<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/NCT01666847</url>
  </required_header>
  <id_info>
    <org_study_id>21429</org_study_id>
    <nct_id>NCT01666847</nct_id>
  </id_info>
  <brief_title>Milking the Umbilical Cord for Extreme Preterm Infants</brief_title>
  <official_title>Milking the Umbilical Cord for Extreme Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Milking the umbilical cord from the placental end toward the infant has been shown to benefit&#xD;
      preterm infants when compared to either clamping the umbilical cord immediately or waiting&#xD;
      delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown&#xD;
      to improve heart and lung function, reduces the need for blood transfusion, and reduces the&#xD;
      risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical&#xD;
      cord, however in extremely premature infants is not considered safe, since it also delays the&#xD;
      resuscitation that these infants need immediately after birth. Milking the umbilical cord is&#xD;
      believed have similar benefits to delaying the clamping of the cord, but can be done much&#xD;
      faster (seconds rather than minutes). In this study, the cord will milked three times over&#xD;
      about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for&#xD;
      routine care. Participants of this study will be randomly assigned to one of two study&#xD;
      groups: the first group will have the cord milking intervention and the second group will not&#xD;
      have any intervention other than routine, immediate cord clamping with routine care of mother&#xD;
      and infant. Data will be collected about the mother prior to delivery and data will also be&#xD;
      collected about the baby using computerized health records. The data will look at short term&#xD;
      changes in red blood cell volumes, the need for blood transfusions, and rates of known&#xD;
      complications of prematurity, including longer term developmental complications at 18-24&#xD;
      months.&#xD;
&#xD;
      The hypothesis is that milking the umbilical cord before cutting the cord will lead to a&#xD;
      higher hemoglobin concentration and decrease the need for blood transfusions in extremely&#xD;
      preterm neonates compared to the current standard of immediately clamping the umbilical cord.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do&#xD;
      not have congenital anomalies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">August 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping</measure>
    <time_frame>Within 4 hour of birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>To evaluate and compare the incidence and numbers of blood transfusions after cord milking</measure>
    <time_frame>Prior to initial infant discharge</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To evaluate and compare blood pressure after intervention and need for support medications</measure>
    <time_frame>For first seven days of life</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy</measure>
    <time_frame>Three weeks</time_frame>
    <description>Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate the incidence of complications of prematurity in the study and control groups</measure>
    <time_frame>Until 3 years corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To evaluate long term outcomes of prematurity in both groups in a follow-up study</measure>
    <time_frame>Until 3 years corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare the difference in hemoglobin and hematocrit from umbilical cord blood</measure>
    <time_frame>Within 4 hours of birth</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">59</enrollment>
  <condition>Infant, Extremely Premature</condition>
  <arm_group>
    <arm_group_label>Cord Milking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infant receiving cord milking intervention before umbilical cord clamped.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Immediate Cord Clamping</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Infant whose umbilical cord is immediately clamped after delivery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Milking the umbilical cord before cord clamping</intervention_name>
    <description>The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.</description>
    <arm_group_label>Cord Milking</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women/child pairs with infants born at an estimated gestation age between 24&#xD;
             0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or&#xD;
             ultrasound&#xD;
&#xD;
          -  informed consent obtained by the pregnant women prior to delivery of the infant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy with a multiple gestation&#xD;
&#xD;
          -  infants with pre- or postnatally diagnosed major congenital anomalies or probable&#xD;
             chromosomal abnormalities&#xD;
&#xD;
          -  infants with hydrops fetalis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Justin B Josephsen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University, Division of Neonatology, SSM Cardinal Glennon Children's Medical Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Louis University, Division of Neonatology, SSM St. Mary's Health Center</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63117</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. doi: 10.1136/adc.2006.108902. Epub 2007 Jan 18.</citation>
    <PMID>17234653</PMID>
  </reference>
  <reference>
    <citation>Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. doi: 10.1097/01.AOG.0000277262.80793.0d.</citation>
    <PMID>17766607</PMID>
  </reference>
  <reference>
    <citation>Rabe H, Jewison A, Fernandez Alvarez R, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-211. doi: 10.1097/AOG.0b013e3181fe46ff.</citation>
    <PMID>21252731</PMID>
  </reference>
  <reference>
    <citation>Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.</citation>
    <PMID>15495045</PMID>
  </reference>
  <reference>
    <citation>Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.</citation>
    <PMID>17890882</PMID>
  </reference>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 11, 2019</last_update_submitted>
  <last_update_submitted_qc>August 11, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Justin Josephsen M.D.</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Umbilical Cord Milking</keyword>
  <keyword>Extremely Low Birth Weight Infant (ELBW)</keyword>
  <!-- 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/NCT01666847
org study id: 21429
nct id: NCT01666847
lead sponsor: 
has dmc: Yes
Milking the umbilical cord from the placental end toward the infant has been shown to benefit
      preterm infants when compared to either clamping the umbilical cord immediately or waiting
      delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown
      to improve heart and lung function, reduces the need for blood transfusion, and reduces the
      risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical
      cord, however in extremely premature infants is not considered safe, since it also delays the
      resuscitation that these infants need immediately after birth. Milking the umbilical cord is
      believed have similar benefits to delaying the clamping of the cord, but can be done much
      faster (seconds rather than minutes). In this study, the cord will milked three times over
      about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for
      routine care. Participants of this study will be randomly assigned to one of two study
      groups: the first group will have the cord milking intervention and the second group will not
      have any intervention other than routine, immediate cord clamping with routine care of mother
      and infant. Data will be collected about the mother prior to delivery and data will also be
      collected about the baby using computerized health records. The data will look at short term
      changes in red blood cell volumes, the need for blood transfusions, and rates of known
      complications of prematurity, including longer term developmental complications at 18-24
      months.

