<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/NCT01721629</url>
  </required_header>
  <id_info>
    <org_study_id>AAUH190280</org_study_id>
    <nct_id>NCT01721629</nct_id>
  </id_info>
  <brief_title>Weaning of Nasal Continuous Positive Airway Pressure (CPAP) in Premature Infants</brief_title>
  <official_title>Weaning of Nasal Continuous Positive Airway Pressure in Infants Born With a Gestational Age Under 32 Weeks: a Randomized Controlled Multicenter Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate two different strategies for the withdrawal of CPAP&#xD;
      in preterm infants born before 32 weeks of gestation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">April 28, 2017</completion_date>
  <primary_completion_date type="Actual">April 28, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Weight at a gestational age of 40 weeks</measure>
    <time_frame>Up to 16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Weight at completed withdrawal of nasal CPAP</measure>
    <time_frame>From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of oxygen treatment</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of nasal CPAP therapy</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in the hospital</measure>
    <time_frame>Expected median 54 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Occurence of bronchopulmonary dysplasia</measure>
    <time_frame>Up to 12 weeks</time_frame>
    <description>The occurrence of bronchopulmonary dysplasia is defined as need for oxygen therapy (&gt; 21%) at a gestational age of 36 weeks or treatment with oxygen &gt; 21% for at least 28 days (a day of treatment with oxygen &gt; 21% means that the infant received oxygen &gt; 21% for more than 12 hours that days)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Parental anxiety</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression in parents</measure>
    <time_frame>Up to 6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">380</enrollment>
  <condition>Prematurity</condition>
  <condition>Respiratory Distress Syndrome, Infant</condition>
  <arm_group>
    <arm_group_label>Sudden wean of nasal CPAP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The CPAP is taken off at the morning ward round. If the discontinuation of the CPAP fails according to prespecified failure criteria, CPAP is recommenced and continued for at least 24 hours. Then a new evaluation takes place and if the infant again meets the inclusion criteria another attempt of sudden wean can be undertaken. Infants are considered successfully weaned if they are off CPAP for three days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gradual wean of nasal CPAP pressure</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The reduction of the CPAP pressure begins at the morning ward round and the pressure is reduced in steps with 1 cmH2O maximum once a day. Each time the pressure is to be reduced the infant needs to be evaluated according to the inclusion criteria and only if these are still met, will the pressure be reduced. When a CPAP pressure at 4 cmH2O is reached the infant is treated with this pressure for 24 hours and then the CPAP is discontinued. Infants are considered successfully weaned if they are off CPAP for three days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sudden wean of nasal CPAP</intervention_name>
    <arm_group_label>Sudden wean of nasal CPAP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Gradual wean of nasal CPAP</intervention_name>
    <arm_group_label>Gradual wean of nasal CPAP pressure</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gestational age &lt; 32 weeks at birth&#xD;
&#xD;
          -  Current gestational age &gt; 28+6 weeks&#xD;
&#xD;
          -  Nasal CPAP for &gt; 24 hours&#xD;
&#xD;
          -  Nasal CPAP pressure &lt; 8 cmH2O&#xD;
&#xD;
          -  Oxygen requirement &lt; 30% and not increasing&#xD;
&#xD;
          -  Respiratory rate &lt; 70 per minute&#xD;
&#xD;
          -  Less than 3 episodes of oxygen saturation &lt; 70% or a heart rate &lt; 70 beat per minute&#xD;
             in the preceding 24 hours&#xD;
&#xD;
          -  Tolerates time off CPAP during cares (up to 15 minutes)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Congenital malformations of the heart (except patent ductus arteriosus, atrial septal&#xD;
             defect and patent foramen ovale), lung, and gastrointestinal tract&#xD;
&#xD;
          -  Surgical procedures performed on the gastrointestinal tract&#xD;
&#xD;
          -  Known or suspected to have congenital neuromuscular disease&#xD;
&#xD;
          -  Known or suspected syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christina F Jensen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tine B Henriksen, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Department of Paediatrics, Aarhus University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kirsten Wisborg, Centre Director, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Aarhus University Hospital, Head-Neuro Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Finn Ebbesen, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Department of Paediatrics, Aalborg University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anna S Sørensen, MD, Ph.D.</last_name>
