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/NCT05975203</url>
    </required_header>
    <id_info>
      <org_study_id>22-1419</org_study_id>
      <nct_id>NCT05975203</nct_id>
    </id_info>
    <brief_title>Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants</brief_title>
    <acronym>COSY</acronym>
    <official_title>Continuous Delivery Room Skin-to-skin-study for Moderate and Late Preterm Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Cologne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </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 randomized controlled trial is to compare the effect of direct skin-to-skin&#xD;
        contact in moderate and late preterm infants. The main questions it aims to answer are:&#xD;
  &#xD;
          -  does skin-to-skin contact in moderate and late preterm infants influence gene expression&#xD;
             in the stress signaling pathway?&#xD;
  &#xD;
          -  does skin-to-skin contact in moderate and late preterm infants improve the short- and&#xD;
             long-term outcome?&#xD;
  &#xD;
        Participants will either get immediate separation after vaginal birth or receive immediate&#xD;
        skin-to-skin contact. Researchers will compare these two groups to answer the proposed&#xD;
        questions.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The planned study investigates prospectively the effect of early intervention (skin-to-skin&#xD;
        contact in the delivery room) in moderate and late preterm infants on neonatal programming by&#xD;
        determining gene expression in the stress signaling pathway. The working hypothesis of our&#xD;
        project is that the intervention will affect gene expression in a way that subsequently leads&#xD;
        to better long-term psycho-social and neurological development of these preterm infants. The&#xD;
        study aims to improve the understanding of the correlation of behavioral and epigenetic&#xD;
        parameters and prove the underlying hypothesis of a novel mechanistic link between immediate&#xD;
        skin-to-skin contact in the delivery room and life-long stress tolerance.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 4, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2026</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
      <masking_description>Due to the nature of the intervention blinding of participant and care provider is not possible. The investigators are part of the care providing team.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>gene expression in candidate genes of the stress signalling pathway</measure>
      <time_frame>36 to 72 hours after birth</time_frame>
      <description>DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>gene expression in candidate genes of the stress signalling pathway</measure>
      <time_frame>corrected 6 months of age</time_frame>
      <description>DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>gene expression in candidate genes of the stress signalling pathway</measure>
      <time_frame>corrected 24 months of age</time_frame>
      <description>DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>mother-child-interaction</measure>
      <time_frame>corrected 6 months of age</time_frame>
      <description>Mother-child-interaction is investigated using Mannheim Rating Scales. Therefore a five-minute-videotape of the mother changing the infant's diapers and playing with the infant is used.&#xD;
  Mannheim Rating Scales is a good validated standardized observation instrument. Stimulation and response from the mother as well from the infant are being recorded. Different communication channels can be used by mother and child (vocal, facial or motor).&#xD;
  All behaviors are analysed at intervals of five seconds (event coding). Then the values are formed from the sum of the coded events.&#xD;
  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 mother-child interaction is better if the scale is higher.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>General Movements</measure>
      <time_frame>corrected 3 months of age</time_frame>
      <description>The early infant development will be analyzed by general movements assessment by Prechtl. It is a validated diagnostic tool for the functional assessment of the young nervous system.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>maternal depression</measure>
      <time_frame>at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age</time_frame>
      <description>Maternal 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>social support</measure>
      <time_frame>at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age</time_frame>
      <description>Social support is assessed with the short version of the German questionnaire for social support (Fragebogen zur sozialen Unterstützung, questionnaire on social support) scale (F-SozU K-22).&#xD;
  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>socio-economic status</measure>
      <time_frame>at inpatient discharge (assessed from 3 to 60 days of life)</time_frame>
      <description>There will be a question to the household income per month and the parents' highest school-leaving certificate as well as the housing situation.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>breastfeeding</measure>
      <time_frame>at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age</time_frame>
      <description>There will be a question about breastfeeding.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>impact of event scale</measure>
      <time_frame>corrected 6 months of age</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 of post-traumatic stress disorder.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Parental Bonding</measure>
      <time_frame>corrected 6 and 24 months of age</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>corrected 6 and 24 months of age</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>
    <secondary_outcome>
      <measure>reactivity of hypothalamic-pituitary-adrenal-axis</measure>
      <time_frame>36 to 72 hours after birth and corrected 24 months of age</time_frame>
      <description>Salivary cortisol is measured before and 20 minutes after heel lance, respectively after a stressful testing. The saliva is collected by a small cotton roll, which is placed in the infants' mouth. The cortisol is assayed in duplicate using an immunoassay, which is a validated test.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Preterm Birth</condition>
