<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/NCT04445571</url>
  </required_header>
  <id_info>
    <org_study_id>180367</org_study_id>
    <nct_id>NCT04445571</nct_id>
  </id_info>
  <brief_title>Surfactant Administration by Insure or Thin Catheter</brief_title>
  <acronym>SAINT</acronym>
  <official_title>Surfactant Administration by Insure or Thin Catheter</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Karolinska Institutet</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>
      This trial evaluates the efficacy and safety of surfactant administration with thin catheter&#xD;
      technique together with analgesic premedication in comparison with the established&#xD;
      INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and&#xD;
      enhance lung protective treatment strategies for preterm infants.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To compare two approaches for surfactant administration during CPAP in preterm infants, the&#xD;
      INSURE and the LISA technique, using premedication intubation protocols, and investigate&#xD;
      aspects of safety, stress and pain, timely administration of the drug, response in&#xD;
      oxygenation and pulmonary outcome.&#xD;
&#xD;
      Our study asks whether (P) among infants born &lt;32 weeks' gestation with RDS (I) does&#xD;
      surfactant administration with LISA and analgesia premedication (C) versus surfactant&#xD;
      administration according to the INSURE protocol (O) improve oxygenation and reduce the rate&#xD;
      of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours&#xD;
      of the procedure&#xD;
&#xD;
      Primary outcomes:&#xD;
&#xD;
        1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24&#xD;
           hours post-procedure.&#xD;
&#xD;
        2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.&#xD;
&#xD;
      Safety outcomes:&#xD;
&#xD;
        1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until&#xD;
           surfactant administration&#xD;
&#xD;
        2. Number of tries before successful intubation/placement of catheter&#xD;
&#xD;
        3. Positive pressure ventilation during the procedure - yes/no/duration (minutes)&#xD;
&#xD;
        4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">May 21, 2021</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">May 31, 2023</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>Randomised controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oxygenation</measure>
    <time_frame>24 hours post-procedure</time_frame>
    <description>Arterial to alveolar ratio (a/A ratio)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mechanical ventilation</measure>
    <time_frame>48 hours post-procedure</time_frame>
    <description>Need for intubation and mechanical ventilation (MV)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of ventilatory support</measure>
    <time_frame>Discharge</time_frame>
    <description>Duration of MV (hours), CPAP (days), Oxygen (days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications</measure>
    <time_frame>Discharge</time_frame>
    <description>Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>Discharge</time_frame>
    <description>Death or composite outcome death/BPD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Discharge</time_frame>
    <description>Number of days in NICU and total in neonatal care, including home care</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Delay time</measure>
    <time_frame>24 hours</time_frame>
    <description>Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration</description>
  </other_outcome>
  <other_outcome>
    <measure>Intubation attempts</measure>
    <time_frame>24 hours</time_frame>
    <description>Number of tries before successful intubation/placement of catheter</description>
  </other_outcome>
  <other_outcome>
    <measure>PPV</measure>
    <time_frame>24 hours</time_frame>
    <description>Positive pressure ventilation during the procedure - yes/no/duration (minutes)</description>
  </other_outcome>
  <other_outcome>
    <measure>Stress and pain</measure>
    <time_frame>24 hours</time_frame>
    <description>Changes in heart rate, blood pressure and BIIP-scales</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">160</enrollment>
  <condition>RDS of Prematurity</condition>
  <condition>Surfactant Deficiency Syndrome Neonatal</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>INSURE</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>LISA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Thin catheter technique or standard ET-tube for surfactant administration</intervention_name>
    <description>Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.</description>
    <arm_group_label>INSURE</arm_group_label>
    <arm_group_label>LISA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born before 32 completed weeks of gestation on CPAP, with clinical and&#xD;
             radiological signs of RDS and need for surfactant treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants requiring surfactant as part of delivery room resuscitation are not eligible.&#xD;
&#xD;
        Infants will be excluded from the final analysis if they have a congenital abnormality or&#xD;
        condition that might have an adverse effect on breathing or ventilation, including:&#xD;
        congenital diaphragmatic hernia; tracheo-oesophageal fistula or cyanotic heart disease.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Kajsa Bohlin, MD</last_name>
    <phone>+46858580000</phone>
    <phone_ext>81356</phone_ext>
    <email>kajsa.bohlin@ki.se</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mats Blennow, MD</last_name>
    <phone>+46858580000</phone>
    <phone_ext>81428</phone_ext>
    <email>mats.blennow@ki.se</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>14186</zip>
        <country>Sweden</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kajsa Bohlin, MD</last_name>
      <phone>0858580000</phone>
      <phone_ext>81356</phone_ext>
      <email>kajsa.bohlin@ki.se</email>
    </contact>
    <contact_backup>
      <last_name>Mats Blennow, MD</last_name>
      <phone>0858580000</phone>
      <phone_ext>81428</phone_ext>
      <email>mats.blennow@ki.se</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>May 23, 2022</last_update_submitted>
  <last_update_submitted_qc>May 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Kajsa Bohlin</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <keyword>LISA (Less invasive surfactant administration)</keyword>
  <keyword>INSURE</keyword>
  <keyword>CPAP</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Surfactants</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/NCT04445571
org study id: 180367
nct id: NCT04445571
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This trial evaluates the efficacy and safety of surfactant administration with thin catheter
      technique together with analgesic premedication in comparison with the established
      INSURE-strategy. It will provide valuable knowledge to improve clinical methodology and
      enhance lung protective treatment strategies for preterm infants.
To compare two approaches for surfactant administration during CPAP in preterm infants, the
      INSURE and the LISA technique, using premedication intubation protocols, and investigate
      aspects of safety, stress and pain, timely administration of the drug, response in
      oxygenation and pulmonary outcome.