      The hypothesis is that milking the umbilical cord before cutting the cord will lead to a
      higher hemoglobin concentration and decrease the need for blood transfusions in extremely
      preterm neonates compared to the current standard of immediately clamping the umbilical cord.
Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do
      not have congenital anomalies.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping
time frame: Within 4 hour of birth
measure: To evaluate and compare the incidence and numbers of blood transfusions after cord milking
time frame: Prior to initial infant discharge
measure: To evaluate and compare blood pressure after intervention and need for support medications
time frame: For first seven days of life
measure: To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy
time frame: Three weeks
description: Highest bilirubin or maximum at 120 hours of life, plus total days of phototherapy.
measure: To evaluate the incidence of complications of prematurity in the study and control groups
time frame: Until 3 years corrected gestational age
measure: To evaluate long term outcomes of prematurity in both groups in a follow-up study
time frame: Until 3 years corrected gestational age
measure: To compare the difference in hemoglobin and hematocrit from umbilical cord blood
time frame: Within 4 hours of birth
arm group label: Cord Milking
arm group type: Experimental
description: Infant receiving cord milking intervention before umbilical cord clamped.
arm group label: Immediate Cord Clamping
arm group type: No Intervention
description: Infant whose umbilical cord is immediately clamped after delivery.
intervention type: Procedure
intervention name: Milking the umbilical cord before cord clamping
description: The procedure will involve positioning the neonate below the level of the placenta and milking approximately 20cm of umbilical cord three times over 10-20 seconds total from the placental end to the neonate. The cord will then be clamped and the neonate handed to the awaiting medical team for routine care of a premature infant.
arm group label: Cord Milking
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Justin B Josephsen, MD
role: Principal Investigator
affiliation: St. Louis University
facility: 
facility: 
country: United States
citation: Hosono S, Mugishima H, Fujita H, Hosono A, Minato M, Okada T, Takahashi S, Harada K. Umbilical cord milking reduces the need for red cell transfusions and improves neonatal adaptation in infants born at less than 29 weeks' gestation: a randomised controlled trial. Arch Dis Child Fetal Neonatal Ed. 2008 Jan;93(1):F14-9. doi: 10.1136/adc.2006.108902. Epub 2007 Jan 18.
PMID: 17234653
citation: Leavitt BG, Huff DL, Bell LA, Thurnau GR. Placental drainage of fetal blood at cesarean delivery and feto maternal transfusion: a randomized controlled trial. Obstet Gynecol. 2007 Sep;110(3):608-11. doi: 10.1097/01.AOG.0000277262.80793.0d.
PMID: 17766607
citation: Rabe H, Jewison A, Fernandez Alvarez R, Crook D, Stilton D, Bradley R, Holden D; Brighton Perinatal Study Group. Milking compared with delayed cord clamping to increase placental transfusion in preterm neonates: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):205-211. doi: 10.1097/AOG.0b013e3181fe46ff.
PMID: 21252731
citation: Rabe H, Reynolds G, Diaz-Rossello J. Early versus delayed umbilical cord clamping in preterm infants. Cochrane Database Syst Rev. 2004 Oct 18;(4):CD003248. doi: 10.1002/14651858.CD003248.pub2.
PMID: 15495045
citation: Rabe H, Reynolds G, Diaz-Rossello J. A systematic review and meta-analysis of a brief delay in clamping the umbilical cord of preterm infants. Neonatology. 2008;93(2):138-44. doi: 10.1159/000108764. Epub 2007 Sep 21.
PMID: 17890882
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Justin Josephsen M.D.
investigator title: Assistant Professor