<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/NCT01670916</url>
  </required_header>
  <id_info>
    <org_study_id>RHNEO-NEC01</org_study_id>
    <nct_id>NCT01670916</nct_id>
  </id_info>
  <brief_title>Probiotics to Prevent NEC - a Historical Control Study</brief_title>
  <official_title>Probiotics to Prevent NEC Stage II+ in Very Preterm Infants - a Historical Control Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</source>
  <brief_summary>
    <textblock>
      Probiotics is given routinely to infants admitted to the department of neonatology during the&#xD;
      first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence&#xD;
      of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical&#xD;
      records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1&#xD;
      March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009&#xD;
      will be compared.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2010</start_date>
  <completion_date type="Actual">June 2013</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>Case-Control</observational_model>
  </study_design_info>
  <primary_outcome>
    <measure>NEC</measure>
    <time_frame>From birth until discharge home</time_frame>
    <description>The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER.&#xD;
NEC-II/III is the primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death with NEC</measure>
    <time_frame>Birth to discharge home</time_frame>
    <description>Death with a review board classification of NEC-II/III</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Birth to discharge home</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Positive culture of probiotic bacteria</measure>
    <time_frame>Birth to discharge from Rigshospitalet</time_frame>
    <description>Growth of lactobacilli or bifidobacteria from a normally sterile fluid</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">714</enrollment>
  <condition>Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>Probiotics</arm_group_label>
    <description>Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <description>Probiotics never given</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>probiotics</intervention_name>
    <description>Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.</description>
    <arm_group_label>Probiotics</arm_group_label>
    <other_name>Bifiform, Ferrosan A/S</other_name>
    <other_name>Idoform, Ferronan A/S</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Newborn infants admitted for special or intensive care&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age less than 30 weeks&#xD;
&#xD;
          -  Admission during the first 3 days of life&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>3 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Neonatology, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>September 2013</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>September 30, 2013</last_update_submitted>
  <last_update_submitted_qc>September 30, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Gorm Greisen</investigator_full_name>
    <investigator_title>professor, consultant neonatologist</investigator_title>
  </responsible_party>
  <keyword>Necrotizing enterocolitis</keyword>
  <keyword>Probiotics</keyword>
  <keyword>Preterm</keyword>
  <keyword>Infant</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Enterocolitis</mesh_term>
    <mesh_term>Enterocolitis, Necrotizing</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/NCT01670916
org study id: RHNEO-NEC01
nct id: NCT01670916
lead sponsor: 
Probiotics is given routinely to infants admitted to the department of neonatology during the
      first 3 days of life with gestational age less than 30 weeks since March 2010. The incidence
      of necrotizing enterocolitis Bell stage II and III will be assessed blindly from clinical
      records. It is hypothesised that the incidence of NEC will decrease. Infants admitted from 1
      March 2010 to 28 February 2013 will be compared to infants admitted 1 Dec 2007 to 30 Nov 2009
      will be compared.
observational model: Case-Control
measure: NEC
time frame: From birth until discharge home
description: The clinical records of infants who had a discharge diagnosis of necrotizing enterocolitis are selected. Records of infants who had a prescription of metronidazole for a non-preventive purpose is added. The clinical records are abstracted. The abstracts and X-rays are presented to a review board that are blinded to the period of birth. The board classifies the cases as NEC-I, NEC-II, NEC-III, focal intestinal perforation, and OTHER.
NEC-II/III is the primary outcome.
measure: Death with NEC
time frame: Birth to discharge home
description: Death with a review board classification of NEC-II/III
measure: Death
time frame: Birth to discharge home
measure: Positive culture of probiotic bacteria
time frame: Birth to discharge from Rigshospitalet
description: Growth of lactobacilli or bifidobacteria from a normally sterile fluid
arm group label: Probiotics
description: Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
arm group label: Control
description: Probiotics never given
intervention type: Dietary Supplement
intervention name: probiotics
description: Capsule with 1 x 10**9 Lactobacillus rhamnosus GG and 1 x 10**8 Bifidobacterium BB12. Two capsules once a day. The capsules are opened and the content is dissolved in mother's milk or water if the baby is given any milk. In tube fed infants, two drops are given in the mouth and the rest in the nasogastric tube.
arm group label: Probiotics
other name: Bifiform, Ferrosan A/S
other name: Idoform, Ferronan A/S
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 3 Days
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Gorm Greisen
investigator title: professor, consultant neonatologist
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing