<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/NCT02996799</url>
  </required_header>
  <id_info>
    <org_study_id>409-16</org_study_id>
    <nct_id>NCT02996799</nct_id>
  </id_info>
  <brief_title>Deferred Cord Clamping Compared to Umbilical Cord Milking in Preterm Infants</brief_title>
  <official_title>Efficacy and Safety of Deferred Umbilical Cord Clamping Compared to Umbilical CordMilking in Preterm Infants: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      For preterm infants, deferred cord clamping has been shown to improve both short term and&#xD;
      long-term neonatal outcomes without an established harm for both the mother and her&#xD;
      infant.The interference with resuscitative measures for the neonate or the mother is a risk&#xD;
      that continued to hamper the implementation of delayed cord clamping in many centers around&#xD;
      the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method&#xD;
      of placental transfusion that involves milking of the umbilical cord.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and&#xD;
      in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord&#xD;
      milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to&#xD;
      umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood&#xD;
      pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking&#xD;
      arm.However, concerns have been raised with regard to rapid infusion of large volume of blood&#xD;
      in relatively shorter time predisposing to hyperperfusion injury including intraventricular&#xD;
      hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk&#xD;
      of neurological injury. It has, though, advantage of shorter timeframe allowing for effective&#xD;
      resuscitation of preterm neonates to start as soon as possible. Thus, with countering&#xD;
      advantages and disadvantages, the practice has not been adopted at most places. The authors&#xD;
      planned to conduct a randomized clinical trail to compare the efficacy and safety of&#xD;
      umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks&#xD;
      gestation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>January 2017</start_date>
  <completion_date type="Anticipated">June 2023</completion_date>
  <primary_completion_date type="Anticipated">June 2023</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>Supportive Care</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intraventricular haemorrhage</measure>
    <time_frame>twenty eight days</time_frame>
    <description>Any IVH diagnosed by cranial ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Need for resuscitation</measure>
    <time_frame>one hour</time_frame>
    <description>Cardiac compression or medications at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar score at one minute</measure>
    <time_frame>one minute after delivery</time_frame>
    <description>Calculated Apgar score at one minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Apgar score at 5 minutes</measure>
    <time_frame>5 minutes after delivery</time_frame>
    <description>Calculated Apgar score at 5 minutes</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The need for blood transfusion during hospital stay</measure>
    <time_frame>one month</time_frame>
    <description>The number of blood transfusions during hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous Hgb</measure>
    <time_frame>2 days</time_frame>
    <description>Hgb at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Venous hematocrit</measure>
    <time_frame>2 days</time_frame>
    <description>Hematocrit at birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bilirubin level</measure>
    <time_frame>24 hours after birth</time_frame>
    <description>First bilirubin level after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum bilirubin level</measure>
    <time_frame>first week of life</time_frame>
    <description>Highest bilirubin level</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Polycythemia</measure>
    <time_frame>first 48 hours after birth</time_frame>
    <description>If venous hematocrit more than 65%</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Respiratory distress syndrome</measure>
    <time_frame>48 hours after birth</time_frame>
    <description>The need for surfactant administration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen dependency</measure>
    <time_frame>first 28 days after birth and 36 weeks corrected age</time_frame>
    <description>first 28 days after birth and/or 36 weeks corrected age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need for volume administration</measure>
    <time_frame>24 hours after birth</time_frame>
    <description>Need for bolus administration first 24 hours after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Use of inotropes</measure>
    <time_frame>First 24 hours</time_frame>
    <description>Use of any kind of inotropes in the first 24 hours</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Necrotizing enterocolitis</measure>
    <time_frame>one month</time_frame>
    <description>Bell stage II or more</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality in hospital</measure>
    <time_frame>one month</time_frame>
    <description>Death before discharge</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sepsis</measure>
    <time_frame>one month</time_frame>
    <description>Positive blood culture</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal mortality</measure>
    <time_frame>2 weeks</time_frame>
    <description>Maternal death after delivery in hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post partum hemorrhage</measure>
    <time_frame>one day</time_frame>
    <description>Maternal estimated blood loss more than 500 mls in the first 24 hours after birth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maternal need for blood transfusion</measure>
    <time_frame>First 48 hours after delivery</time_frame>
    <description>Maternal blood transfusion in the first 48 hours after delivery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of third stage</measure>
    <time_frame>24 hours</time_frame>
    <description>The time from delivery of the infant until delivery of placenta</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">180</enrollment>
  <condition>PreTerm Birth</condition>
  <condition>Intraventricular Hemorrhage</condition>
  <arm_group>
    <arm_group_label>Deferred Cord Clamping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Umbilical cord milking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Umbilical cord milking</intervention_name>
    <description>Milking of the umbilical cord at delivery</description>
    <arm_group_label>Umbilical cord milking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Preterm infants &lt; 32 weeks gestation confirmed by first trimester US&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Any proven or suspected congenital or chromosomal abnormalities&#xD;
&#xD;
          -  Placenta previa or abruption&#xD;
&#xD;
          -  Cord prolapse&#xD;
&#xD;
          -  Known Rh sensitization&#xD;
&#xD;
          -  Fetal hydrops&#xD;
&#xD;
          -  Monochorionic multiples&#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>Heidi Al-Wassia, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>King Abdulaziz University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Heidi Al-Wassia</last_name>
    <phone>966544800441</phone>
    <email>halwassia@kau.edu.sa</email>
  </overall_contact>
  <location>
    <facility>
      <name>King Abdulaziz University Hospital</name>
      <address>
        <city>Jeddah</city>
        <country>Saudi Arabia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heidi Al-Wassia</last_name>
      <email>halwassia@kau.edu.sa</email>
    </contact>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 3, 2016</study_first_submitted>
  <study_first_submitted_qc>December 14, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 19, 2016</study_first_posted>
  <last_update_submitted>August 16, 2022</last_update_submitted>
  <last_update_submitted_qc>August 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Heidi Al-Wassia</investigator_full_name>
    <investigator_title>Assistant 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>Hemorrhage</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available upon request</ipd_time_frame>
    <ipd_access_criteria>Shared files</ipd_access_criteria>
  </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/NCT02996799
org study id: 409-16
nct id: NCT02996799
lead sponsor: 
has dmc: Yes
For preterm infants, deferred cord clamping has been shown to improve both short term and
      long-term neonatal outcomes without an established harm for both the mother and her
      infant.The interference with resuscitative measures for the neonate or the mother is a risk
      that continued to hamper the implementation of delayed cord clamping in many centers around
      the world.For that reason, the evidence now is seeking a time-honored, yet not adopted method
      of placental transfusion that involves milking of the umbilical cord.
