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/NCT05987202</url>
    </required_header>
    <id_info>
      <org_study_id>69HCL23_0779</org_study_id>
      <nct_id>NCT05987202</nct_id>
    </id_info>
    <brief_title>Betamethasone and Closure of Ductus Arteriosus</brief_title>
    <acronym>CELESTE</acronym>
    <official_title>Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hospices Civils de Lyon</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Hospices Civils de Lyon</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 ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its&#xD;
        persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with&#xD;
        significant morbidity and mortality: prolongation of respiratory assistance, pulmonary&#xD;
        haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death.&#xD;
  &#xD;
        PDA management is one of the most discussed aspects in neonatology. The treatment is either&#xD;
        conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or&#xD;
        pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or&#xD;
        catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the&#xD;
        most immature children. When medical treatment fails, surgical or endovascular treatment is&#xD;
        considered. However, these are associated with complications such as recurrent nerve lesion,&#xD;
        thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment&#xD;
        balances the expected benefits of CAP treatment against the risks associated with the&#xD;
        treatments for each patient.&#xD;
  &#xD;
        The main complication of CAP is the impossibility of weaning the patient from ventilatory&#xD;
        assistance. On the one hand because of PDA, but also very often because of the concomitant&#xD;
        development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to&#xD;
        assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at&#xD;
        ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th&#xD;
        week of life in accordance with current recommendations.&#xD;
  &#xD;
        The most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone&#xD;
        hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most&#xD;
        widely used product worldwide, but its use is associated with impaired postnatal growth and&#xD;
        suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some&#xD;
        effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has&#xD;
        been used less than the other products because it is not widely available in some countries.&#xD;
        Its advantage is that it can be given orally, but there is little published data on the&#xD;
        effect of BTM. In this context, it has been used in some neonatal units and have shown some&#xD;
        effectiveness.&#xD;
  &#xD;
        In the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005&#xD;
        and has been evaluated favorably, since it allows the child to be weaned from ventilatory&#xD;
        assistance. When using BTM, we observed not only a positive respiratory effect, but also DA&#xD;
        closure, reducing the need for ligation of the ductus arteriosus by surgery or&#xD;
        catheterization&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 1, 2023</start_date>
    <completion_date type="Anticipated">September 1, 2023</completion_date>
    <primary_completion_date type="Actual">June 1, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Number of children with favorable evolution of the CAP</measure>
      <time_frame>through study completion, an average of 6 months</time_frame>
      <description>Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">51</enrollment>
    <condition>Persistent Ductus Arteriosus</condition>
    <arm_group>
      <arm_group_label>Preterm infants born between January 1st, 2018 and December 31st, 2022</arm_group_label>
      <description>All infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>DA closure in a population of premature infants</intervention_name>
      <description>Evaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia</description>
      <arm_group_label>Preterm infants born between January 1st, 2018 and December 31st, 2022</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Infants born between january 2018 and December 2022, at a gestational age below 37 weeks,&#xD;
          hospitalized in the Neonatal unit of Croix-Rousse hospital, presenting an hemodynamically&#xD;
          significant DA and treated by BTM for bronchopulmonary dysplasia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          -  Inclusion Criteria :&#xD;
  &#xD;
                 -  born between January 2018 and December 2022&#xD;
  &#xD;
                 -  at a gestational age below 37 weeks,&#xD;
  &#xD;
                 -  hospitalized in the Neonatal unit of Croix-Rousse hospital,&#xD;
  &#xD;
                 -  presenting a hemodynamically significant DA&#xD;
  &#xD;
                 -  treated by BTM for bronchopulmonary dysplasia&#xD;
  &#xD;
            -  Exclusion Criteria :&#xD;
  &#xD;
                 -  Children having closed their ductus arteriosus before administration of the&#xD;
                    betamethasone course&#xD;
  &#xD;
                 -  Children who died before or during treatment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Year</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Service de Réanimation néonatale - Hôpital de la Croix Rousse</name>
        <address>
          <city>Lyon</city>
          <zip>69317</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jean-Charles PICAUD, Pr</last_name>
        <phone>04 72 00 41 24</phone>
        <phone_ext>+33</phone_ext>
        <email>jean-charles.picaud@chu-lyon.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Prematurity</keyword>
    <keyword>Ductus arteriosus</keyword>
    <keyword>Steroids</keyword>
    <keyword>Betamethasone</keyword>
    <keyword>Bronchopulmonary dysplasia</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Ductus Arteriosus, Patent</mesh_term>
    </condition_browse>
    <!-- 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/NCT05987202
  org study id: 69HCL23_0779
  nct id: NCT05987202
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its
        persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with
        significant morbidity and mortality: prolongation of respiratory assistance, pulmonary
        haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death.
  
        PDA management is one of the most discussed aspects in neonatology. The treatment is either
        conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or
        pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or
        catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the
        most immature children. When medical treatment fails, surgical or endovascular treatment is
        considered. However, these are associated with complications such as recurrent nerve lesion,
        thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment
        balances the expected benefits of CAP treatment against the risks associated with the
        treatments for each patient.
  
        The main complication of CAP is the impossibility of weaning the patient from ventilatory
        assistance. On the one hand because of PDA, but also very often because of the concomitant
        development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to
        assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at
        ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th
        week of life in accordance with current recommendations.
  
        The most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone
        hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most
        widely used product worldwide, but its use is associated with impaired postnatal growth and
        suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some
        effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has
        been used less than the other products because it is not widely available in some countries.
        Its advantage is that it can be given orally, but there is little published data on the
        effect of BTM. In this context, it has been used in some neonatal units and have shown some
        effectiveness.
  
        In the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005
        and has been evaluated favorably, since it allows the child to be weaned from ventilatory
        assistance. When using BTM, we observed not only a positive respiratory effect, but also DA
        closure, reducing the need for ligation of the ductus arteriosus by surgery or
        catheterization
  observational model: Cohort
  time perspective: Retrospective
  measure: Number of children with favorable evolution of the CAP
  time frame: through study completion, an average of 6 months
  description: Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM
  arm group label: Preterm infants born between January 1st, 2018 and December 31st, 2022
  description: All infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA
  intervention type: Other
  intervention name: DA closure in a population of premature infants
  description: Evaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia
  arm group label: Preterm infants born between January 1st, 2018 and December 31st, 2022
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 1 Year
  maximum age: N/A
  healthy volunteers: No
  facility: 
  status: Recruiting
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Ductus Arteriosus, Patent