      Our study asks whether (P) among infants born <32 weeks' gestation with RDS (I) does
      surfactant administration with LISA and analgesia premedication (C) versus surfactant
      administration according to the INSURE protocol (O) improve oxygenation and reduce the rate
      of respiratory failure and need for intubation and mechanical ventilation (T) within 48 hours
      of the procedure

      Primary outcomes:

        1. Positive effect: Oxygenation measured as arterial to alveolar ratio (a/A ratio) at 24
           hours post-procedure.

        2. Negative effect: Need for mechanical ventilation (MV) within 48 hours post-procedure.

      Safety outcomes:

        1. Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until
           surfactant administration

        2. Number of tries before successful intubation/placement of catheter

        3. Positive pressure ventilation during the procedure - yes/no/duration (minutes)

        4. Stress and pain (changes in heart rate, blood pressure and BIIP-scale)
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Randomised controlled trial
primary purpose: Treatment
masking: None (Open Label)
measure: Oxygenation
time frame: 24 hours post-procedure
description: Arterial to alveolar ratio (a/A ratio)
measure: Mechanical ventilation
time frame: 48 hours post-procedure
description: Need for intubation and mechanical ventilation (MV)
measure: Duration of ventilatory support
time frame: Discharge
description: Duration of MV (hours), CPAP (days), Oxygen (days)
measure: Complications
time frame: Discharge
description: Incidence of air leaks, bronchopulmonary dysplasia, Systemic hypotension, retinopathy, necrotizing entercolitis, intraventricular hemorrhage, persistent duct
measure: Mortality
time frame: Discharge
description: Death or composite outcome death/BPD
measure: Length of stay
time frame: Discharge
description: Number of days in NICU and total in neonatal care, including home care
measure: Delay time
time frame: 24 hours
description: Time from meeting the FiO2 or a/A ratio criteria for surfactant treatment until surfactant administration
measure: Intubation attempts
time frame: 24 hours
description: Number of tries before successful intubation/placement of catheter
measure: PPV
time frame: 24 hours
description: Positive pressure ventilation during the procedure - yes/no/duration (minutes)
measure: Stress and pain
time frame: 24 hours
description: Changes in heart rate, blood pressure and BIIP-scales
arm group label: INSURE
arm group type: Active Comparator
description: Surfactant administration by Intubation-surfactant-extubation to CPAP according to standard protocol including premedication with analgesia and sedation.
arm group label: LISA
arm group type: Active Comparator
description: Surfactant administration by thin catheter during spontaneous breathing and continued CPAP according to set protocol including premedication with analgesia.
intervention type: Procedure
intervention name: Thin catheter technique or standard ET-tube for surfactant administration
description: Surfactant administration by intubation with regular ET-tube followed by immediate extubation to CPAP (INSURE) or by thin catheter during spontaneous breathing and continued CPAP.
arm group label: INSURE
arm group label: LISA
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Days
healthy volunteers: No
last name: Kajsa Bohlin, MD
phone: +46858580000
phone ext: 81356
email: kajsa.bohlin@ki.se
last name: Mats Blennow, MD
phone: +46858580000
phone ext: 81428
email: mats.blennow@ki.se
facility: 
status: Recruiting
contact: 
contact backup: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Kajsa Bohlin
investigator title: MD, PhD
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Distress Syndrome
mesh term: Pulmonary Surfactants
sharing ipd: No