    <role>Study Chair</role>
    <affiliation>The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aalborg University Hospital, Department of Pediatrics</name>
      <address>
        <city>Aalborg</city>
        <state>DK</state>
        <zip>9000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aarhus University Hospital, Department of Pediatrics</name>
      <address>
        <city>Aarhus</city>
        <state>DK</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Herning Hospital, Department of Pediatrics</name>
      <address>
        <city>Herning</city>
        <state>DK</state>
        <zip>7400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Viborg Hospital, Department of Pediatrics</name>
      <address>
        <city>Viborg</city>
        <state>DK</state>
        <zip>8800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Vendsyssel Hospital, Department of Pediatrics</name>
      <address>
        <city>Hjørring</city>
        <zip>9800</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Randers Hospital, Department of Pediatrics</name>
      <address>
        <city>Randers</city>
        <zip>8930</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 6, 2012</study_first_posted>
  <last_update_submitted>April 28, 2017</last_update_submitted>
  <last_update_submitted_qc>April 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Christina Friis Jensen</investigator_full_name>
    <investigator_title>MD, Ph.D. student</investigator_title>
  </responsible_party>
  <keyword>Nasal cpap weaning</keyword>
  <keyword>Premature infants</keyword>
  <keyword>Respiratory distress syndrome</keyword>
  <keyword>Randomized controlled trial</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>Hyaline Membrane Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01721629
org study id: AAUH190280
nct id: NCT01721629
lead sponsor: 
has dmc: Yes
The aim of this study is to investigate two different strategies for the withdrawal of CPAP
      in preterm infants born before 32 weeks of gestation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Weight at a gestational age of 40 weeks
time frame: Up to 16 weeks
measure: Weight at completed withdrawal of nasal CPAP
time frame: From date of birth until the date of complete withdrawal of nasal CPAP. Expected median of 14 days
measure: Duration of oxygen treatment
time frame: Up to 6 months
measure: Duration of nasal CPAP therapy
time frame: Up to 6 months
measure: Length of stay in the hospital
time frame: Expected median 54 days
measure: Occurence of bronchopulmonary dysplasia
time frame: Up to 12 weeks
description: The occurrence of bronchopulmonary dysplasia is defined as need for oxygen therapy (> 21%) at a gestational age of 36 weeks or treatment with oxygen > 21% for at least 28 days (a day of treatment with oxygen > 21% means that the infant received oxygen > 21% for more than 12 hours that days)
measure: Parental anxiety
time frame: Up to 6 months
measure: Depression in parents
time frame: Up to 6 months
arm group label: Sudden wean of nasal CPAP
arm group type: Other
description: The CPAP is taken off at the morning ward round. If the discontinuation of the CPAP fails according to prespecified failure criteria, CPAP is recommenced and continued for at least 24 hours. Then a new evaluation takes place and if the infant again meets the inclusion criteria another attempt of sudden wean can be undertaken. Infants are considered successfully weaned if they are off CPAP for three days.
arm group label: Gradual wean of nasal CPAP pressure
arm group type: Other
description: The reduction of the CPAP pressure begins at the morning ward round and the pressure is reduced in steps with 1 cmH2O maximum once a day. Each time the pressure is to be reduced the infant needs to be evaluated according to the inclusion criteria and only if these are still met, will the pressure be reduced. When a CPAP pressure at 4 cmH2O is reached the infant is treated with this pressure for 24 hours and then the CPAP is discontinued. Infants are considered successfully weaned if they are off CPAP for three days.
intervention type: Procedure
intervention name: Sudden wean of nasal CPAP
arm group label: Sudden wean of nasal CPAP
intervention type: Procedure
intervention name: Gradual wean of nasal CPAP
arm group label: Gradual wean of nasal CPAP pressure
criteria: 
gender: All
minimum age: N/A
maximum age: 6 Months
healthy volunteers: No
last name: Christina F Jensen, MD
role: Principal Investigator
affiliation: The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
last name: Tine B Henriksen, Professor
role: Study Director
affiliation: Department of Paediatrics, Aarhus University Hospital
last name: Kirsten Wisborg, Centre Director, DMSc
role: Study Chair
affiliation: Aarhus University Hospital, Head-Neuro Centre
last name: Finn Ebbesen, Professor
role: Study Chair
affiliation: Department of Paediatrics, Aalborg University Hospital
last name: Anna S Sørensen, MD, Ph.D.
role: Study Chair
affiliation: The Perinatal Epidemiology Research Unit and Department of Paediatrics, Aarhus University Hospital
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Christina Friis Jensen
investigator title: MD, Ph.D. student
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Hyaline Membrane Disease