    <condition>Mother-Infant Interaction</condition>
    <condition>Infant Development</condition>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>skin-to-skin contact</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>skin-to-skin contact</intervention_name>
      <description>Immediately after delivery the infant will receive skin-to-skin contact with the mother.</description>
      <arm_group_label>skin-to-skin contact</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  preterm birth between gestational age of 32 0/7 and 36 6/7 weeks&#xD;
  &#xD;
            -  first child&#xD;
  &#xD;
            -  vaginal delivery&#xD;
  &#xD;
            -  singleton&#xD;
  &#xD;
            -  informed consent before birth&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  malformations or syndromes of the infant&#xD;
  &#xD;
            -  resuscitation of the infant&#xD;
  &#xD;
            -  maternal psychological or severe physical illness&#xD;
  &#xD;
            -  lack of German language skills&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</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>Katrin Mehler, PD Dr.</last_name>
      <phone>004922147885663</phone>
      <email>katrin.mehler@uk-koeln.de</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Angela Kribs, PD Dr.</last_name>
      <phone>004922147885663</phone>
      <email>angela.kribs@uk-koeln.de</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University hospital of Cologne, Department of Neonatology</name>
        <address>
          <city>Cologne</city>
          <state>Northrhine-westfalia</state>
          <zip>50931</zip>
          <country>Germany</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Katrin Mehler, MD</last_name>
        <phone>004922147885663</phone>
        <email>katrin.mehler@uk-koeln.de</email>
      </contact>
      <contact_backup>
        <last_name>Angela Kribs, MD</last_name>
        <phone>004922147885663</phone>
        <email>angela.kribs@uk-koeln.de</email>
      </contact_backup>
      <investigator>
        <last_name>Katrin Mehler, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Angela Kribs, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <reference>
      <citation>Mehler K, Hucklenbruch-Rother E, Trautmann-Villalba P, Becker I, Roth B, Kribs A. Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial. Acta Paediatr. 2020 Mar;109(3):518-526. doi: 10.1111/apa.14975. Epub 2019 Sep 16.</citation>
      <PMID>31423649</PMID>
    </reference>
    <reference>
      <citation>Hucklenbruch-Rother E, Vohlen C, Mehdiani N, Keller T, Roth B, Kribs A, Mehler K. Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes. Psychoneuroendocrinology. 2020 Dec;122:104883. doi: 10.1016/j.psyneuen.2020.104883. Epub 2020 Sep 24.</citation>
      <PMID>33027708</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>August 1, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 3, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 7, 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>
    <keyword>preterm behavioral epigenetics</keyword>
    <keyword>skin-to-skin contact</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Premature Birth</mesh_term>
    </condition_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/NCT05975203
  org study id: 22-1419
  nct id: NCT05975203
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this randomized controlled trial is to compare the effect of direct skin-to-skin
        contact in moderate and late preterm infants. The main questions it aims to answer are:
  
          -  does skin-to-skin contact in moderate and late preterm infants influence gene expression
             in the stress signaling pathway?
  
          -  does skin-to-skin contact in moderate and late preterm infants improve the short- and
             long-term outcome?
  
        Participants will either get immediate separation after vaginal birth or receive immediate
        skin-to-skin contact. Researchers will compare these two groups to answer the proposed
        questions.
  The planned study investigates prospectively the effect of early intervention (skin-to-skin
        contact in the delivery room) in moderate and late preterm infants on neonatal programming by
        determining gene expression in the stress signaling pathway. The working hypothesis of our
        project is that the intervention will affect gene expression in a way that subsequently leads
        to better long-term psycho-social and neurological development of these preterm infants. The
        study aims to improve the understanding of the correlation of behavioral and epigenetic
        parameters and prove the underlying hypothesis of a novel mechanistic link between immediate
        skin-to-skin contact in the delivery room and life-long stress tolerance.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  masking description: Due to the nature of the intervention blinding of participant and care provider is not possible. The investigators are part of the care providing team.
  measure: gene expression in candidate genes of the stress signalling pathway
  time frame: 36 to 72 hours after birth
  description: DNA will be extracted from peripheral white blood cells and mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
  measure: gene expression in candidate genes of the stress signalling pathway
  time frame: corrected 6 months of age
  description: DNA and RNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor. Furthermore a whole-genome methylation will be analysed.
  measure: gene expression in candidate genes of the stress signalling pathway
  time frame: corrected 24 months of age
  description: DNA will be extracted from mucosal epithelial cells. The expression of candidate genes of the stress signaling pathways are investigated. The candidate genes are glucocorticoid receptor (NR3C1), corticotropin releasing hormone (CRH), corticotropin-releasing hormone receptor 1 and 2 (CRHR1/2), serotonin transporter (slc6a4), vasopressin and brain-derived neurotrophic factor.
  measure: mother-child-interaction
  time frame: corrected 6 months of age
  description: Mother-child-interaction is investigated using Mannheim Rating Scales. Therefore a five-minute-videotape of the mother changing the infant's diapers and playing with the infant is used.
