<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/NCT03035214</url>
  </required_header>
  <id_info>
    <org_study_id>MaadiPed001</org_study_id>
    <nct_id>NCT03035214</nct_id>
  </id_info>
  <brief_title>Study to Justify Steroid Use in Preterm Neonates to Prevent Bronchopulmonary Dysplasia</brief_title>
  <official_title>Single Arm Study on Treatment Algorithm to Justify Steroid Use in Selected Preterm Neonates to Prevent Bronchopulmonary Dysplasia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Maadi Military Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Maadi Military Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Most preterm babies require supplemental oxygen for a variable period of time, up to several&#xD;
      weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply&#xD;
      to the tissues without causing oxygen toxicity and oxidative stress. The current routine&#xD;
      monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying&#xD;
      pathology, as lung parenchyma and pulmonary vascular disease can be contributed in&#xD;
      pathophysiology at variable degrees.&#xD;
&#xD;
      Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have&#xD;
      adverse neurodevelopmental outcome. Available data are conflicting and inconclusive;&#xD;
      clinicians must use their own clinical judgment to balance the adverse effects of&#xD;
      Bronchopulmonary dysplasia with the potential adverse effects of treatments for each&#xD;
      individual patient. Very low birth weight infants who remain on mechanical ventilation after&#xD;
      1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.&#xD;
&#xD;
      When considering corticosteroid therapy for such an infant, clinicians might conclude that&#xD;
      the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia&#xD;
      are warranted.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective study. 30 Preterm infants admitted to neonatal intensive care units of&#xD;
      Maadi, Ghamra military hospitals, and Ain Shams University hospitals, will be prospectively&#xD;
      enrolled within 24 hours after birth. Daily evaluation of oxygen histograms with measurement&#xD;
      of the cumulative time of oxygen saturations below 80%, (risk of hypoxemia and potential&#xD;
      tissue hypoxia), and arterial oxygen saturations Sao2 above 95% (potential risk of hyperoxia&#xD;
      and increased oxidative stress). Evaluation window will be on a weekly basis as long as the&#xD;
      infant is on oxygen support and by applying oxygen tolerance test. The treating clinical team&#xD;
      will be blinded to all results of Oxygen tolerance test.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">February 19, 2017</start_date>
  <completion_date type="Anticipated">December 31, 2017</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2017</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Infant morbidity</measure>
    <time_frame>30 days</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>Prevention of dysplasia through steroids</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Failure of lung tolerance to oxygen reduction will be defined as oxygen saturation 80 to 87% for 5 minutes, or &lt;80% for 1 minute, then inspired oxygen will be increased back to the base line. This will be considered as an early predictor of evolving bronchopulmonary dysplasia. If there is no hypoventilation, dexamethasone will be given 0.25 mg/ kg/ d divided twice for 5 days intravenous.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone (Steroids)</intervention_name>
    <description>Is to describe the use of integrated assessment of respiratory physiology using Targeted Neonatal Echocardiography, assessment of optimal Functional Residual Capacity and the tolerance of lung oxygen uptake at different oxygen levels, and hence early prediction of Bronchopulmonary Dysplasia and the underlying pathophysiology by periodic application of the oxygen tolerance test; which may help early targeted treatment of this common disease.</description>
    <arm_group_label>Prevention of dysplasia through steroids</arm_group_label>
    <other_name>Dexamethasone</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        All preterm neonates admitted to the neonatal intensive care unit will be considered&#xD;
        eligible for inclusion. Fully informed written consent from parents of all eligible infants&#xD;
        will be sought prior to enrollment. Infants with major congenital abnormalities, cardiac&#xD;
        lesions other than Patent ductus arteriosus, and lung hypoplasia will be excluded from this&#xD;
        study.&#xD;
&#xD;
        Inclusion criteria:&#xD;
&#xD;
          -  &lt; 36 week gestation pre-terms, not having major congenital anomalies&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Congenital heart disease&#xD;
&#xD;
          -  Major congenital abnormalities&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>30 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Wael Hamza, MRCP</last_name>
    <email>EL_ZOERY_PERRY@HOTMAIL.COM</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Noha F Rashad</last_name>
    <phone>00201225157339</phone>
    <email>noha16880@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Maadi Military Hospital</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Noha F Rashad</last_name>
      <phone>00201225157339</phone>
      <email>noha16880@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>January 22, 2017</study_first_submitted>
  <study_first_submitted_qc>January 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 27, 2017</study_first_posted>
  <last_update_submitted>February 19, 2017</last_update_submitted>
  <last_update_submitted_qc>February 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">February 23, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Maadi Military Hospital</investigator_affiliation>
    <investigator_full_name>Dr. Wael Hamza</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Dexamethasone acetate</mesh_term>
    <mesh_term>BB 1101</mesh_term>
  </intervention_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/NCT03035214
org study id: MaadiPed001
nct id: NCT03035214
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Most preterm babies require supplemental oxygen for a variable period of time, up to several
      weeks or months after birth. The aim of oxygen therapy is to achieve adequate oxygen supply
      to the tissues without causing oxygen toxicity and oxidative stress. The current routine
      monitoring relies on oxygen saturation by pulse oximetry without identifying the underlying
      pathology, as lung parenchyma and pulmonary vascular disease can be contributed in
      pathophysiology at variable degrees.

