<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/NCT03007056</url>
  </required_header>
  <id_info>
    <org_study_id>HIFLO</org_study_id>
    <nct_id>NCT03007056</nct_id>
  </id_info>
  <brief_title>High Flow Nasal Cannula in Preterm Infants</brief_title>
  <acronym>HIFLO</acronym>
  <official_title>Effect of High-flow Nasal Cannula Therapy on Exposure to Nasal Continuous Positive Airway Pressure in Very Preterm Infants</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital de la Croix-Rousse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital de la Croix-Rousse</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,&#xD;
      oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also&#xD;
      evaluated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Nasal continuous positive airway pressure (nCPAP) is widely used in preterm infants as it is&#xD;
      efficient, but it creates an unfavorable environment for preterm infants. Indeed is a primary&#xD;
      source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. High&#xD;
      flow nasal cannula (HFNC) introduced more recently in neonatal care supplies high allowing&#xD;
      for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well&#xD;
      tolerated. HFNC could help to improve the environment of preterm infants by reducing&#xD;
      deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents&#xD;
      and babies. Efficacy of HFNC seems to be similar to other non-invasive respiratory supports&#xD;
      for preventing treatment failure, death and bronchopulmonary dysplasia. The benefits of HFNC&#xD;
      implementation was only slightly analyzed in extremely preterm infants. the place of HFNC is&#xD;
      becoming increasingly important in neonatology and could help to improve the quality of care.&#xD;
      Few HFNC devices are available but their cost of use has not been evaluated in Europe.&#xD;
&#xD;
      HIFLO study aimed to assess the impact of HFNC therapy introduction, on exposure to nCPAP and&#xD;
      on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of&#xD;
      extremely preterm infants. The investigators also aim to evaluate the cost of use of nCPAP&#xD;
      and HFNC using two different devices.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.</measure>
    <time_frame>2 years</time_frame>
    <description>The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of oxygen therapy (expressed in days) in the population of very preterm infants.</measure>
    <time_frame>2 years</time_frame>
    <description>The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay (expressed in days) in the population of very preterm infants.</measure>
    <time_frame>2 years</time_frame>
    <description>The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.</measure>
    <time_frame>2 years</time_frame>
    <description>It will be the same evaluation than in whole population, but in extremely preterm infants borm before 29 weeks gestational age.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.</measure>
    <time_frame>2 years</time_frame>
    <description>Cost analysis will be carried out for the three devices: Infant Flow SiPAP, OptiFlow and Precision Flow, including all consumables. To evaluate the costs these devices will be used as recommended by the manufacturers.The calculated costs will be based on an example of three devices in constant use on a 7-day cycle change of the circuits for the Opti-Flow device, and 30-day cycle change for Precision Flow device. Actual costs will be expressed as price per patient per week.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">207</enrollment>
  <condition>Prematurity; Extreme</condition>
  <arm_group>
    <arm_group_label>Period 1</arm_group_label>
    <description>year 2011 nCPAP</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Period 2</arm_group_label>
    <description>year 2014 nCPAP and high flow nasal cannula</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High flow nasal cannula</intervention_name>
    <description>High flow nasal cannula added to the therapeutic arsenal in neonatal care</description>
    <arm_group_label>Period 2</arm_group_label>
    <other_name>HFNC</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All preterm infants born during year 2011 and year 2014, before 32 weeks of gestational age&#xD;
        (GA) or with a birth weight below 1500 g, hospitalized within the first 48 hours of life in&#xD;
        the tertiary care unit at Croix-Rousse Hospital, Lyon, France and discharged home from the&#xD;
        unit.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Infants born before 32 weeks of gestational age&#xD;
&#xD;
          -  Birth weight below 1500 g&#xD;
&#xD;
          -  Infants hospitalized within the first 48 hours of life&#xD;
&#xD;
          -  Infants discharged home from our unit&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Infants transferred to another unit&#xD;
&#xD;
          -  Infants with a severe malformation&#xD;
&#xD;
          -  Infants requiring surgery&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>6 Months</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>jean-charles picaud, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hopital de la croix rousse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital de la croix rousse</name>
      <address>
        <city>Lyon</city>
        <zip>69004</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>November 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 27, 2016</last_update_submitted>
  <last_update_submitted_qc>December 27, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital de la Croix-Rousse</investigator_affiliation>
    <investigator_full_name>Jean-charles PICAUD, MD, PhD</investigator_full_name>
    <investigator_title>Professor of pediatrics</investigator_title>
  </responsible_party>
  <keyword>high flow nasal cannula</keyword>
  <keyword>nasal continuous positive airway pressure</keyword>
  <keyword>noninvasive ventilatory support</keyword>
  <keyword>newborn developmental care</keyword>
  <keyword>bronchopulmonary dysplasia</keyword>
  <keyword>weaning</keyword>
  <keyword>pain</keyword>
  <keyword>length of stay</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Premature Birth</mesh_term>
  </condition_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/NCT03007056
org study id: HIFLO
nct id: NCT03007056
lead sponsor: 
has dmc: No
The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy,
      oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also
      evaluated.
