<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/NCT02216292</url>
  </required_header>
  <id_info>
    <org_study_id>PSDM001</org_study_id>
    <nct_id>NCT02216292</nct_id>
  </id_info>
  <brief_title>Impact of Preterm Single Donor Milk in Very Low Birth Weight Infants</brief_title>
  <official_title>Impact of Preterm Single Donor Milk on Enteral Feeding in Very Low Birth Weight Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Human milk is the best source of enteral nutrition for the preterm infant. However during the&#xD;
      infants first hours and days of life breastmilk from the own mother is usually not available.&#xD;
      Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical&#xD;
      University Vienna was to start with formula feedings within the first 6 hours of life of a&#xD;
      premature infant and switch over to breastmilk as soon it was available. In June 2012 the&#xD;
      investigators changed this feeding regimen and started to use single donor milk of mothers of&#xD;
      preterm infants for the first hours and days of the preterm infants life. In a prospective&#xD;
      observational study the investigators evaluated the impact of single donor milk from preterm&#xD;
      infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in&#xD;
      preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data&#xD;
      will be compared with a historical control group starting with preterm formula as source of&#xD;
      enteral nutrition. The investigators hypothesize that starting enteral nutrition with single&#xD;
      donor milk of mothers from preterm infants with shorten time to full enteral feedings.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2014</completion_date>
  <primary_completion_date type="Actual">April 2013</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time to full enteral feeding</measure>
    <time_frame>birth up to 40 weeks of gestation</time_frame>
    <description>Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>necrotizing enterocolitis</measure>
    <time_frame>birth to 40 weeks of gestation</time_frame>
    <description>Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gastric residuals</measure>
    <time_frame>birth to 7th day of life</time_frame>
    <description>Gastric residuals are a parameter for gastrointestinal tolerance and are determined every three hours before the next meal is given and are aspirated via a gastric tube Gastric residuals are measured in ml/kg per meal. Furthermore the color is documented (milky, clear, mucous, bile stained, bloody)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of stool</measure>
    <time_frame>birth until 14th day of life</time_frame>
    <description>Number of stools per day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>culture positive sepsis</measure>
    <time_frame>birth to 40th week of gestation</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>body weight</measure>
    <time_frame>birth to 40th week of gestation</time_frame>
    <description>body weight in gram is measured every second day.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Infant, Premature, Diseases</condition>
  <arm_group>
    <arm_group_label>Preterm Single Donor Milk Group</arm_group_label>
    <description>The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <description>Retrospective control group receiving no donor milk = control group from March 2011 - May 2012</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control Group</intervention_name>
    <description>Infants received preterm formula during their first days of life until breastmilk from their own mother was available</description>
    <arm_group_label>Control Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Preterm Single Donor Milk Group</intervention_name>
    <description>Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available</description>
    <arm_group_label>Preterm Single Donor Milk Group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        inborn very low birth weight infants with a birthweight &lt;1500g and a gestational age &lt;32&#xD;
        weeks&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  very low birth weight infants with a birthweight &lt;1500g&#xD;
&#xD;
          -  Gestational Age &lt;32 weeks&#xD;
&#xD;
          -  Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital malformations&#xD;
&#xD;
          -  systemic metabolic diseases&#xD;
&#xD;
          -  short bowl syndrome&#xD;
&#xD;
          -  gastrointestinal abnormalities&#xD;
&#xD;
          -  when preterm infant was transferred or discharged&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>1 Year</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nadja Haiden, Prof.MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Vienna, Department of Pediatrics</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Vienna</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 11, 2014</last_update_submitted>
  <last_update_submitted_qc>August 11, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Nadja Haiden,MD</investigator_full_name>
    <investigator_title>MD, Assoc. Prof.</investigator_title>
  </responsible_party>
  <keyword>preterm single donor milk</keyword>
  <keyword>human milk</keyword>
  <keyword>very lo birth weight infants</keyword>
  <keyword>enteral feedings</keyword>
  <keyword>NEC</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infant, Premature, Diseases</mesh_term>
    <mesh_term>Birth Weight</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/NCT02216292
org study id: PSDM001
nct id: NCT02216292
lead sponsor: 
has dmc: Yes
Human milk is the best source of enteral nutrition for the preterm infant. However during the
      infants first hours and days of life breastmilk from the own mother is usually not available.
      Until May 2012 the practice in the Neonatal Division of the Department of Pediatrics /Medical
      University Vienna was to start with formula feedings within the first 6 hours of life of a
      premature infant and switch over to breastmilk as soon it was available. In June 2012 the
      investigators changed this feeding regimen and started to use single donor milk of mothers of
      preterm infants for the first hours and days of the preterm infants life. In a prospective
      observational study the investigators evaluated the impact of single donor milk from preterm
      infants on time to full enteral feedings, gastrointestinal tolerance and NEC incidence in
      preterm infants with a birthweight below 1500 grams and a gestational below 32 weeks. Data
      will be compared with a historical control group starting with preterm formula as source of
      enteral nutrition. The investigators hypothesize that starting enteral nutrition with single
      donor milk of mothers from preterm infants with shorten time to full enteral feedings.
observational model: Cohort
time perspective: Prospective
measure: Time to full enteral feeding
time frame: birth up to 40 weeks of gestation
description: Full enteral feedings are defined as an enteral inane of 135-145ml/kg/d
measure: necrotizing enterocolitis
time frame: birth to 40 weeks of gestation
description: Necrotising enterocolitis (NEC) was defined according to the stages by Bell as proven NEC grade 2a.
measure: Gastric residuals
time frame: birth to 7th day of life
description: Gastric residuals are a parameter for gastrointestinal tolerance and are determined every three hours before the next meal is given and are aspirated via a gastric tube Gastric residuals are measured in ml/kg per meal. Furthermore the color is documented (milky, clear, mucous, bile stained, bloody)
measure: Frequency of stool
time frame: birth until 14th day of life
description: Number of stools per day
measure: culture positive sepsis
time frame: birth to 40th week of gestation
measure: body weight
time frame: birth to 40th week of gestation
description: body weight in gram is measured every second day.
arm group label: Preterm Single Donor Milk Group
description: The prospective study group = preterm single donor milk group (PSDM-Group) from June 2012 - April 2013
arm group label: Control Group
description: Retrospective control group receiving no donor milk = control group from March 2011 - May 2012
intervention type: Other
intervention name: Control Group
description: Infants received preterm formula during their first days of life until breastmilk from their own mother was available
arm group label: Control Group
intervention type: Other
intervention name: Preterm Single Donor Milk Group
description: Infants received preterm single donor milk during their first days of life until breastmilk from their own mother was available
arm group label: Preterm Single Donor Milk Group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 1 Year
healthy volunteers: No
last name: Nadja Haiden, Prof.MD
role: Principal Investigator
affiliation: Medical University of Vienna, Department of Pediatrics
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Nadja Haiden,MD
investigator title: MD, Assoc. Prof.
mesh term: Infant, Premature, Diseases
mesh term: Birth Weight