      Steroids usage for prevention of Bronchopulmonary dysplasia also has been shown to have
      adverse neurodevelopmental outcome. Available data are conflicting and inconclusive;
      clinicians must use their own clinical judgment to balance the adverse effects of
      Bronchopulmonary dysplasia with the potential adverse effects of treatments for each
      individual patient. Very low birth weight infants who remain on mechanical ventilation after
      1 to 2 weeks of age are at very high risk of developing Bronchopulmonary dysplasia.

      When considering corticosteroid therapy for such an infant, clinicians might conclude that
      the risks of a short course of glucocorticoid therapy to prevent Bronchopulmonary dysplasia
      are warranted.
This is a prospective study. 30 Preterm infants admitted to neonatal intensive care units of
      Maadi, Ghamra military hospitals, and Ain Shams University hospitals, will be prospectively
      enrolled within 24 hours after birth. Daily evaluation of oxygen histograms with measurement
      of the cumulative time of oxygen saturations below 80%, (risk of hypoxemia and potential
      tissue hypoxia), and arterial oxygen saturations Sao2 above 95% (potential risk of hyperoxia
      and increased oxidative stress). Evaluation window will be on a weekly basis as long as the
      infant is on oxygen support and by applying oxygen tolerance test. The treating clinical team
      will be blinded to all results of Oxygen tolerance test.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Infant morbidity
time frame: 30 days
arm group label: Prevention of dysplasia through steroids
arm group type: Other
description: Failure of lung tolerance to oxygen reduction will be defined as oxygen saturation 80 to 87% for 5 minutes, or <80% for 1 minute, then inspired oxygen will be increased back to the base line. This will be considered as an early predictor of evolving bronchopulmonary dysplasia. If there is no hypoventilation, dexamethasone will be given 0.25 mg/ kg/ d divided twice for 5 days intravenous.
intervention type: Drug
intervention name: Dexamethasone (Steroids)
description: Is to describe the use of integrated assessment of respiratory physiology using Targeted Neonatal Echocardiography, assessment of optimal Functional Residual Capacity and the tolerance of lung oxygen uptake at different oxygen levels, and hence early prediction of Bronchopulmonary Dysplasia and the underlying pathophysiology by periodic application of the oxygen tolerance test; which may help early targeted treatment of this common disease.
arm group label: Prevention of dysplasia through steroids
other name: Dexamethasone
criteria: 
gender: All
minimum age: 1 Day
maximum age: 30 Days
healthy volunteers: No
last name: Wael Hamza, MRCP
email: EL_ZOERY_PERRY@HOTMAIL.COM
last name: Noha F Rashad
phone: 00201225157339
email: noha16880@gmail.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Maadi Military Hospital
investigator full name: Dr. Wael Hamza
investigator title: Principal investigator
mesh term: Bronchopulmonary Dysplasia
mesh term: Dexamethasone
mesh term: Dexamethasone acetate
mesh term: BB 1101
sharing ipd: No