xml: <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/NCT06007547</url>
    </required_header>
    <id_info>
      <org_study_id>EH23-107</org_study_id>
      <nct_id>NCT06007547</nct_id>
    </id_info>
    <brief_title>Prophylactic Minimally Invasive Surfactant Evaluation</brief_title>
    <acronym>PreProMISe</acronym>
    <official_title>Prophylactic Minimally Invasive Surfactant Evaluation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>NorthShore University HealthSystem</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>NorthShore University HealthSystem</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to explore the question: Does prophylactic administration of&#xD;
        exogenous surfactant in the delivery room, using a minimally-invasive technique, improve&#xD;
        outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same&#xD;
        technique?&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        RESEARCH DESIGN Multicenter, randomized, controlled trial.&#xD;
  &#xD;
        Northshore Evanston Hospital will be the primary site. It is hoped that Northwest Community,&#xD;
        University of Chicago, Edwards Hospital, Advocate Park Ridge, Advocate Oak Lawn and Advocate&#xD;
        Illinois Masonic will also join the study.&#xD;
  &#xD;
        RECRUITMENT Entry criteria Inborn preterm infants 22 0/7-29 6/7 weeks' gestation, with be&#xD;
        randomized to prophylactic Minimally Invasive Surfactant Therapy (MIST) in the delivery room&#xD;
        compared to rescue MIST if fraction of inspired oxygen (FiO2) ≥0.30 at less than 48 hours of&#xD;
        age. Babies in both groups will be managed on nasal continuous positive airway pressure&#xD;
        (NCPAP) pressures of 5-8 cm water.&#xD;
  &#xD;
        Exclusion criteria Infants will be excluded if there is a congenital anomaly or an&#xD;
        alternative cause for respiratory distress.&#xD;
  &#xD;
        Babies who require emergent intubation in the delivery room will not be enrolled in the&#xD;
        interventions.&#xD;
  &#xD;
        Parental Consent will be obtained prior to birth. Once delivery is imminent infant will be&#xD;
        randomized to immediate versus rescue surfactant administration via MIST. Randomization will&#xD;
        be in blocks of 6 and using cards with created by a web based randomizer.&#xD;
  &#xD;
        Infants who require emergent intubation in the delivery room will not be enrolled in the&#xD;
        interventions but their clinical outcomes will be assessed the same as the babies who receive&#xD;
        the intervention.&#xD;
  &#xD;
        There will be three gestational age strata (22-23 weeks, 24-26 weeks and 27-29 weeks). Twins&#xD;
        and higher order multiples will be randomized independently. Babies in the lowest gestational&#xD;
        age strata will not be enrolled at a center until 5 babies at that center have been enrolled&#xD;
        in either of the other groups.&#xD;
  &#xD;
        INTERVENTION Infants randomized to prophylactic surfactant treatment will receive a dose of&#xD;
        poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant&#xD;
        instillation catheter (MIST) 16 Gauge Angiocath (Becton Dickinson, Sandy, UT, USA), at a&#xD;
        dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes). The infants will&#xD;
        be stabilized and placed on NCPAP or High flow Nasal Cannula (HFNC).&#xD;
  &#xD;
        Briefly the MIST procedure is as follows: the angiocath is inserted to an appropriate depth&#xD;
        under direct laryngoscopy, the laryngoscope is removed, a carbon dioxide (CO2) detector is&#xD;
        placed on the end of the catheter with a endotracheal tube adaptor. If the color changes then&#xD;
        adaptor and detector are removed and the surfactant is instilled over about 1 minute and the&#xD;
        catheter is removed. The infant is maintained on NCPAP/HFNC during the procedure.&#xD;
  &#xD;
        Infants of both groups will be supported via HFNC or NCPAP in the delivery room and then&#xD;
        transitioned to NCPAP in the neonatal intensive care unit (NICU).&#xD;
  &#xD;
        The control group will be given surfactant via MIST if their fiO2 reaches a threshold of ≥30%&#xD;
        within the first 48 hours of life.&#xD;
  &#xD;
        A second dose of poractant alfa (Curosurf), at a dosage of 100mg/kg, will be administered via&#xD;
        MIST to both groups if their fiO2 reaches the threshold of 30% between 6 and 48 hours after&#xD;
        the first dose.&#xD;
