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/NCT05987800</url>
    </required_header>
    <id_info>
      <org_study_id>NIV study</org_study_id>
      <nct_id>NCT05987800</nct_id>
    </id_info>
    <brief_title>Non-invasive Ventilation in Preterm Infants</brief_title>
    <official_title>Non-invasive Ventilation in Preterm Infants</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Universitair Ziekenhuis Brussel</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Universitair Ziekenhuis Brussel</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 is a prospective, observational cohort study. For the study part on noninvasive neurally&#xD;
        adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants&#xD;
        prospective data collection will be conducted by chart review and by downloading ventilatory&#xD;
        data from the ventilator. A registration of respiratory severity score will be done by a&#xD;
        caregiver during the weaning period. This consists of a visual assessment of the work of&#xD;
        breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part&#xD;
        of the study a titration procedure will be conducted, afterwards serial electrical impedance&#xD;
        tomography and lung and diaphragm ultrasound measurements will be done.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</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>Total duration of respiratory support</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
      <description>Total number of days of invasive and non-invasive respiratory support</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Rate of bronchopulmonary dysplasia (BPD) or death</measure>
      <time_frame>From birth until gestational age of 36 weeks</time_frame>
      <description>Percentage of infants with BPD or death</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Duration of invasive respiratory support (days)</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of non-invasive respiratory support (days)</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Description of mode of non-invasive respiratory support</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
      <description>Use of NIV-NAVA, CPAP, HHHFNC, oxygen therapy</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of surfactant and mode of administration</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Incidence of nosocomial infection</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Use of corticosteroids for the prevention or treatment of BPD</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
      <description>Use of any corticosteroid (systemic or local)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>From birth until study completion, variating between 3 weeks and 3 months</time_frame>
      <description>Days of stay in the neonatal unit</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory severity score (RSS)</measure>
      <time_frame>From start of the weaning phase until respiratory support is stopped, up to 10 weeks</time_frame>
      <description>RSS will be measured during the weaning phase of non-invasive respiratory support</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>NIV-NAVA breakpoint</measure>
      <time_frame>At inclusion (within 24 hours)</time_frame>
      <description>Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Lung ultrasound score</measure>
      <time_frame>At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks</time_frame>
      <description>Lung ultrasound score will be scored at several time points</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Diaphragm ultrasound</measure>
      <time_frame>At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks</time_frame>
      <description>Measurement of diaphragm thickness with ultrasound</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Silent Spaces</measure>
      <time_frame>At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks</time_frame>
      <description>Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tidal volume (TV)</measure>
      <time_frame>At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks</time_frame>
      <description>Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Center of Ventilation (CoV)</measure>
      <time_frame>At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks</time_frame>
      <description>As measured with electrical impedance tomography (EIT)</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">120</enrollment>
    <condition>Premature Birth</condition>
    <condition>Respiratory Distress Syndrome</condition>
    <condition>Ventilator Lung; Newborn</condition>
    <arm_group>
      <arm_group_label>Preterm infants on non-invasive respiratory support</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>All infants on non-invasive respiratory support will be studied. Only infants on NIV-NAVA, will undergo an intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Titration procedure</intervention_name>
      <description>The NAVA level will be reduced to 0,5 cmH2O/microvolt (µV) for 3 minutes as a starting point. Limit peak pressure will be set to 35 cmH2O (the maxi-mum pressure that can be delivered to the patient is cut off at 30 cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated.&#xD;
  Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 2,5 cmH2O/µV.</description>
      <arm_group_label>Preterm infants on non-invasive respiratory support</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Electrical impedance tomography</intervention_name>
      <description>This is a non-invasive technique consisting of the application of a non-adhesive single-use patient belt to monitor regional changes in lung aeration at the bedside.</description>
      <arm_group_label>Preterm infants on non-invasive respiratory support</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Lung and diaphragm ultrasound</intervention_name>
      <description>Lung ultrasound is a non-invasive technique used to diagnose lung pathology and to monitor lung condition. This technique is part of the standard of care for preterm infants in our neonatal unit. Lung ultrasound scores are calculated at each time an ultrasound is performed.&#xD;
