<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/NCT03023917</url>
  </required_header>
  <id_info>
    <org_study_id>XH-16-050</org_study_id>
    <nct_id>NCT03023917</nct_id>
  </id_info>
  <brief_title>The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in Preterms</brief_title>
  <official_title>The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Shanghai First Maternity and Infant Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yangpu District Central Hospital Affiliated to Tongji University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</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 overall objective of the present study is to examine the effects of umbilical cord&#xD;
      milking at birth in preterm infants to prevent and decrease anemia using a multi-center&#xD;
      prospective randomized controlled trial comparing immediate cord clamping (standard at&#xD;
      present) with umbilical cord milking.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anemia is a significant problem for pre-term infants and a major risk factor for preterm&#xD;
      babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of&#xD;
      pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion&#xD;
      is a safe procedure but like all therapeutic interventions has risks associated with it and&#xD;
      effort is made to reduce the number of transfusions that infants require during their stay on&#xD;
      the neonatal unit.&#xD;
&#xD;
      Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy&#xD;
      because of increased iron stores at birth. However there are controversies in incorporating&#xD;
      delayed cord clamping practice in the management of third stage of labour globally.&#xD;
      Concerning about the need for urgent resuscitation and temperature management, attendants&#xD;
      encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care&#xD;
      can start as soon as possible.However,umbilical cord milking allows for swift intervention&#xD;
      and resuscitation and attention to thermal care and should take less than 10 seconds to&#xD;
      complete.&#xD;
&#xD;
      The specific aim of this study is to investigate the effects of umbilical cord milking on&#xD;
      preventing and decreasing anemia in very pre-term infants.&#xD;
&#xD;
      Primary Outcomes:&#xD;
&#xD;
      Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of&#xD;
      age.&#xD;
&#xD;
      Secondary Outcomes:&#xD;
&#xD;
        -  Hemoglobin,hematocrit levels at 6 months of age.&#xD;
&#xD;
        -  Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the&#xD;
           respective cutoffs.&#xD;
&#xD;
        -  number of blood transfusions until 3 months corrected gestational age (CGA).&#xD;
&#xD;
        -  short term clinical profile of neonates like jaundice, polycythemia etc.&#xD;
&#xD;
        -  preterm infant complications such as lung function as assessed by oxygen dependency at&#xD;
           36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the&#xD;
           need for volume expansion, inotropes, or clinically suspected patent ductus&#xD;
           arteriosus(PDA )requiring intervention prior to discharge home,incidence of&#xD;
           intraventricular hemorrhage and late-onset sepsis,etc.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 30, 2017</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">August 31, 2019</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>concentrations of Hemoglobin (Hb)</measure>
    <time_frame>48 hours after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>concentrations of Hematocrit(Hct)</measure>
    <time_frame>48 hours after birth</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>serum ferritin level</measure>
    <time_frame>48 hours after birth</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hyperbilirubinemia requiring phototherapy</measure>
    <time_frame>during first 2 weeks of age</time_frame>
    <description>Hyperbilirubinemia requiring phototherapy (as per routine unit practice)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence and numbers of blood transfusions</measure>
    <time_frame>until 3 months corrected gestational age</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of admission</measure>
    <time_frame>Birth to discharge, expected average of 30 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication</measure>
    <time_frame>Birth to discharge, expected average of 30 days</time_frame>
    <description>composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">284</enrollment>
  <condition>Anemia</condition>
  <arm_group>
    <arm_group_label>umbilical cord clamping immediately</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the &quot;control&quot; group).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>umbilical cord milking</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>umbilical cord milking</intervention_name>
    <description>Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds</description>
    <arm_group_label>umbilical cord milking</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>umbilical cord clamping immediately</intervention_name>
    <description>umbilical cord was cut immediately after birth</description>
    <arm_group_label>umbilical cord clamping immediately</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in labour or with a plan for delivery at a gestational age less than 34 weeks&#xD;
             gestation.&#xD;
&#xD;
          -  Singleton pregnancy&#xD;
&#xD;
          -  informed consent was obtained from the parent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Multiple gestation&#xD;
&#xD;
          -  Diagnosis of any of the following in the current pregnancy: hemorrhage requiring&#xD;
             clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome&#xD;
             of the fetus,anemia&#xD;
&#xD;
          -  Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies&#xD;
&#xD;
          -  Diagnosis at any time for the mother of any of the following: serious Diabetes,&#xD;
             serious hypertension, chronic renal disease&#xD;
&#xD;
          -  Infant with major congenital malformation&#xD;
&#xD;
          -  Infant with blood disease&#xD;
&#xD;
          -  Unwilling to return for follow-up study visits at the hospital&#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>guangyu chen</last_name>
    <role>Study Chair</role>
    <affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Xinhua Hospital</name>
      <address>
        <city>Shanghai</city>
        <state>Shanghai</state>
        <zip>200092</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 13, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 18, 2017</study_first_posted>
  <last_update_submitted>October 24, 2020</last_update_submitted>
  <last_update_submitted_qc>October 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Xinhua Hospital, Shanghai Jiao Tong University School of Medicine</investigator_affiliation>
    <investigator_full_name>Lijuan Xie</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>umbilical cord milking;anemia;placental transfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anemia</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/NCT03023917
org study id: XH-16-050
nct id: NCT03023917
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The overall objective of the present study is to examine the effects of umbilical cord
      milking at birth in preterm infants to prevent and decrease anemia using a multi-center
      prospective randomized controlled trial comparing immediate cord clamping (standard at
      present) with umbilical cord milking.
Anemia is a significant problem for pre-term infants and a major risk factor for preterm
      babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of
      pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion
      is a safe procedure but like all therapeutic interventions has risks associated with it and
      effort is made to reduce the number of transfusions that infants require during their stay on
      the neonatal unit.

      Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy
      because of increased iron stores at birth. However there are controversies in incorporating
      delayed cord clamping practice in the management of third stage of labour globally.
      Concerning about the need for urgent resuscitation and temperature management, attendants
      encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care
      can start as soon as possible.However,umbilical cord milking allows for swift intervention
      and resuscitation and attention to thermal care and should take less than 10 seconds to
      complete.

      The specific aim of this study is to investigate the effects of umbilical cord milking on
      preventing and decreasing anemia in very pre-term infants.

      Primary Outcomes:

      Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of
      age.

      Secondary Outcomes:

        -  Hemoglobin,hematocrit levels at 6 months of age.

        -  Anemia at 1 week of life and 6 months follow-up, defined as hemoglobin levels below the
           respective cutoffs.

        -  number of blood transfusions until 3 months corrected gestational age (CGA).

        -  short term clinical profile of neonates like jaundice, polycythemia etc.

        -  preterm infant complications such as lung function as assessed by oxygen dependency at
           36 weeks corrected gestational age (CGA), and cardiovascular function as assessed by the
           need for volume expansion, inotropes, or clinically suspected patent ductus
           arteriosus(PDA )requiring intervention prior to discharge home,incidence of
           intraventricular hemorrhage and late-onset sepsis,etc.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
measure: concentrations of Hemoglobin (Hb)
time frame: 48 hours after birth
measure: concentrations of Hematocrit(Hct)
time frame: 48 hours after birth
measure: serum ferritin level
time frame: 48 hours after birth
measure: Hyperbilirubinemia requiring phototherapy
time frame: during first 2 weeks of age
description: Hyperbilirubinemia requiring phototherapy (as per routine unit practice)
measure: incidence and numbers of blood transfusions
time frame: until 3 months corrected gestational age
measure: Length of admission
time frame: Birth to discharge, expected average of 30 days
measure: complication
time frame: Birth to discharge, expected average of 30 days
description: composite of bronchopulmonary dysplasia , Necrotizing Enterocolitis , grade 3 or 4 intraventricular hemorrhage or periventricular leukomalacia , or death prior to discharge home
arm group label: umbilical cord clamping immediately
arm group type: Active Comparator
description: Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).
arm group label: umbilical cord milking
arm group type: Experimental
description: preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
intervention type: Procedure
intervention name: umbilical cord milking
description: Infants were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
arm group label: umbilical cord milking
intervention type: Procedure
intervention name: umbilical cord clamping immediately
description: umbilical cord was cut immediately after birth
arm group label: umbilical cord clamping immediately
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: guangyu chen
role: Study Chair
affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
investigator full name: Lijuan Xie
investigator title: Principal Investigator
mesh term: Anemia
sharing ipd: No