  &#xD;
        No further surfactant should be given in the first 7 days unless the infant reaches the&#xD;
        intubation criteria.&#xD;
  &#xD;
        POST-INTERVENTION MANAGEMENT Other than the requirement to adhere to intubation criteria in&#xD;
        the first week, and in some cases perform a room air trial at 36 weeks corrected gestation,&#xD;
        management will be at the discretion of the clinical team.&#xD;
  &#xD;
        Titration of CPAP pressure is encouraged, with a permitted maximum of 8 cm H2O. Use of nasal&#xD;
        intermittent positive-pressure ventilation (NIPPV) is allowable for apnea, but discouraged&#xD;
        for Respiratory Distress Syndrome (RDS) and should only be after at least one dose of&#xD;
        surfactant has been given.&#xD;
  &#xD;
        Early caffeine therapy is expected.&#xD;
  &#xD;
        Criteria for intubation:&#xD;
  &#xD;
        Enrolled infants on CPAP will be intubated if:&#xD;
  &#xD;
          -  FiO2 ≥0.45 for 15 minutes, or if there is unremitting apnea (&gt; 6 episodes/hour requiring&#xD;
             intervention or in the opinion of the treating physician) or persistent respiratory&#xD;
             acidosis (pH&lt;7.25 and partial pressure of carbon dioxide (pCO2) &gt;60) on blood gasses at&#xD;
             least 30 minutes apart or metabolic acidosis refractory to treatment.&#xD;
  &#xD;
          -  Need for an anesthetic or an intervention requiring intubation&#xD;
  &#xD;
        These criteria apply during the first week of life, and to the first episode of intubation&#xD;
        only. If the infant is intubated it is expected that another dose of surfactant will be&#xD;
        administered.&#xD;
  &#xD;
        OUTCOMES Primary outcome: Intubation in the first 7 days of age.&#xD;
  &#xD;
        Secondary outcomes:&#xD;
  &#xD;
          -  Respiratory Incidence of composite outcome of death or physiological bronchopulmonary&#xD;
             dysplasia (BPD). Durations of mechanical respiratory support, CPAP, high flow nasal&#xD;
             cannula, (HFNC), oxygen therapy. Pneumothorax or pulmonary hemorrhage.&#xD;
  &#xD;
          -  Non respiratory neonatal morbidities intraventricular hemorrhage, periventricular&#xD;
             leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, and patent ductus&#xD;
             arteriosus. Corrected age at discharge, length of hospital stay (a proxy for cost).&#xD;
             Neonatal follow up data.&#xD;
  &#xD;
        The above data will be collected until discharge. Babies born between 22 and 29 weeks are&#xD;
        routinely followed by our developmental follow up clinic. The information from the 2-year&#xD;
        developmental clinic visit will be recorded by the study.&#xD;
  &#xD;
        SAMPLE SIZE 200, 50 being from NorthShore. Between 2018 and 2022 65% of the babies in this&#xD;
        gestational age had an endotracheal tube inserted at Evanston Hospital, and were ventilated.&#xD;
        Detection of a reduction of 25% (from 65% to 40%) with a 90% power and α = 0.05 (two-sided)&#xD;
        would require 82 subjects per arm. It is anticipated that patient recruitment should take 2&#xD;
        years.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">July 31, 2027</completion_date>
    <primary_completion_date type="Anticipated">July 31, 2025</primary_completion_date>
    <phase>Phase 4</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>Comparison of prophylaxis compared to rescue surfactant, administered using a minimally invasive technique, in premature infants less that 30 weeks gestation</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Endotracheal Intubation</measure>
      <time_frame>7 days</time_frame>
      <description>Oxygen requirement &gt; 45% requiring endotracheal intubation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Bronchopulmonary dysplasia</measure>
      <time_frame>36 weeks corrected gestational age</time_frame>
      <description>Oxygen requirement to 36 weeks corrected age</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">200</enrollment>
    <condition>Respiratory Distress Syndrome, Newborn</condition>
    <condition>Premature Birth</condition>
    <arm_group>
      <arm_group_label>Prophylactic Surfactant via Minimally Invasive Technique</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Rescue Surfactant via Minimally Invasive Technique</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Poractant Alfa</intervention_name>
