<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/NCT03258528</url>
  </required_header>
  <id_info>
    <org_study_id>Neonatal Reflux</org_study_id>
    <nct_id>NCT03258528</nct_id>
  </id_info>
  <brief_title>Effect of Right Lateral Position on Ventilated Preterm Neonates</brief_title>
  <official_title>Effect of Right Lateral Position With Head Elevation on Tracheal Aspirate Pepsin in Ventilated Preterm Neonates: Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ain Shams University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ain Shams University</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>
      Objective: to evaluate the effect of right lateral positioning in comparison with supine&#xD;
      positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents&#xD;
      in ventilated preterm neonates. Study design: This randomized controlled trial was conducted&#xD;
      on 60 ventilated preterm neonates &lt; 35 weeks. They were randomized into 2 groups; one group&#xD;
      composed of 30 neonates that were nursed in right lateral position for 6 hours while the&#xD;
      other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal&#xD;
      aspirate sample was obtained from each neonate in both groups just after the end of 6 hours&#xD;
      and pepsin level was measured.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Objective: to evaluate the effect of right lateral positioning in comparison with supine&#xD;
      positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents&#xD;
      in ventilated preterm neonates. Study design: This randomized controlled trial was conducted&#xD;
      on 60 ventilated preterm neonates &lt; 35 weeks. They were randomized into 2 groups; one group&#xD;
      composed of 30 neonates that were nursed in right lateral position for 6 hours while the&#xD;
      other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal&#xD;
      aspirate sample was obtained from each neonate in both groups just after the end of 6 hours&#xD;
      and pepsin level was measured. Ventilatory settings were observed before and during the&#xD;
      intervention and neonates were followed up for development of bronchopulmpnary dysplasia&#xD;
      (BPD).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 5, 2016</start_date>
  <completion_date type="Actual">December 14, 2016</completion_date>
  <primary_completion_date type="Actual">December 14, 2016</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>
    <intervention_model_description>2</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>tracheal aspirate pepsin</measure>
    <time_frame>6 hours</time_frame>
    <description>Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Gastro Esophageal Reflux</condition>
  <arm_group>
    <arm_group_label>right lateral position group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neonates kept in the right lateral position for 6 hours with head tilted 30 degree upward with rolled towel supports the infant back at 90 degree angle on the bed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supine position group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Neonates kept in supine position for 6 hours with head tilted 30 degrees upward.&#xD;
Infants were fed while in their positions via feeding tube.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>positioning</intervention_name>
    <description>Positioning neonates for 6 hours either in right lateral position or supine position</description>
    <arm_group_label>right lateral position group</arm_group_label>
    <arm_group_label>supine position group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A total of 60 preterm neonates &lt; 35 weeks gestational age were enrolled in the study,&#xD;
             Inclusion criteria were tracheal intubated mechanically ventilated neonates for more&#xD;
             than 72 hours, feeding &gt;30ml/kg/day via nasogastric tube.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Neonates with perinatal asphyxia, intracranial hemorrhage grade 3 or 4,&#xD;
             periventricular leukomalacia, major congenital anomalies, gastrointestinal anomalies&#xD;
             such as tracheoesophageal fistula, or necrotizing enterocolitis , receiving xanthine&#xD;
             derivatives, H2 blockers, prokinetics, proton pump inhibitors or sedatives were&#xD;
             excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 22, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>August 22, 2017</last_update_submitted>
  <last_update_submitted_qc>August 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ain Shams University</investigator_affiliation>
    <investigator_full_name>Dina Mohamed Mohamed Shinkar</investigator_full_name>
    <investigator_title>Prinicpal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gastroesophageal Reflux</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03258528
org study id: Neonatal Reflux
nct id: NCT03258528
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: to evaluate the effect of right lateral positioning in comparison with supine
      positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents
      in ventilated preterm neonates. Study design: This randomized controlled trial was conducted
      on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group
      composed of 30 neonates that were nursed in right lateral position for 6 hours while the
      other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal
      aspirate sample was obtained from each neonate in both groups just after the end of 6 hours
      and pepsin level was measured.
Objective: to evaluate the effect of right lateral positioning in comparison with supine
      positioning on tracheal aspirate pepsin levels as a marker of aspiration of gastric contents
      in ventilated preterm neonates. Study design: This randomized controlled trial was conducted
      on 60 ventilated preterm neonates < 35 weeks. They were randomized into 2 groups; one group
      composed of 30 neonates that were nursed in right lateral position for 6 hours while the
      other group composed of 30 neonates that were nursed in supine position for 6 hours. Tracheal
      aspirate sample was obtained from each neonate in both groups just after the end of 6 hours
      and pepsin level was measured. Ventilatory settings were observed before and during the
      intervention and neonates were followed up for development of bronchopulmpnary dysplasia
      (BPD).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: 2
primary purpose: Prevention
masking: None (Open Label)
measure: tracheal aspirate pepsin
time frame: 6 hours
description: Tracheal aspirate sample was obtained from each neonate in both groups just after the end of 6 hours and pepsin level was measured
arm group label: right lateral position group
arm group type: Active Comparator
description: Neonates kept in the right lateral position for 6 hours with head tilted 30 degree upward with rolled towel supports the infant back at 90 degree angle on the bed.
arm group label: supine position group
arm group type: Active Comparator
description: Neonates kept in supine position for 6 hours with head tilted 30 degrees upward.
Infants were fed while in their positions via feeding tube.
intervention type: Behavioral
intervention name: positioning
description: Positioning neonates for 6 hours either in right lateral position or supine position
arm group label: right lateral position group
arm group label: supine position group
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Ain Shams University
investigator full name: Dina Mohamed Mohamed Shinkar
investigator title: Prinicpal investigator
mesh term: Gastroesophageal Reflux
sharing ipd: Undecided