<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/NCT02187510</url>
  </required_header>
  <id_info>
    <org_study_id>CSPTNeonat2014_01</org_study_id>
    <nct_id>NCT02187510</nct_id>
  </id_info>
  <brief_title>Umbilical Cord Milking vs Delayed Cord Clamping in Preterm Infants Born by Cesarean Section</brief_title>
  <official_title>Umbilical Cord Milking Compared With Delayed Cord Clamping to Increase Plancental Transfusion in Preterm Infants Less Than 34 Weeks' Gestation Born by Cesarean Section. Randomised Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Corporacion Parc Tauli</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Corporacion Parc Tauli</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether the umbilical cord milking in preterm&#xD;
      infants born by cesarian section less than 34 weeks is more effective than delayed cord&#xD;
      clamping to obtain higher levels of hemoglobin.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">January 2016</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>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Haemoglobin</measure>
    <time_frame>1 hour and 24 hours at born</time_frame>
    <description>g/dl</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Apgar Score</measure>
    <time_frame>1 and 5 minutes</time_frame>
    <description>Basic score to mesure the newborn status. From 0 to 10.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Arterial pressure</measure>
    <time_frame>2, 6, 12, 24, 36 and 48 hours of life</time_frame>
    <description>Mean of systolic and dyastolic arterial pressure in mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orine volume</measure>
    <time_frame>24 and 48 hours of life</time_frame>
    <description>Total volume of orine at 24 and 48 hours of life. Total ml.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of vasopresors drugs</measure>
    <time_frame>24 hours of life</time_frame>
    <description>To use or not to use the vasopresors drugs during the first 24 hours of life</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of concentrate hematies transfusion</measure>
    <time_frame>participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)</time_frame>
    <description>Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraventricular hemorrhage</measure>
    <time_frame>participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)</time_frame>
    <description>Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bronchopulmonary dysplasia</measure>
    <time_frame>participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)</time_frame>
    <description>Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total intensive care unit stay</measure>
    <time_frame>Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)</time_frame>
    <description>Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hematocrit</measure>
    <time_frame>1 hour and 24 hours at born</time_frame>
    <description>In percentage</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Premature Infant</condition>
  <condition>Umbilical Cord</condition>
  <condition>Milking</condition>
  <condition>Delayed Clamping</condition>
  <arm_group>
    <arm_group_label>Umbilical cord milking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Delayed cord clamping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Umbilical cord milking</intervention_name>
    <description>Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.</description>
    <arm_group_label>Umbilical cord milking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Delayed cord clamping</intervention_name>
    <description>Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.</description>
    <arm_group_label>Delayed cord clamping</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants less than 34 weeks' gestation born by cesarean section&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to obtain informed consent from the mother state&#xD;
&#xD;
          -  Monochorionic-monoamniotic twin gestation&#xD;
&#xD;
          -  Placenta abruption&#xD;
&#xD;
          -  Uterine rupture&#xD;
&#xD;
          -  Transplacental cesarean&#xD;
&#xD;
          -  Hydrops fetalis&#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>Monica Domingo-Puiggros, MD</last_name>
    <role>Study Director</role>
    <affiliation>Corporacio Sanitaria Parc Tauli</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Corporacio Sanitaria Parc Tauli</name>
      <address>
        <city>Sabadell</city>
        <state>Barcelona</state>
        <zip>08208</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>June 6, 2014</study_first_submitted>
  <study_first_submitted_qc>July 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 11, 2014</study_first_posted>
  <last_update_submitted>April 27, 2016</last_update_submitted>
  <last_update_submitted_qc>April 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Corporacion Parc Tauli</investigator_affiliation>
    <investigator_full_name>Mònica Domingo Puiggròs</investigator_full_name>
    <investigator_title>Medical Doctor</investigator_title>
  </responsible_party>
  <keyword>Hemodynamics</keyword>
  <keyword>Premature Infant</keyword>
  <keyword>Umbilical cord</keyword>
  <keyword>Milking</keyword>
  <keyword>Delayed clamping</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <!-- 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/NCT02187510
org study id: CSPTNeonat2014_01
nct id: NCT02187510
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether the umbilical cord milking in preterm
      infants born by cesarian section less than 34 weeks is more effective than delayed cord
      clamping to obtain higher levels of hemoglobin.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: None (Open Label)
measure: Haemoglobin
time frame: 1 hour and 24 hours at born
description: g/dl
measure: Apgar Score
time frame: 1 and 5 minutes
description: Basic score to mesure the newborn status. From 0 to 10.
measure: Arterial pressure
time frame: 2, 6, 12, 24, 36 and 48 hours of life
description: Mean of systolic and dyastolic arterial pressure in mm Hg
measure: Orine volume
time frame: 24 and 48 hours of life
description: Total volume of orine at 24 and 48 hours of life. Total ml.
measure: Use of vasopresors drugs
time frame: 24 hours of life
description: To use or not to use the vasopresors drugs during the first 24 hours of life
measure: Number of concentrate hematies transfusion
time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
description: Total number of concentrate hematies transfusions during the hospital stay. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
measure: Intraventricular hemorrhage
time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
description: Presence of intraventricular hemorrhage mesured by cerebral ultrasound Degree of the hemorrhage by Papile
measure: Bronchopulmonary dysplasia
time frame: participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
description: Presence of Bronchopulmonary dysplasia and the degree, mesured by Spanish classification (M. Sanchez Luna)
measure: Total intensive care unit stay
time frame: Participants will be followed for the duration of hospital stay (from 2 weeks up to 3 months)
description: Mesured in days. The stay should vary depending of the gestacional age, from 2 weeks up to 3 months.
measure: Hematocrit
time frame: 1 hour and 24 hours at born
description: In percentage
arm group label: Umbilical cord milking
arm group type: Experimental
description: Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
arm group label: Delayed cord clamping
arm group type: Active Comparator
description: Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
intervention type: Procedure
intervention name: Umbilical cord milking
description: Once the preterm is born keep the baby from the mother's thighs. The obstetrician cord milking three times (2seconds/milking) taking the cord from the base 20cm respect towards the baby. Then clamp de cord.
arm group label: Umbilical cord milking
intervention type: Procedure
intervention name: Delayed cord clamping
description: Once the preterm is born the neonatologist keep the baby beside the mother at level of the operating table during 30 seconds without cord clamping. The baby is covered with a polythene bag and put a cap on his head. Then the obstetritian clamp the cord.
arm group label: Delayed cord clamping
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Monica Domingo-Puiggros, MD
role: Study Director
affiliation: Corporacio Sanitaria Parc Tauli
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Corporacion Parc Tauli
investigator full name: Mònica Domingo Puiggròs
investigator title: Medical Doctor
mesh term: Premature Birth