      <description>Poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg</description>
      <arm_group_label>Prophylactic Surfactant via Minimally Invasive Technique</arm_group_label>
      <arm_group_label>Rescue Surfactant via Minimally Invasive Technique</arm_group_label>
      <other_name>Minimally Invasive Surfactant Therapy</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Gestational age &lt;30 weeks&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Congenital anomalies&#xD;
  &#xD;
            -  Alternate cause of respiratory distress&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>0 Minutes</minimum_age>
      <maximum_age>15 Minutes</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Matthew Derrick, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Northshore Univ Healthsystem</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Matthew Derrick, MBBS</last_name>
      <phone>8475702920</phone>
      <email>mderrick@northshore.org</email>
    </overall_contact>
    <location>
      <facility>
        <name>Northshore University Healthsystem</name>
        <address>
          <city>Evanston</city>
          <state>Illinois</state>
          <zip>60201</zip>
          <country>United States</country>
        </address>
      </facility>
      <contact>
        <last_name>Matthew Derrick, mbbs</last_name>
        <phone>847-570-2920</phone>
        <email>mderrick@northshore.org</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.</citation>
      <PMID>34902013</PMID>
    </reference>
    <reference>
      <citation>Kendig JW, Notter RH, Cox C, Reubens LJ, Davis JM, Maniscalco WM, Sinkin RA, Bartoletti A, Dweck HS, Horgan MJ, et al. A comparison of surfactant as immediate prophylaxis and as rescue therapy in newborns of less than 30 weeks' gestation. N Engl J Med. 1991 Mar 28;324(13):865-71. doi: 10.1056/NEJM199103283241301.</citation>
      <PMID>2000109</PMID>
    </reference>
    <reference>
      <citation>Kribs A, Hartel C, Kattner E, Vochem M, Kuster H, Moller J, Muller D, Segerer H, Wieg C, Gebauer C, Nikischin W, Wense Av, Herting E, Roth B, Gopel W. Surfactant without intubation in preterm infants with respiratory distress: first multi-center data. Klin Padiatr. 2010 Jan-Feb;222(1):13-7. doi: 10.1055/s-0029-1241867. Epub 2010 Jan 18.</citation>
      <PMID>20084586</PMID>
    </reference>
    <reference>
      <citation>Kattwinkel J, Bloom BT, Delmore P, Davis CL, Farrell E, Friss H, Jung AL, King K, Mueller D. Prophylactic administration of calf lung surfactant extract is more effective than early treatment of respiratory distress syndrome in neonates of 29 through 32 weeks' gestation. Pediatrics. 1993 Jul;92(1):90-8.</citation>
      <PMID>8516091</PMID>
    </reference>
    <reference>
      <citation>SUPPORT Study Group of the Eunice Kennedy Shriver NICHD Neonatal Research Network; Finer NN, Carlo WA, Walsh MC, Rich W, Gantz MG, Laptook AR, Yoder BA, Faix RG, Das A, Poole WK, Donovan EF, Newman NS, Ambalavanan N, Frantz ID 3rd, Buchter S, Sanchez PJ, Kennedy KA, Laroia N, Poindexter BB, Cotten CM, Van Meurs KP, Duara S, Narendran V, Sood BG, O'Shea TM, Bell EF, Bhandari V, Watterberg KL, Higgins RD. Early CPAP versus surfactant in extremely preterm infants. N Engl J Med. 2010 May 27;362(21):1970-9. doi: 10.1056/NEJMoa0911783. Epub 2010 May 16. Erratum In: N Engl J Med. 2010 Jun 10;362(23):2235.</citation>
      <PMID>20472939</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 27, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>NorthShore University HealthSystem</investigator_affiliation>
      <investigator_full_name>Matthew Derrick</investigator_full_name>
      <investigator_title>Attending Neonatologist</investigator_title>
    </responsible_party>
    <keyword>Respiratory Distress Syndrome</keyword>
    <keyword>surfactant</keyword>
    <keyword>Minimally invasive Surfactant Therapy</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>Premature Birth</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Poractant alfa</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06007547
  org study id: EH23-107
  nct id: NCT06007547
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: Yes
  The purpose of this study is to explore the question: Does prophylactic administration of
        exogenous surfactant in the delivery room, using a minimally-invasive technique, improve
        outcome in preterm infants 22-29 weeks' gestation compared to rescue treatment using the same
        technique?
  RESEARCH DESIGN Multicenter, randomized, controlled trial.
  