  Ultrasound of the diaphragm consists of a short additional measurement of diaphragm thickness and thickening fraction and will be done at the same time of the lung ultrasound following a standardized procedure.</description>
      <arm_group_label>Preterm infants on non-invasive respiratory support</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Preterm infants (&lt; 37 weeks GA) supported with non-invasive respiratory support.&#xD;
               Non-invasive respiratory support can consist of non-invasive NAVA, nasal continuous&#xD;
               positive airway pressure (nCPAP) or high flow nasal canula (flow &gt; 2 liters/min).The&#xD;
               support can be given as primary respiratory support or as respiratory support after&#xD;
               weaning from invasive ventilation (= after extubation).&#xD;
  &#xD;
            -  Infants can only be enrolled after written and signed informed consent by the parents.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Infant born after a gestational age of 37 weeks or more.&#xD;
  &#xD;
            -  Infants with major congenital malformations or chromosomal abnormalities (eg trisomy&#xD;
               18, congenital diaphragmatic hernia…)&#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>Julie Lefevere, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Universitair Ziekenhuis Brussel</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Filip Cools, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Universitair Ziekenhuis Brussel</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Brenda Van Delft, Nurse</last_name>
      <role>Study Chair</role>
      <affiliation>Universitair Ziekenhuis Brussel</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Caitlin Jansen, Student</last_name>
      <role>Study Chair</role>
      <affiliation>Vrije Universiteit Brussel</affiliation>
    </overall_official>
    <overall_official>
      <last_name>Lissa De Potter, MD</last_name>
      <role>Study Chair</role>
      <affiliation>Universitair Ziekenhuis Brussel</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Julie Lefevere, MD</last_name>
      <phone>024777721</phone>
      <email>julie.lefevere@uzbrussel.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Brenda Van Delft</last_name>
      <email>brenda.vandelft@uzbrussel.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Universitair Ziekenhuis Brussel</name>
        <address>
          <city>Jette</city>
          <state>Brussel</state>
          <zip>1090</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Julie Lefevere, MD</last_name>
        <email>julie.lefevere@uzbrussel.be</email>
      </contact>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <reference>
      <citation>Baraldi E, Filippone M. Chronic lung disease after premature birth. N Engl J Med. 2007 Nov 8;357(19):1946-55. doi: 10.1056/NEJMra067279. No abstract available.</citation>
      <PMID>17989387</PMID>
    </reference>
    <reference>
      <citation>Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.</citation>
      <PMID>30974433</PMID>
    </reference>
    <reference>
      <citation>Lefevere J, Van Delft B, Vervoort M, Cools W, Cools F. Non-invasive neurally adjusted ventilatory assist in preterm infants with RDS: effect of changing NAVA levels. Eur J Pediatr. 2022 Feb;181(2):701-707. doi: 10.1007/s00431-021-04244-3. Epub 2021 Sep 17.</citation>
      <PMID>34533644</PMID>
    </reference>
    <reference>
      <citation>Harada E, Kinoshita M, Iwata S, Saikusa M, Tsuda K, Shindou R, Sahashi T, Kato S, Yamada Y, Saitoh S, Iwata O. Visual function scale for identification of infants with low respiratory compliance. Pediatr Neonatol. 2019 Dec;60(6):611-616. doi: 10.1016/j.pedneo.2019.02.006. Epub 2019 Mar 2.</citation>
      <PMID>30905442</PMID>
    </reference>
    <reference>
      <citation>Thomson J, Ruegger CM, Perkins EJ, Pereira-Fantini PM, Farrell O, Owen LS, Tingay DG. Regional ventilation characteristics during non-invasive respiratory support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):370-375. doi: 10.1136/archdischild-2020-320449. Epub 2020 Nov 27.</citation>
      <PMID>33246967</PMID>
    </reference>
    <reference>
      <citation>Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021 Sep;90(3):524-531. doi: 10.1038/s41390-018-0114-9. Epub 2018 Jul 20.</citation>
      <PMID>30127522</PMID>
    </reference>
    <reference>
      <citation>Alonso-Ojembarrena A, Ruiz-Gonzalez E, Estepa-Pedregosa L, Armenteros-Lopez AI, Segado-Arenas A, Lubian-Lopez SP. Reproducibility and reference values of diaphragmatic shortening fraction for term and premature infants. Pediatr Pulmonol. 2020 Aug;55(8):1963-1968. doi: 10.1002/ppul.24866. Epub 2020 Jun 5.</citation>
      <PMID>32458563</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>November 2, 2022</study_first_submitted>
    <study_first_submitted_qc>August 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 3, 2023</last_update_submitted>
    <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Premature Birth</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.</ipd_description>
    </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/NCT05987800
  org study id: NIV study
  nct id: NCT05987800
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a prospective, observational cohort study. For the study part on noninvasive neurally
        adjusted ventilatory assist (NIV-NAVA) the design is interventional. For all participants
        prospective data collection will be conducted by chart review and by downloading ventilatory
        data from the ventilator. A registration of respiratory severity score will be done by a
        caregiver during the weaning period. This consists of a visual assessment of the work of
        breathing every 2 hours. For participants on NIV-NAVA consenting to the interventional part
        of the study a titration procedure will be conducted, afterwards serial electrical impedance
        tomography and lung and diaphragm ultrasound measurements will be done.
