<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/NCT03302338</url>
  </required_header>
  <id_info>
    <org_study_id>SAFE 2013</org_study_id>
    <nct_id>NCT03302338</nct_id>
  </id_info>
  <brief_title>Simulated Amniotic Fluid Solution in Neonates Recovering From GIT Surgeries</brief_title>
  <official_title>Simulated Amniotic Fluid Like Solution Enterally Administrated in Neonates Recovering From GIT Surgeries</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rania Ali El-Farrash</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Amniotic fluid plays a significant role in fetal gut maturation and development. The human&#xD;
      fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such&#xD;
      swallowing is essential for normal small bowel development.Growth factors found in the&#xD;
      amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding&#xD;
      intolerance is a common problem among neonates recovering from surgery for congenital bowel&#xD;
      abnormalities, the investigators will study the role of enteral administration of simulated&#xD;
      amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering&#xD;
      from GIT surgeries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neonates with congenital GIT anomalies will participate after being operated.&#xD;
&#xD;
      Participants will be followed for the duration of hospital stay until discharge or death.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2015</start_date>
  <completion_date type="Anticipated">October 2018</completion_date>
  <primary_completion_date type="Anticipated">June 2018</primary_completion_date>
  <phase>Phase 1</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Signs of feeding intolerance</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Necrotizing enterocolitis</measure>
    <time_frame>The outcome measure will be assessed within 2 months</time_frame>
    <description>• Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hospital stay</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
    <description>duration on hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mortality</measure>
    <time_frame>he outcome measure will be assessed within 2 months</time_frame>
    <description>death</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Necrotizing Enterocolitis</condition>
  <arm_group>
    <arm_group_label>SAFE group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SAFE group: simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>SAFE group</intervention_name>
    <description>simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.</description>
    <arm_group_label>SAFE group</arm_group_label>
    <other_name>simulated amniotic fluid like solution 20cc/kg/day enterally</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>placebo group</intervention_name>
    <description>distilled water 20 ml/kg/day for maximum of 7 days.</description>
    <arm_group_label>Placebo</arm_group_label>
    <other_name>distilled water</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neonates with operable congenital bowel abnormalities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Critically ill babies.&#xD;
&#xD;
          -  Presence of any contraindications to enteral feeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rania A El-Farrash, MD</last_name>
    <role>Study Director</role>
    <affiliation>ASU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Rania A El-Farrash, MD</last_name>
    <phone>00201222208550</phone>
    <email>raniafarrash@hotmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Ain Shams University</name>
      <address>
        <city>Cairo</city>
        <zip>1138</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rania A El-Farrash, MD</last_name>
      <phone>00201222208550</phone>
      <email>raniafarrash@hotmail.com</email>
    </contact>
    <investigator>
      <last_name>safaa A El-aziz, Msc</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>May 17, 2015</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>September 30, 2017</last_update_submitted>
  <last_update_submitted_qc>September 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Rania Ali El-Farrash</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Feeding intolerance</keyword>
  <keyword>Simulated amniotic fluid like solution</keyword>
  <keyword>Necrotizing enterocolitis</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/NCT03302338
org study id: SAFE 2013
nct id: NCT03302338
lead sponsor: 
has dmc: Yes
Amniotic fluid plays a significant role in fetal gut maturation and development. The human
      fetus swallows over 200 ml of amniotic fluid per kilogram of weight each day and such
      swallowing is essential for normal small bowel development.Growth factors found in the
      amniotic fluid have been shown to promote proliferation of fetal intestinal cells. As feeding
      intolerance is a common problem among neonates recovering from surgery for congenital bowel
      abnormalities, the investigators will study the role of enteral administration of simulated
      amniotic fluid solution in prevention of feeding intolerance and NEC in neonates recovering
      from GIT surgeries.
Neonates with congenital GIT anomalies will participate after being operated.

      Participants will be followed for the duration of hospital stay until discharge or death.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Signs of feeding intolerance
time frame: through study completion, an average of 1 year
description: Feeding intolerance defined as distended loops of bowel, bilious vomiting, large pre-feeding gastric residuals more than 20% of each feed, diarrhea, occult or gross blood in stools, abdominal wall erythema or ecchymosis
measure: Necrotizing enterocolitis
time frame: The outcome measure will be assessed within 2 months
description: • Clinical signs of suspected NEC (abdominal distension, increased volume of gastric aspirate, bile stained aspirate, and / or apnea or bradycardia), and Bell's modified criteria for staging (Bell et al., 1978).
measure: hospital stay
time frame: through study completion, an average of 1 year
description: duration on hospitalization
measure: mortality
time frame: he outcome measure will be assessed within 2 months
description: death
arm group label: SAFE group
arm group type: Experimental
description: SAFE group: simulated amniotic fluid 20cc/kg/day enterally divided according to number of feds (syringe for every fed). This amount provides enteral 4.5μg rhG-CSF / kg/day and enteral 88IU rhEPO / kg/day.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo group: distilled water 2.5 ml/kg every 3 hours enterally given.
intervention type: Drug
intervention name: SAFE group
description: simulated amniotic fluid 20cc/kg/day enterally for a maximum of 7 days.
arm group label: SAFE group
other name: simulated amniotic fluid like solution 20cc/kg/day enterally
intervention type: Drug
intervention name: placebo group
description: distilled water 20 ml/kg/day for maximum of 7 days.
arm group label: Placebo
other name: distilled water
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
last name: Rania A El-Farrash, MD
role: Study Director
affiliation: ASU
last name: Rania A El-Farrash, MD
phone: 00201222208550
email: raniafarrash@hotmail.com
facility: 
status: Recruiting
contact: 
investigator: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Ain Shams University
investigator full name: Rania Ali El-Farrash
investigator title: Clinical Professor
mesh term: Enterocolitis
mesh term: Enterocolitis, Necrotizing