<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/NCT03808402</url>
  </required_header>
  <id_info>
    <org_study_id>IRAS 237111</org_study_id>
    <secondary_id>36652</secondary_id>
    <nct_id>NCT03808402</nct_id>
  </id_info>
  <brief_title>The Effect of Surfactant Dose on Outcomes in Preterm Infants With RDS</brief_title>
  <acronym>OPTI-SURF</acronym>
  <official_title>The Effect of Surfactant Dose on Outcomes in Preterm Infants With Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chiesi UK</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>The Leeds Teaching Hospitals NHS Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Imperial College London</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Chiesi UK</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>
      A prospective observational study using de-identified data from the Neonatal Network Research&#xD;
      Database (NNRD) supplemented by additional information on dose, method of surfactant&#xD;
      administration and dosing frequency to assess whether the dose and method of administration&#xD;
      of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects&#xD;
      neonatal outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rationale for this study is the clinical relevance of understanding whether surfactant&#xD;
      dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal&#xD;
      period.&#xD;
&#xD;
      In a research environment, the dose of surfactant is rigorously controlled, usually&#xD;
      administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more&#xD;
      frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get&#xD;
      as close as possible to the desired dose. Reasons for whole vial use include reduction of&#xD;
      waste and administration of surfactant shortly after birth where an infant's weight is&#xD;
      unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and&#xD;
      whether either situation affects outcomes.&#xD;
&#xD;
      Information regarding the dose of surfactant delivered, and the method of administration, are&#xD;
      not currently routinely recorded in the UK.&#xD;
&#xD;
      The primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200&#xD;
      mg/kg) in terms of the proportions of infants who require mechanical ventilation within four&#xD;
      days of birth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 26, 2018</start_date>
  <completion_date type="Anticipated">January 30, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2024</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Need for mechanical ventilation</measure>
    <time_frame>Day 3 to 4 of life</time_frame>
    <description>Survival without mechanical ventilation (excluding days 1 and 2 of life)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Survival</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of doses of surfactant</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total cumulative dose of surfactant (excluding the first dose)</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival with no respiratory support</measure>
    <time_frame>On postnatal day 28</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival with no respiratory support</measure>
    <time_frame>36 weeks gestation</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Survival with no oxygen requirement</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of mechanical ventilation (days)</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of respiratory support (days)</measure>
    <time_frame>To study completion, an average of 2 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-year developmental outcomes</measure>
    <time_frame>Two years</time_frame>
    <description>As measured by Bailey's Score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Two-year developmental outcomes</measure>
    <time_frame>Two years</time_frame>
    <description>As measured by Composite Developmental Assessment</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)</measure>
    <time_frame>Day 3 to 4 of life</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)</measure>
    <time_frame>Day 3 to 4 of life</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">2973</enrollment>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>High dose surfactant</arm_group_label>
    <description>Infants who receive a first dose of surfactant between 170 and 200 mg/kg</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dose surfactant</arm_group_label>
    <description>Infants who receive a first dose of surfactant between 100 and 130 mg/kg</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Newborn infants born in neonatal units in the UK&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  &lt;37 weeks gestational age Requiring surfactant for Respiratory Distress Syndrome&#xD;
             Record of birth weight available Born after study initiation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  37 weeks gestation age or above Parental opt-out&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kevin Goss, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Leeds Teaching Hospitals NHS Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>William Harvey Hospital</name>
      <address>
        <city>Ashford</city>
        <state>Kent</state>
        <zip>TN24 0LZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmingham Women's Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B15 2TG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Birmigham Heartlands Hospital</name>
      <address>
        <city>Birmingham</city>
        <zip>B9 5SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Bolton Hospital</name>
      <address>
        <city>Bolton</city>
        <zip>BL4 0JR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bradford Royal Infirmary</name>
      <address>
        <city>Bradford</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Burnley General Hospital</name>
      <address>
        <city>Burnley</city>
        <zip>BB10</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Rosie Hospital</name>
      <address>
        <city>Cambridge</city>
        <zip>CB2 0SW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Peter's Hospital</name>
      <address>
        <city>Chertsey</city>
        <zip>KT16 0PZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Coventry</name>
      <address>
        <city>Coventry</city>
        <zip>CV2 2DX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hull Royal Infirmary</name>
      <address>
        <city>Hull</city>
        <zip>HU3 2JZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leeds General Infirmary</name>
      <address>
        <city>Leeds</city>
        <zip>LS1 3EX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Leicester Royal Infirmary</name>
      <address>
        <city>Leicester</city>
        <zip>LE1 5WW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Liverpool Women's Hospital</name>
      <address>
        <city>Liverpool</city>
        <zip>L8 7SS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Homerton Hospital</name>
      <address>
        <city>London</city>
        <zip>E9 6SR</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University College Hospital</name>
      <address>
        <city>London</city>
        <zip>NW1 2BU'</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Guy's and St Thomas' Hospital</name>
      <address>
        <city>London</city>
        <zip>SE1 7EH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chelsea and Westminster Hospital</name>
      <address>
        <city>London</city>
        <zip>SW10 9NH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13 9WL</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wythenshawe Hospital</name>
      <address>
        <city>Manchester</city>
        <zip>M13</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The James Cook Hospital</name>
      <address>
        <city>Middlesbrough</city>
        <zip>TS4 3BW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital of North Tees</name>
      <address>
        <city>Middlesbrough</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Victoria Infirmary</name>
      <address>
        <city>Newcastle</city>
        <zip>Ne1 4LP</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Norfolk and Norwich University Hospital</name>
      <address>
        <city>Norwich</city>
        <zip>NR4 7UY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queens Medical Centre</name>
      <address>
        <city>Nottingham</city>
        <zip>NG7 2UH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Royal Oldham Hospital</name>
      <address>
        <city>Oldham</city>
        <zip>OL1 2JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>John Radcliffe Hospital</name>
      <address>
        <city>Oxford</city>
        <zip>OX3 9DU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Queen Alexandra Hospital</name>
      <address>
        <city>Portsmouth</city>
        <zip>PO6 3LY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jessop Wing</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2SF</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Princess Anne Hospital</name>
      <address>
        <city>Southampton</city>
        <zip>SO16 6YD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://www.leedsth.nhs.uk/research/clinical-trials/optisurf/</url>
    <description>Study website</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 17, 2019</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 2, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Surfactant</keyword>
  <keyword>Less Invasive Surfactant Administration</keyword>
  <keyword>Mechanical Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plan to share IPD</ipd_description>
  </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/NCT03808402
org study id: IRAS 237111
secondary id: 36652
nct id: NCT03808402
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective observational study using de-identified data from the Neonatal Network Research
      Database (NNRD) supplemented by additional information on dose, method of surfactant
      administration and dosing frequency to assess whether the dose and method of administration
      of surfactant given to preterm infants with respiratory distress syndrome (RDS) affects
      neonatal outcomes.
The rationale for this study is the clinical relevance of understanding whether surfactant
      dose affects neonatal outcomes in infants with RDS who are treated in the immediate postnatal
      period.

