<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/NCT03827252</url>
  </required_header>
  <id_info>
    <org_study_id>PI2017_843_0008</org_study_id>
    <nct_id>NCT03827252</nct_id>
  </id_info>
  <brief_title>Respiratory Stability and Vegetative Coupling During Neonatal Skin-to-skin Care</brief_title>
  <acronym>PO-A-PO-PREMA</acronym>
  <official_title>Identification of Respiratory Stability Mechanisms During Skin-to-skin Care in Premature Infants in the Neonatal Intensive Care Unit: Infant-parent Vegetative Functions Coupling</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire, Amiens</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire, Amiens</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 main purpose of this study is to identify and to determine the involvement of&#xD;
      cardio-respiratory coordination mechanisms during SSC between the preterm infant and his&#xD;
      (her) parent.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on&#xD;
      the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the&#xD;
      infant's body temperature, better sleep organization, neurocognitive development and&#xD;
      cardio-respiratory stability, more strength in parent-infant affective relations, reduction&#xD;
      in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is&#xD;
      generalized in modern Neonatal Intensive Care Units as part of developmental care. However,&#xD;
      the mechanisms involved in SSC are not totally understood. The hypothesis in this study is&#xD;
      that the cardio-respiratory stability results partially from the intervention of the&#xD;
      coordination between cardiac and respiratory activities. These suppose the involvement of&#xD;
      complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with&#xD;
      chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers,&#xD;
      ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung&#xD;
      effectors. In this study the identification of these characteristics will be performed by&#xD;
      processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements,&#xD;
      perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring&#xD;
      systems. Each preterm infant included in the study will be explored twice, 5-10 days apart.&#xD;
      The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at&#xD;
      least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in&#xD;
      the study for 10 days at maximum. Inclusions in the study will last for a total period of 18&#xD;
      months and 10 days. The cardio-respiratory coordination will be assessed using coordigram&#xD;
      technique, corresponding to the proportion of time with &gt; 0.7 amplitude on spectral density.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 7, 2018</start_date>
  <completion_date type="Actual">September 12, 2020</completion_date>
  <primary_completion_date type="Actual">December 11, 2019</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>Cardio-respiratory coordination index</measure>
    <time_frame>10 days</time_frame>
    <description>Percentage of time during the recording that fulfills the criteria of coordination ( &gt; 0.7 amplitude of spectra in coordigram)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardio-respiratory coordination index by phase analysis technique</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between cardio-respiratory coordination index and SaO2</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation of temperatures (infant, parent) and cardio-respiratory coordination index</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">44</enrollment>
  <condition>Premature Infant</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature infant from 28weeks + 0 day to 36 weeks + 6 days gestational corrected age&#xD;
&#xD;
          -  At least 72 hours postnatal age&#xD;
&#xD;
          -  Benefiting skin-to-skin care&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severe congenital malformation and nervous system dysfunction (e.g., Ondine Sd)&#xD;
&#xD;
          -  Septic shock&#xD;
&#xD;
          -  Mechanical ventilation support&#xD;
&#xD;
          -  Severe pulmonary arterial hypertension&#xD;
&#xD;
          -  Analgesia morphinics at high dosage and curare&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Weeks</minimum_age>
    <maximum_age>36 Weeks</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>CHU Amiens-Picardie</name>
      <address>
        <city>Amiens</city>
        <zip>80000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>January 31, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 10, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>


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/NCT03827252
org study id: PI2017_843_0008
nct id: NCT03827252
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main purpose of this study is to identify and to determine the involvement of
      cardio-respiratory coordination mechanisms during SSC between the preterm infant and his
      (her) parent.
The skin to skin care (SSC) is a technique that proceeds by laying the neonate ventrally on
      the parent's chest. Many positive effects are recognized as due to SSC i.e, maintaining the
      infant's body temperature, better sleep organization, neurocognitive development and
      cardio-respiratory stability, more strength in parent-infant affective relations, reduction
      in neonatal and parental stress, more success in feeding with breast milk. Nowadays, SSC is
      generalized in modern Neonatal Intensive Care Units as part of developmental care. However,
      the mechanisms involved in SSC are not totally understood. The hypothesis in this study is
      that the cardio-respiratory stability results partially from the intervention of the
      coordination between cardiac and respiratory activities. These suppose the involvement of
      complex mechanisms of cardio-respiratory coordination including neuro-autonomous loops with
      chemoreceptors and baroreceptors, bulbar vasomotor and respiratory regulatory centers,
      ortho-parasympathetic neuronal and chemical pathways and cardiac, vascular and lung
      effectors. In this study the identification of these characteristics will be performed by
      processing signals of ECG, SaO2 (arterial oxygen saturation), respiratory movements,
      perfusion index, cutaneous and ambient temperature extracted from the clinical monitoring
      systems. Each preterm infant included in the study will be explored twice, 5-10 days apart.
      The explorations will be carried out on 3 steps: before (at least 30 minutes), during (at
      least 60 minutes) and after (≥ 60 minutes) the SSC session. Each patient will participate in
      the study for 10 days at maximum. Inclusions in the study will last for a total period of 18
      months and 10 days. The cardio-respiratory coordination will be assessed using coordigram
      technique, corresponding to the proportion of time with > 0.7 amplitude on spectral density.
observational model: Cohort
time perspective: Prospective
measure: Cardio-respiratory coordination index
time frame: 10 days
description: Percentage of time during the recording that fulfills the criteria of coordination ( > 0.7 amplitude of spectra in coordigram)
measure: Cardio-respiratory coordination index by phase analysis technique
time frame: 10 days
measure: Correlation between cardio-respiratory coordination index and SaO2
time frame: 10 days
measure: Correlation of temperatures (infant, parent) and cardio-respiratory coordination index
time frame: 10 days
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 28 Weeks
maximum age: 36 Weeks
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: France
responsible party type: Sponsor
mesh term: Premature Birth
sharing ipd: No