  allocation: N/A
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Total duration of respiratory support
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  description: Total number of days of invasive and non-invasive respiratory support
  measure: Rate of bronchopulmonary dysplasia (BPD) or death
  time frame: From birth until gestational age of 36 weeks
  description: Percentage of infants with BPD or death
  measure: Duration of invasive respiratory support (days)
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  measure: Duration of non-invasive respiratory support (days)
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  measure: Description of mode of non-invasive respiratory support
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  description: Use of NIV-NAVA, CPAP, HHHFNC, oxygen therapy
  measure: Use of surfactant and mode of administration
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  measure: Incidence of nosocomial infection
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  measure: Use of corticosteroids for the prevention or treatment of BPD
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  description: Use of any corticosteroid (systemic or local)
  measure: Length of hospital stay
  time frame: From birth until study completion, variating between 3 weeks and 3 months
  description: Days of stay in the neonatal unit
  measure: Respiratory severity score (RSS)
  time frame: From start of the weaning phase until respiratory support is stopped, up to 10 weeks
  description: RSS will be measured during the weaning phase of non-invasive respiratory support
  measure: NIV-NAVA breakpoint
  time frame: At inclusion (within 24 hours)
  description: Definition of the breakpoint for patients of NIV-NAVA after following a prespecified titration protocol
  measure: Lung ultrasound score
  time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
  description: Lung ultrasound score will be scored at several time points
  measure: Diaphragm ultrasound
  time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA, up to 10 weeks
  description: Measurement of diaphragm thickness with ultrasound
  measure: Silent Spaces
  time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
  description: Parts (in % of global lung volume) of the lung that are not ventilated as measured with electrical impedance tomography (EIT)
  measure: Tidal volume (TV)
  time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
  description: Percentage of TV per 'Region of Interest' (ROI) as measured with electrical impedance tomography (EIT)
  measure: Center of Ventilation (CoV)
  time frame: At inclusion, day 3, day 7 and weekly thereafter as long as supported with NIV-NAVA as long as supported with NIV-NAVA, up to 10 weeks
  description: As measured with electrical impedance tomography (EIT)
  arm group label: Preterm infants on non-invasive respiratory support
  arm group type: Other
  description: All infants on non-invasive respiratory support will be studied. Only infants on NIV-NAVA, will undergo an intervention.
  intervention type: Diagnostic Test
  intervention name: Titration procedure
  description: The NAVA level will be reduced to 0,5 cmH2O/microvolt (µV) for 3 minutes as a starting point. Limit peak pressure will be set to 35 cmH2O (the maxi-mum pressure that can be delivered to the patient is cut off at 30 cmH2O). Other ventilator settings will be left unchanged and are as clinically indicated.
  Starting from a NAVA level of 0,5 cmH20/µV the level will be increased by 0,5 cmH2O/µV every 3 minutes until reaching a maximum NAVA level of 2,5 cmH2O/µV.
  arm group label: Preterm infants on non-invasive respiratory support
  intervention type: Diagnostic Test
  intervention name: Electrical impedance tomography
  description: This is a non-invasive technique consisting of the application of a non-adhesive single-use patient belt to monitor regional changes in lung aeration at the bedside.
  arm group label: Preterm infants on non-invasive respiratory support
  intervention type: Diagnostic Test
  intervention name: Lung and diaphragm ultrasound
  description: Lung ultrasound is a non-invasive technique used to diagnose lung pathology and to monitor lung condition. This technique is part of the standard of care for preterm infants in our neonatal unit. Lung ultrasound scores are calculated at each time an ultrasound is performed.