        Northshore Evanston Hospital will be the primary site. It is hoped that Northwest Community,
        University of Chicago, Edwards Hospital, Advocate Park Ridge, Advocate Oak Lawn and Advocate
        Illinois Masonic will also join the study.
  
        RECRUITMENT Entry criteria Inborn preterm infants 22 0/7-29 6/7 weeks' gestation, with be
        randomized to prophylactic Minimally Invasive Surfactant Therapy (MIST) in the delivery room
        compared to rescue MIST if fraction of inspired oxygen (FiO2) ≥0.30 at less than 48 hours of
        age. Babies in both groups will be managed on nasal continuous positive airway pressure
        (NCPAP) pressures of 5-8 cm water.
  
        Exclusion criteria Infants will be excluded if there is a congenital anomaly or an
        alternative cause for respiratory distress.
  
        Babies who require emergent intubation in the delivery room will not be enrolled in the
        interventions.
  
        Parental Consent will be obtained prior to birth. Once delivery is imminent infant will be
        randomized to immediate versus rescue surfactant administration via MIST. Randomization will
        be in blocks of 6 and using cards with created by a web based randomizer.
  
        Infants who require emergent intubation in the delivery room will not be enrolled in the
        interventions but their clinical outcomes will be assessed the same as the babies who receive
        the intervention.
  
        There will be three gestational age strata (22-23 weeks, 24-26 weeks and 27-29 weeks). Twins
        and higher order multiples will be randomized independently. Babies in the lowest gestational
        age strata will not be enrolled at a center until 5 babies at that center have been enrolled
        in either of the other groups.
  
        INTERVENTION Infants randomized to prophylactic surfactant treatment will receive a dose of
        poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant
        instillation catheter (MIST) 16 Gauge Angiocath (Becton Dickinson, Sandy, UT, USA), at a
        dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes). The infants will
        be stabilized and placed on NCPAP or High flow Nasal Cannula (HFNC).
  
        Briefly the MIST procedure is as follows: the angiocath is inserted to an appropriate depth
        under direct laryngoscopy, the laryngoscope is removed, a carbon dioxide (CO2) detector is
        placed on the end of the catheter with a endotracheal tube adaptor. If the color changes then
        adaptor and detector are removed and the surfactant is instilled over about 1 minute and the
        catheter is removed. The infant is maintained on NCPAP/HFNC during the procedure.
  
        Infants of both groups will be supported via HFNC or NCPAP in the delivery room and then
        transitioned to NCPAP in the neonatal intensive care unit (NICU).
  
        The control group will be given surfactant via MIST if their fiO2 reaches a threshold of ≥30%
        within the first 48 hours of life.
  
        A second dose of poractant alfa (Curosurf), at a dosage of 100mg/kg, will be administered via
        MIST to both groups if their fiO2 reaches the threshold of 30% between 6 and 48 hours after
        the first dose.
  
        No further surfactant should be given in the first 7 days unless the infant reaches the
        intubation criteria.
  
        POST-INTERVENTION MANAGEMENT Other than the requirement to adhere to intubation criteria in
        the first week, and in some cases perform a room air trial at 36 weeks corrected gestation,
        management will be at the discretion of the clinical team.
  
        Titration of CPAP pressure is encouraged, with a permitted maximum of 8 cm H2O. Use of nasal
        intermittent positive-pressure ventilation (NIPPV) is allowable for apnea, but discouraged
        for Respiratory Distress Syndrome (RDS) and should only be after at least one dose of
        surfactant has been given.
  
        Early caffeine therapy is expected.
  
        Criteria for intubation:
  
        Enrolled infants on CPAP will be intubated if:
  
          -  FiO2 ≥0.45 for 15 minutes, or if there is unremitting apnea (> 6 episodes/hour requiring
             intervention or in the opinion of the treating physician) or persistent respiratory
             acidosis (pH<7.25 and partial pressure of carbon dioxide (pCO2) >60) on blood gasses at
             least 30 minutes apart or metabolic acidosis refractory to treatment.
  
          -  Need for an anesthetic or an intervention requiring intubation
  
        These criteria apply during the first week of life, and to the first episode of intubation
        only. If the infant is intubated it is expected that another dose of surfactant will be
        administered.
  
