<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/NCT02998489</url>
  </required_header>
  <id_info>
    <org_study_id>2014/25</org_study_id>
    <nct_id>NCT02998489</nct_id>
  </id_info>
  <brief_title>Effectiveness and Safety of Fast Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight</brief_title>
  <official_title>Effectiveness and Safety of Rapid Enteral Feeding in Preterm Infants Between 1000 and 2000 Grams of Birth Weight</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitario San Ignacio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitario San Ignacio</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized controlled trial with infants less than 34 weeks and between 1000 and&#xD;
      2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral&#xD;
      advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Progression of enteral feeding in preterm infants is still controversial. The neonatologist&#xD;
      needs to provide adequate caloric intake avoiding the risk of food intolerance and&#xD;
      necrotizing enterocolitis.&#xD;
&#xD;
      Objective: To establish the safety and effectiveness of fast enteral advancement compared&#xD;
      with traditional advancement.&#xD;
&#xD;
      Design: A randomized controlled clinical trial with infants less than 34 weeks and between&#xD;
      1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá,&#xD;
      Colombia.&#xD;
&#xD;
      Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc&#xD;
      versus 20 cc / kg / day advancing in infants between 1500 and 1999g.&#xD;
&#xD;
      Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or&#xD;
      intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance,&#xD;
      anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis,&#xD;
      hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be&#xD;
      analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test.&#xD;
      Multiple linear regression will be performed.&#xD;
&#xD;
      Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia&#xD;
      Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to&#xD;
      parents.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2014</start_date>
  <completion_date type="Actual">September 12, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2015</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>days to reach full enteral nutrition</measure>
    <time_frame>number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>days of intravenous fluids</measure>
    <time_frame>number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>days to regain birth weight</measure>
    <time_frame>number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of days employed to regain birth weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>episodes of food intolerance</measure>
    <time_frame>number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of episodes of food intolerance per day during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight at 40 weeks</measure>
    <time_frame>weight at 40 weeks of post menstrual age</time_frame>
    <description>weight in grams at 40 weeks of post menstrual age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>length at 40 weeks</measure>
    <time_frame>length at 40 weeks of post menstrual age</time_frame>
    <description>length in centimeters at 40 weeks of post menstrual age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>head circumference at 40 weeks</measure>
    <time_frame>head circumference at 40 weeks of post menstrual age</time_frame>
    <description>head circumference in centimeters at 40 weeks of post menstrual age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>weight gain per day at 40 weeks of post menstrual age</measure>
    <time_frame>weight gain in grams per day from birth until 40 weeks of post menstrual age</time_frame>
    <description>weight gain in gr./d from birth until 40 weeks of post menstrual age</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of necrotizing enterocolitis</measure>
    <time_frame>through study completion(from date of randomization until 40 weeks of post menstrual age)</time_frame>
    <description>rate of necrotizing enterocolitis through study completion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of mortality</measure>
    <time_frame>through study completion(from date of randomization until 40 weeks of post menstrual age)</time_frame>
    <description>number of patients who died during the study's follow up</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of late onset sepsis</measure>
    <time_frame>from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of patients who had late onset sepsis during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hyperbilirubinemia</measure>
    <time_frame>from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>rate of hypoglycemia</measure>
    <time_frame>from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks</time_frame>
    <description>number of patients who had hypoglycemia during hospitalization</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Feeding Behavior</condition>
  <arm_group>
    <arm_group_label>Fast milk advancement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional milk advancement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Fast milk advancement</intervention_name>
    <description>30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved</description>
    <arm_group_label>Fast milk advancement</arm_group_label>
    <other_name>Milk</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional milk advancement</intervention_name>
    <description>20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved</description>
    <arm_group_label>Traditional milk advancement</arm_group_label>
    <other_name>Milk</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants less than 34 weeks of gestational age.&#xD;
&#xD;
          -  Weight at birth between 1000 and 2000 grams.&#xD;
&#xD;
          -  Infants hospitalized in the newborn unit at Hospital Universitario San Ignacio in&#xD;
             Bogotá, Colombia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Perinatal Asphyxia&#xD;
&#xD;
          -  Intrauterine Growth Restriction&#xD;
&#xD;
          -  Diagnosis of Congenital Hearth Disease&#xD;
&#xD;
          -  Severe Hypoxemia&#xD;
&#xD;
          -  Major Congenital Malformations&#xD;
&#xD;
          -  Metabolic Disease&#xD;
&#xD;
          -  Intolerance to initiate oral feeding at the eligibility&#xD;
&#xD;
          -  Patent Ductus with hemodynamic instability&#xD;
&#xD;
          -  Early Onset Sepsis with hemodynamic instability&#xD;
&#xD;
          -  Refusal of parents to participate in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>72 Hours</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Adriana Montealegre, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Universitario San Ignacio</affiliation>
  </overall_official>
  <results_reference>
    <citation>Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD001241. doi: 10.1002/14651858.CD001241.pub6.</citation>
    <PMID>26469124</PMID>
  </results_reference>
  <results_reference>
    <citation>Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.</citation>
    <PMID>21730906</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>March 22, 2018</last_update_submitted>
  <last_update_submitted_qc>March 22, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 23, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>enteral nutrition</keyword>
  <keyword>infant,premature</keyword>
  <keyword>feeding method</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Birth Weight</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/NCT02998489
org study id: 2014/25
nct id: NCT02998489
lead sponsor: 
has dmc: Yes
This is a randomized controlled trial with infants less than 34 weeks and between 1000 and
      2000 grams at birth, that seeks to establish the safety and effectiveness of fast enteral
      advancement (milk 30-40 cc/kg/d) compared with traditional advancement (milk 20 cc/kg/d)
Progression of enteral feeding in preterm infants is still controversial. The neonatologist
      needs to provide adequate caloric intake avoiding the risk of food intolerance and
      necrotizing enterocolitis.