  Mannheim Rating Scales is a good validated standardized observation instrument. Stimulation and response from the mother as well from the infant are being recorded. Different communication channels can be used by mother and child (vocal, facial or motor).
  All behaviors are analysed at intervals of five seconds (event coding). Then 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 mother-child interaction is better if the scale is higher.
  measure: General Movements
  time frame: corrected 3 months of age
  description: The early infant development will be analyzed by general movements assessment by Prechtl. It is a validated diagnostic tool for the functional assessment of the young nervous system.
  measure: maternal depression
  time frame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 6 and 24 months of age
  description: Maternal 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: social support
  time frame: at inpatient discharge (assessed from 3 to 60 days of life), corrected 24 months of age
  description: Social support is assessed with the short version of the German questionnaire for social support (Fragebogen zur sozialen Unterstützung, questionnaire on social support) scale (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: socio-economic status
  time frame: at inpatient discharge (assessed from 3 to 60 days of life)
  description: There will be a question to the household income per month and the parents' highest school-leaving certificate as well as the housing situation.
  measure: breastfeeding
  time frame: at inpatient discharge (assessed from 3 to 60 days of life) and corrected six months of age
  description: There will be a question about breastfeeding.
  measure: impact of event scale
  time frame: corrected 6 months of age
  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 of post-traumatic stress disorder.
  measure: Parental Bonding
  time frame: corrected 6 and 24 months of age
  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: corrected 6 and 24 months of age
  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.
  measure: reactivity of hypothalamic-pituitary-adrenal-axis
  time frame: 36 to 72 hours after birth and corrected 24 months of age
  description: Salivary cortisol is measured before and 20 minutes after heel lance, respectively after a stressful testing. The saliva is collected by a small cotton roll, which is placed in the infants' mouth. The cortisol is assayed in duplicate using an immunoassay, which is a validated test.
  arm group label: Standard care
  arm group type: No Intervention
  description: After delivery the infant will be separated from the mother and placed on a primary care unit in another room to monitor the cardiopulmonary adaption for at least 20 minutes.
  arm group label: skin-to-skin contact
  arm group type: Experimental
  description: After delivery the infant will be put skin-to-skin on the mother's breast in comfort position for 60 minutes. The cardiopulmonary adaption will be monitored and supervised by the attending neonatologist and nurse.
  intervention type: Procedure
  intervention name: skin-to-skin contact
  description: Immediately after delivery the infant will receive skin-to-skin contact with the mother.
  arm group label: skin-to-skin contact
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Katrin Mehler, PD Dr.
  role: Principal Investigator
  affiliation: University of Cologne
  last name: Katrin Mehler, PD Dr.
  phone: 004922147885663
  email: katrin.mehler@uk-koeln.de
  last name: Angela Kribs, PD Dr.
  phone: 004922147885663
  email: angela.kribs@uk-koeln.de
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: Germany
  citation: Mehler K, Hucklenbruch-Rother E, Trautmann-Villalba P, Becker I, Roth B, Kribs A. Delivery room skin-to-skin contact for preterm infants-A randomized clinical trial. Acta Paediatr. 2020 Mar;109(3):518-526. doi: 10.1111/apa.14975. Epub 2019 Sep 16.
  PMID: 31423649
  citation: Hucklenbruch-Rother E, Vohlen C, Mehdiani N, Keller T, Roth B, Kribs A, Mehler K. Delivery room skin-to-skin contact in preterm infants affects long-term expression of stress response genes. Psychoneuroendocrinology. 2020 Dec;122:104883. doi: 10.1016/j.psyneuen.2020.104883. Epub 2020 Sep 24.
  PMID: 33027708
  responsible party type: Principal Investigator
  investigator affiliation: University of Cologne
  investigator full name: Katrin Mehler
  investigator title: Associate Professor
  mesh term: Premature Birth
  sharing ipd: No