 months after birth
  description: 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.
  measure: socioeconomic status
  time frame: first week after birth
  description: There will be questions to the household income per month, the parents' highest school-leaving certificate and the housing situation
  measure: social support
  time frame: three months after birth
  description: 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.
  measure: impact of event scale
  time frame: six months after birth
  description: 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.
  measure: Parental Bonding
  time frame: six months after birth
  description: 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.
  measure: Parental Stress
  time frame: six months after birth
  description: 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.
  arm group label: fathers of mature infants
  description: Fathers of newborns' above 37 weeks of gestation
  arm group label: fathers of moderate and late preterm infants
  description: Fathers of moderate and late preterm infants, i.e. gestational age from 32 0/7 to 36 6/7 weeks of gestation.
  arm group label: fathers of very low birth weight preterm infants
  description: 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.
  intervention type: Diagnostic Test
  intervention name: measurement of cortisol level
  description: 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.
  arm group label: fathers of mature infants
  arm group label: fathers of moderate and late preterm infants
  arm group label: fathers of very low birth weight preterm infants
  other name: questionnaire
  A hair sample will be taken from the back of the father's head (a thin strand of hair,
        approximately a total diameter of 3-5 mm). From this sample only the cortisol level will be
        measured.
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 7 Days
  healthy volunteers: Accepts Healthy Volunteers
  last name: Katrin Mehler, PD Dr.
  role: Principal Investigator
  affiliation: University of Cologne
  last name: Eva Heine, Dr. med.
  phone: 004922147885663
  email: eva.heine@uk-koeln.de
  last name: Katrin Mehler, PD Dr.
  phone: 004922147885663
  email: katrin.mehler@uk-koeln.de
  responsible party type: Principal Investigator
  investigator affiliation: University of Cologne
  investigator full name: Katrin Mehler
  investigator title: Associate Professor
  mesh term: Premature Birth
  mesh term: Stress, Psychological
  mesh term: Hydrocortisone
  sharing ipd: No