<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/NCT03748472</url>
  </required_header>
  <id_info>
    <org_study_id>Feeding length and oxygenation</org_study_id>
    <nct_id>NCT03748472</nct_id>
  </id_info>
  <brief_title>The Effect of Feeding Length on the Oxygenation Instability Among Premature Infants</brief_title>
  <official_title>The Effects of Bolus Feeding as Compared to Continuous Gavage Feeding on the Oxygenation Instability During Feeds Among Premature Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rambam Health Care Campus</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rambam Health Care Campus</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>
      SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously&#xD;
      in many of these infants, especially after the first week of life. Different interventions&#xD;
      have been shown to influence the incidence of hypoxemic episodes in premature infants.&#xD;
      Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation&#xD;
      instability among premature infants therefore the aim of this study is to evaluate the&#xD;
      changes in oxygenation among preterm infants receiving respiratory support when are fed over&#xD;
      30 min vs over 2 hours, as documented by SpO2 histograms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2019</start_date>
  <completion_date type="Actual">March 1, 2022</completion_date>
  <primary_completion_date type="Actual">December 13, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation instability</measure>
    <time_frame>9 hours (3 feeds)</time_frame>
    <description>SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Premature Infant</condition>
  <condition>Respiratory Disease</condition>
  <arm_group>
    <arm_group_label>Bolus feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>continuous gavage feeding</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Continuous gavage feeding</intervention_name>
    <description>Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.</description>
    <arm_group_label>continuous gavage feeding</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bolus feeding</intervention_name>
    <description>Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.</description>
    <arm_group_label>Bolus feeding</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Premature Infants (GA&lt;37weeks) on non-invasive respiratory support (CPAP, NIPPV, HFNC)&#xD;
        Feeding&gt;100 ml/kg/day&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Congenital anomalies e.g. gastroschesis, congenital diaphragmatic hernia, cyanotic heart&#xD;
        disease.&#xD;
&#xD;
        Instability because of:&#xD;
&#xD;
        Acute lung pathology for example x-ray confirmed pneumonia, air leak Active culture proven&#xD;
        sepsis Need for inotropic support for low blood pressure&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rambam Medical Center</name>
      <address>
        <city>Haifa</city>
        <country>Israel</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Israel</country>
  </location_countries>
  <verification_date>April 2022</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 20, 2018</study_first_posted>
  <last_update_submitted>April 27, 2022</last_update_submitted>
  <last_update_submitted_qc>April 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rambam Health Care Campus</investigator_affiliation>
    <investigator_full_name>Liron Borenstein MD</investigator_full_name>
    <investigator_title>Neonatologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Diseases</mesh_term>
    <mesh_term>Respiration Disorders</mesh_term>
    <mesh_term>Premature Birth</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/NCT03748472
org study id: Feeding length and oxygenation
nct id: NCT03748472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
SpO2 instability is in the nature of premature infants. Hypoxic episodes occur spontaneously
      in many of these infants, especially after the first week of life. Different interventions
      have been shown to influence the incidence of hypoxemic episodes in premature infants.
      Premature infants are fed via an NG/OG tube. Feeding length might influence the oxygenation
      instability among premature infants therefore the aim of this study is to evaluate the
      changes in oxygenation among preterm infants receiving respiratory support when are fed over
      30 min vs over 2 hours, as documented by SpO2 histograms.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Oxygenation instability
time frame: 9 hours (3 feeds)
description: SPO2 histogram documents the oxygenation stability. we will record the histogram at the end of each period of time and compare it
arm group label: Bolus feeding
arm group type: Experimental
arm group label: continuous gavage feeding
arm group type: Experimental
intervention type: Procedure
intervention name: Continuous gavage feeding
description: Each subject will serve as his or her own control. In this arm infants will receive their feed over 2 hours and the next feed will be given over 30 min and then over 2 hours again.
arm group label: continuous gavage feeding
intervention type: Procedure
intervention name: Bolus feeding
description: Each subject will serve as his or her own control. In this arm infants will receive their feed over 30 min and the next feed will be given over 2 hours and then over 30 minutes again.
arm group label: Bolus feeding
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Israel
responsible party type: Principal Investigator
investigator affiliation: Rambam Health Care Campus
investigator full name: Liron Borenstein MD
investigator title: Neonatologist
mesh term: Respiratory Tract Diseases
mesh term: Respiration Disorders
mesh term: Premature Birth
sharing ipd: Undecided