      Objective: To establish the safety and effectiveness of fast enteral advancement compared
      with traditional advancement.

      Design: A randomized controlled clinical trial with infants less than 34 weeks and between
      1000 and 2000 grams at birth conducted at Hospital Universitario San Ignacio in Bogotá,
      Colombia.

      Methods: 30 cc versus 20 cc / kg / day advancing in infants between 1000 and 1499g and 40cc
      versus 20 cc / kg / day advancing in infants between 1500 and 1999g.

      Outcomes: days to reach full enteral nutrition, days of parenteral nutrition (PN) and/or
      intravenous fluids (IVF), days to regain birth weight, episodes of food intolerance,
      anthropometric measurements and weight gain at 40 weeks; rate of late onset sepsis,
      hypoglycemia, hyperbilirubinemia, necrotizing enterocolitis (NEC) and mortality. Data will be
      analyzed with Student t test or Mann-Whitney U-test and Pearson Chi-square or Fisher test.
      Multiple linear regression will be performed.

      Ethics: This Protocol was approved by the Ethics and Research Committee of Pontificia
      Universidad Javeriana and San Ignacio Hospital. Informed consent will be requested to
      parents.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: days to reach full enteral nutrition
time frame: number of days from date of randomization until the day that the baby reach full enteral nutrition or date of death from any cause assessed up to 12 weeks
description: number of days employed to reach full enteral nutrition with breast milk, formula milk or breast milk plus formula milk.
measure: days of intravenous fluids
time frame: number of days of intravenous fluids from birth until suspension of them or date of death from any cause assessed up to 12 weeks
description: number of days with intravenous fluids included parenteral nutrition and dextrose with electrolytes
measure: days to regain birth weight
time frame: number of days from birth, employed to regain birth weight or date of death from any cause assessed up to 12 weeks
description: number of days employed to regain birth weight
measure: episodes of food intolerance
time frame: number of episodes of food intolerance per day from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
description: number of episodes of food intolerance per day during hospitalization
measure: weight at 40 weeks
time frame: weight at 40 weeks of post menstrual age
description: weight in grams at 40 weeks of post menstrual age
measure: length at 40 weeks
time frame: length at 40 weeks of post menstrual age
description: length in centimeters at 40 weeks of post menstrual age
measure: head circumference at 40 weeks
time frame: head circumference at 40 weeks of post menstrual age
description: head circumference in centimeters at 40 weeks of post menstrual age
measure: weight gain per day at 40 weeks of post menstrual age
time frame: weight gain in grams per day from birth until 40 weeks of post menstrual age
description: weight gain in gr./d from birth until 40 weeks of post menstrual age
measure: rate of necrotizing enterocolitis
time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
description: rate of necrotizing enterocolitis through study completion
measure: rate of mortality
time frame: through study completion(from date of randomization until 40 weeks of post menstrual age)
description: number of patients who died during the study's follow up
measure: rate of late onset sepsis
time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
description: number of patients who had late onset sepsis during hospitalization
measure: rate of hyperbilirubinemia
time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
description: number of patients who had hyperbilirubinemia and were treated with phototherapy during hospitalization
measure: rate of hypoglycemia
time frame: from date of randomization until hospital discharge or date of death from any cause assessed up to 12 weeks
description: number of patients who had hypoglycemia during hospitalization
arm group label: Fast milk advancement
arm group type: Experimental
description: 30-40 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction
arm group label: Traditional milk advancement
arm group type: Active Comparator
description: 20 cc/kg/d of human milk or formula milk administered by orogastric tube or by suction
intervention type: Other
intervention name: Fast milk advancement
description: 30-40 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
arm group label: Fast milk advancement
other name: Milk
intervention type: Other
intervention name: Traditional milk advancement
description: 20 cc/kg/d of human milk or formula milk until total enteral feeding has been achieved
arm group label: Traditional milk advancement
other name: Milk
criteria: 
gender: All
minimum age: N/A
maximum age: 72 Hours
healthy volunteers: No
last name: Adriana Montealegre, Dr.
role: Principal Investigator
affiliation: Hospital Universitario San Ignacio
citation: Morgan J, Young L, McGuire W. Slow advancement of enteral feed volumes to prevent necrotising enterocolitis in very low birth weight infants. Cochrane Database Syst Rev. 2015 Oct 15;(10):CD001241. doi: 10.1002/14651858.CD001241.pub6.
PMID: 26469124
citation: Moore TA, Wilson ME. Feeding intolerance: a concept analysis. Adv Neonatal Care. 2011 Jun;11(3):149-54. doi: 10.1097/ANC.0b013e31821ba28e.
PMID: 21730906
responsible party type: Sponsor
mesh term: Birth Weight
sharing ipd: No