        OUTCOMES Primary outcome: Intubation in the first 7 days of age.
  
        Secondary outcomes:
  
          -  Respiratory Incidence of composite outcome of death or physiological bronchopulmonary
             dysplasia (BPD). Durations of mechanical respiratory support, CPAP, high flow nasal
             cannula, (HFNC), oxygen therapy. Pneumothorax or pulmonary hemorrhage.
  
          -  Non respiratory neonatal morbidities intraventricular hemorrhage, periventricular
             leukomalacia, retinopathy of prematurity, necrotizing enterocolitis, and patent ductus
             arteriosus. Corrected age at discharge, length of hospital stay (a proxy for cost).
             Neonatal follow up data.
  
        The above data will be collected until discharge. Babies born between 22 and 29 weeks are
        routinely followed by our developmental follow up clinic. The information from the 2-year
        developmental clinic visit will be recorded by the study.
  
        SAMPLE SIZE 200, 50 being from NorthShore. Between 2018 and 2022 65% of the babies in this
        gestational age had an endotracheal tube inserted at Evanston Hospital, and were ventilated.
        Detection of a reduction of 25% (from 65% to 40%) with a 90% power and α = 0.05 (two-sided)
        would require 82 subjects per arm. It is anticipated that patient recruitment should take 2
        years.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Comparison of prophylaxis compared to rescue surfactant, administered using a minimally invasive technique, in premature infants less that 30 weeks gestation
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Endotracheal Intubation
  time frame: 7 days
  description: Oxygen requirement > 45% requiring endotracheal intubation
  measure: Bronchopulmonary dysplasia
  time frame: 36 weeks corrected gestational age
  description: Oxygen requirement to 36 weeks corrected age
  arm group label: Prophylactic Surfactant via Minimally Invasive Technique
  arm group type: Experimental
  description: Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes).
  arm group label: Rescue Surfactant via Minimally Invasive Technique
  arm group type: Active Comparator
  description: The control group will be given surfactant will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg if their fiO2 reaches a threshold of ≥30% within the first 48 hours of life.
  intervention type: Drug
  intervention name: Poractant Alfa
  description: Poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16G Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg
  arm group label: Prophylactic Surfactant via Minimally Invasive Technique
  arm group label: Rescue Surfactant via Minimally Invasive Technique
  other name: Minimally Invasive Surfactant Therapy
  criteria: 
  gender: All
  minimum age: 0 Minutes
  maximum age: 15 Minutes
  healthy volunteers: Accepts Healthy Volunteers
  last name: Matthew Derrick, MBBS
  role: Principal Investigator
  affiliation: Northshore Univ Healthsystem
  last name: Matthew Derrick, MBBS
  phone: 8475702920
  email: mderrick@northshore.org
  facility: 
  contact: 
  country: United States
  citation: Dargaville PA, Kamlin COF, Orsini F, Wang X, De Paoli AG, Kanmaz Kutman HG, Cetinkaya M, Kornhauser-Cerar L, Derrick M, Ozkan H, Hulzebos CV, Schmolzer GM, Aiyappan A, Lemyre B, Kuo S, Rajadurai VS, O'Shea J, Biniwale M, Ramanathan R, Kushnir A, Bader D, Thomas MR, Chakraborty M, Buksh MJ, Bhatia R, Sullivan CL, Shinwell ES, Dyson A, Barker DP, Kugelman A, Donovan TJ, Tauscher MK, Murthy V, Ali SKM, Yossuck P, Clark HW, Soll RF, Carlin JB, Davis PG; OPTIMIST-A Trial Investigators. Effect of Minimally Invasive Surfactant Therapy vs Sham Treatment on Death or Bronchopulmonary Dysplasia in Preterm Infants With Respiratory Distress Syndrome: The OPTIMIST-A Randomized Clinical Trial. JAMA. 2021 Dec 28;326(24):2478-2487. doi: 10.1001/jama.2021.21892.
  PMID: 34902013
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  PMID: 20472939
  responsible party type: Principal Investigator
  investigator affiliation: NorthShore University HealthSystem
  investigator full name: Matthew Derrick
  investigator title: Attending Neonatologist
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Premature Birth
  mesh term: Poractant alfa
  sharing ipd: No