  Ultrasound of the diaphragm consists of a short additional measurement of diaphragm thickness and thickening fraction and will be done at the same time of the lung ultrasound following a standardized procedure.
  arm group label: Preterm infants on non-invasive respiratory support
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Julie Lefevere, MD
  role: Principal Investigator
  affiliation: Universitair Ziekenhuis Brussel
  last name: Filip Cools, PhD
  role: Study Director
  affiliation: Universitair Ziekenhuis Brussel
  last name: Brenda Van Delft, Nurse
  role: Study Chair
  affiliation: Universitair Ziekenhuis Brussel
  last name: Caitlin Jansen, Student
  role: Study Chair
  affiliation: Vrije Universiteit Brussel
  last name: Lissa De Potter, MD
  role: Study Chair
  affiliation: Universitair Ziekenhuis Brussel
  last name: Julie Lefevere, MD
  phone: 024777721
  email: julie.lefevere@uzbrussel.be
  last name: Brenda Van Delft
  email: brenda.vandelft@uzbrussel.be
  facility: 
  status: Recruiting
  contact: 
  country: Belgium
  citation: Baraldi E, Filippone M. Chronic lung disease after premature birth. N Engl J Med. 2007 Nov 8;357(19):1946-55. doi: 10.1056/NEJMra067279. No abstract available.
  PMID: 17989387
  citation: Sweet DG, Carnielli V, Greisen G, Hallman M, Ozek E, Te Pas A, Plavka R, Roehr CC, Saugstad OD, Simeoni U, Speer CP, Vento M, Visser GHA, Halliday HL. European Consensus Guidelines on the Management of Respiratory Distress Syndrome - 2019 Update. Neonatology. 2019;115(4):432-450. doi: 10.1159/000499361. Epub 2019 Apr 11.
  PMID: 30974433
  citation: Lefevere J, Van Delft B, Vervoort M, Cools W, Cools F. Non-invasive neurally adjusted ventilatory assist in preterm infants with RDS: effect of changing NAVA levels. Eur J Pediatr. 2022 Feb;181(2):701-707. doi: 10.1007/s00431-021-04244-3. Epub 2021 Sep 17.
  PMID: 34533644
  citation: Harada E, Kinoshita M, Iwata S, Saikusa M, Tsuda K, Shindou R, Sahashi T, Kato S, Yamada Y, Saitoh S, Iwata O. Visual function scale for identification of infants with low respiratory compliance. Pediatr Neonatol. 2019 Dec;60(6):611-616. doi: 10.1016/j.pedneo.2019.02.006. Epub 2019 Mar 2.
  PMID: 30905442
  citation: Thomson J, Ruegger CM, Perkins EJ, Pereira-Fantini PM, Farrell O, Owen LS, Tingay DG. Regional ventilation characteristics during non-invasive respiratory support in preterm infants. Arch Dis Child Fetal Neonatal Ed. 2021 Jul;106(4):370-375. doi: 10.1136/archdischild-2020-320449. Epub 2020 Nov 27.
  PMID: 33246967
  citation: Raimondi F, Yousef N, Migliaro F, Capasso L, De Luca D. Point-of-care lung ultrasound in neonatology: classification into descriptive and functional applications. Pediatr Res. 2021 Sep;90(3):524-531. doi: 10.1038/s41390-018-0114-9. Epub 2018 Jul 20.
  PMID: 30127522
  citation: Alonso-Ojembarrena A, Ruiz-Gonzalez E, Estepa-Pedregosa L, Armenteros-Lopez AI, Segado-Arenas A, Lubian-Lopez SP. Reproducibility and reference values of diaphragmatic shortening fraction for term and premature infants. Pediatr Pulmonol. 2020 Aug;55(8):1963-1968. doi: 10.1002/ppul.24866. Epub 2020 Jun 5.
  PMID: 32458563
  responsible party type: Sponsor
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Bronchopulmonary Dysplasia
  mesh term: Premature Birth
  sharing ipd: No
  ipd description: Database on non-invasive ventilation has the potential to be shared but no concrete plan for sharing individual patient data is made.