Nasal continuous positive airway pressure (nCPAP) is widely used in preterm infants as it is
      efficient, but it creates an unfavorable environment for preterm infants. Indeed is a primary
      source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. High
      flow nasal cannula (HFNC) introduced more recently in neonatal care supplies high allowing
      for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well
      tolerated. HFNC could help to improve the environment of preterm infants by reducing
      deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents
      and babies. Efficacy of HFNC seems to be similar to other non-invasive respiratory supports
      for preventing treatment failure, death and bronchopulmonary dysplasia. The benefits of HFNC
      implementation was only slightly analyzed in extremely preterm infants. the place of HFNC is
      becoming increasingly important in neonatology and could help to improve the quality of care.
      Few HFNC devices are available but their cost of use has not been evaluated in Europe.

      HIFLO study aimed to assess the impact of HFNC therapy introduction, on exposure to nCPAP and
      on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of
      extremely preterm infants. The investigators also aim to evaluate the cost of use of nCPAP
      and HFNC using two different devices.
observational model: Cohort
time perspective: Retrospective
measure: Duration of exposure to nCPAP, expressed in days in the population of very preterm infants.
time frame: 2 years
description: The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
measure: Duration of oxygen therapy (expressed in days) in the population of very preterm infants.
time frame: 2 years
description: The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
measure: Duration of hospital stay (expressed in days) in the population of very preterm infants.
time frame: 2 years
description: The study aim to compare two periods, before and after HFNC implementation. During the first period, in 2011, nCPAP (Infant FlowSiPAP) was used as a first-line non-invasive respiratory support. During the second period, in 2014, the use of HFNC support was established as soon as it was possible instead of nCPAP for prevention of apnea, or after extubation, and sometimes in infants with moderate respiratory distress syndrome treated without surfactant. Demographic characteristics, antenatal data, birth characteristics and neonatal morbidities, non-invasive ventilation oxygen administration and HFNC, postnatal steroid therapy, total duration of hospital stay, will be collected from our electronic standardized patient record in which they are prospectively encoded. Simple and multiple linear regression analyses will be used to evaluate the difference of nCPAP therapy duration between Group 1 and Group 2 after adjustment on potential cofactors.
measure: Duration of exposure to nCPAP (expressed in days) in extremely preterm infants.
time frame: 2 years
description: It will be the same evaluation than in whole population, but in extremely preterm infants borm before 29 weeks gestational age.
measure: The cost of use (expressed in Euros) of nCPAP and HFNC using two different devices.
time frame: 2 years
description: Cost analysis will be carried out for the three devices: Infant Flow SiPAP, OptiFlow and Precision Flow, including all consumables. To evaluate the costs these devices will be used as recommended by the manufacturers.The calculated costs will be based on an example of three devices in constant use on a 7-day cycle change of the circuits for the Opti-Flow device, and 30-day cycle change for Precision Flow device. Actual costs will be expressed as price per patient per week.
arm group label: Period 1
description: year 2011 nCPAP
arm group label: Period 2
description: year 2014 nCPAP and high flow nasal cannula
intervention type: Other
intervention name: High flow nasal cannula
description: High flow nasal cannula added to the therapeutic arsenal in neonatal care
arm group label: Period 2
other name: HFNC
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 6 Months
healthy volunteers: No
last name: jean-charles picaud, MD, PhD
role: Principal Investigator
affiliation: Hopital de la croix rousse
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital de la Croix-Rousse
investigator full name: Jean-charles PICAUD, MD, PhD
investigator title: Professor of pediatrics
mesh term: Premature Birth
sharing ipd: No