Contrary to delayed cord clamping, milking of the umbilical cord is done at a faster rate and
      in shorter time.Recent evidence has demonstrated the efficacy and safety of umbilical cord
      milking for both term and preterm infants.A newer evidence comparing delayed cord clamping to
      umbilical cord milking in preterm infants demonstrated a higher initial hemoglobin, blood
      pressure and systemic blood flow in preterm infants allocated to the umbilical cord milking
      arm.However, concerns have been raised with regard to rapid infusion of large volume of blood
      in relatively shorter time predisposing to hyperperfusion injury including intraventricular
      hemorrhage. This is particularly problematic for preterm neonates as they are at higher risk
      of neurological injury. It has, though, advantage of shorter timeframe allowing for effective
      resuscitation of preterm neonates to start as soon as possible. Thus, with countering
      advantages and disadvantages, the practice has not been adopted at most places. The authors
      planned to conduct a randomized clinical trail to compare the efficacy and safety of
      umbilical cord milking to deferred cord clamping in preterm infants less than 32 weeks
      gestation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Double (Care Provider, Outcomes Assessor)
measure: Intraventricular haemorrhage
time frame: twenty eight days
description: Any IVH diagnosed by cranial ultrasound
measure: Need for resuscitation
time frame: one hour
description: Cardiac compression or medications at birth
measure: Apgar score at one minute
time frame: one minute after delivery
description: Calculated Apgar score at one minute
measure: Apgar score at 5 minutes
time frame: 5 minutes after delivery
description: Calculated Apgar score at 5 minutes
measure: The need for blood transfusion during hospital stay
time frame: one month
description: The number of blood transfusions during hospital stay
measure: Venous Hgb
time frame: 2 days
description: Hgb at birth
measure: Venous hematocrit
time frame: 2 days
description: Hematocrit at birth
measure: Bilirubin level
time frame: 24 hours after birth
description: First bilirubin level after birth
measure: Maximum bilirubin level
time frame: first week of life
description: Highest bilirubin level
measure: Polycythemia
time frame: first 48 hours after birth
description: If venous hematocrit more than 65%
measure: Respiratory distress syndrome
time frame: 48 hours after birth
description: The need for surfactant administration
measure: Oxygen dependency
time frame: first 28 days after birth and 36 weeks corrected age
description: first 28 days after birth and/or 36 weeks corrected age
measure: Need for volume administration
time frame: 24 hours after birth
description: Need for bolus administration first 24 hours after birth
measure: Use of inotropes
time frame: First 24 hours
description: Use of any kind of inotropes in the first 24 hours
measure: Necrotizing enterocolitis
time frame: one month
description: Bell stage II or more
measure: Mortality in hospital
time frame: one month
description: Death before discharge
measure: Sepsis
time frame: one month
description: Positive blood culture
measure: Maternal mortality
time frame: 2 weeks
description: Maternal death after delivery in hospital
measure: Post partum hemorrhage
time frame: one day
description: Maternal estimated blood loss more than 500 mls in the first 24 hours after birth
measure: Maternal need for blood transfusion
time frame: First 48 hours after delivery
description: Maternal blood transfusion in the first 48 hours after delivery
measure: Length of third stage
time frame: 24 hours
description: The time from delivery of the infant until delivery of placenta
arm group label: Deferred Cord Clamping
arm group type: No Intervention
description: Neonate is held at the level of placenta (level of introitus (vaginal delivery ) and mother's thigh or operating table (C/S) and cord clamping is deferred for 60 seconds.
arm group label: Umbilical cord milking
arm group type: Experimental
description: Manually stripping 20cm of cord segment toward the umbilicus over a period of 2-3 seconds three times before cord clamping.
intervention type: Other
intervention name: Umbilical cord milking
description: Milking of the umbilical cord at delivery
arm group label: Umbilical cord milking
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Heidi Al-Wassia, MD
role: Principal Investigator
affiliation: King Abdulaziz University
last name: Heidi Al-Wassia
phone: 966544800441
email: halwassia@kau.edu.sa
facility: 
status: Recruiting
contact: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Heidi Al-Wassia
investigator title: Assistant Professor
mesh term: Premature Birth
mesh term: Hemorrhage
sharing ipd: Yes
ipd description: We are planning to publish all the data that we will collect. If other researchers have specific questions about the data, we are willing to answer and share if needed.
ipd info type: Study Protocol
ipd time frame: Data will be available upon request
ipd access criteria: Shared files