      In a research environment, the dose of surfactant is rigorously controlled, usually
      administered at a dose of 100mg/kg or 200mg/kg. In clinical practice, clinicians more
      frequently follow the 'whole vial dosing' approach, where a full vial is given aiming to get
      as close as possible to the desired dose. Reasons for whole vial use include reduction of
      waste and administration of surfactant shortly after birth where an infant's weight is
      unknown. It is unclear whether whole vial dosing leads to under-dosing or over-dosing and
      whether either situation affects outcomes.

      Information regarding the dose of surfactant delivered, and the method of administration, are
      not currently routinely recorded in the UK.

      The primary objective of the study is to compare two dosing groups (100-130 mg/kg and 170-200
      mg/kg) in terms of the proportions of infants who require mechanical ventilation within four
      days of birth.
observational model: Cohort
time perspective: Prospective
measure: Need for mechanical ventilation
time frame: Day 3 to 4 of life
description: Survival without mechanical ventilation (excluding days 1 and 2 of life)
measure: Survival
time frame: To study completion, an average of 2 years
measure: Number of doses of surfactant
time frame: To study completion, an average of 2 years
measure: Total cumulative dose of surfactant (excluding the first dose)
time frame: To study completion, an average of 2 years
measure: Survival with no respiratory support
time frame: On postnatal day 28
measure: Survival with no respiratory support
time frame: 36 weeks gestation
measure: Survival with no oxygen requirement
time frame: To study completion, an average of 2 years
measure: Duration of mechanical ventilation (days)
time frame: To study completion, an average of 2 years
measure: Duration of respiratory support (days)
time frame: To study completion, an average of 2 years
measure: Two-year developmental outcomes
time frame: Two years
description: As measured by Bailey's Score
measure: Two-year developmental outcomes
time frame: Two years
description: As measured by Composite Developmental Assessment
measure: Effect of dose on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
time frame: Day 3 to 4 of life
measure: Effect of method of administration on need for mechanical ventilation on days 3 and 4 (excluding days 1 and 2)
time frame: Day 3 to 4 of life
arm group label: High dose surfactant
description: Infants who receive a first dose of surfactant between 170 and 200 mg/kg
arm group label: Low dose surfactant
description: Infants who receive a first dose of surfactant between 100 and 130 mg/kg
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kevin Goss, MBBS
role: Principal Investigator
affiliation: Leeds Teaching Hospitals NHS Trust
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country: United Kingdom
url: https://www.leedsth.nhs.uk/research/clinical-trials/optisurf/
description: Study website
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Bronchopulmonary Dysplasia
mesh term: Syndrome
sharing ipd: No
ipd description: No plan to share IPD