<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/NCT04505176</url>
  </required_header>
  <id_info>
    <org_study_id>KA-19071</org_study_id>
    <nct_id>NCT04505176</nct_id>
  </id_info>
  <brief_title>Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent MIST Under HHHFNC or Nasal CPAP Methods</brief_title>
  <acronym>TCOPHC</acronym>
  <official_title>Comparison of the Results of Transcutaneous Carbon Dioxide and Oxygen Pressure in Premature Neonates Who Underwent Minimally Invasive Surfactant Therapy (MIST) Under Heated Respiratory Support With Nasal Cannula High Flow Air Support (HHHFNC) or Nasal Continuous Airway Pressure (CPAP) Methods</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</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>
      Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS)&#xD;
      Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar&#xD;
      methods have been studied with a thin catheter without endotracheal intubation in the&#xD;
      application of surfactant.&#xD;
&#xD;
      In our neonatal intensive care unit, respiratory support is given with nasal CPAP and&#xD;
      Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated)&#xD;
      mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain&#xD;
      pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain&#xD;
      flow rate (6-8 L / min). This study was planned to compare the results of infants who were&#xD;
      given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or&#xD;
      HHHFNC support in the treatment of respiratory distress syndrome in premature babies.&#xD;
&#xD;
      During surfactant application, babies will be monitored (as in all babies in the NICU)&#xD;
      saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary&#xD;
      bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion&#xD;
      Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2&#xD;
      values are of great importance for the prevention of mortality and morbidity, as well as&#xD;
      monitoring of oxygen saturation values with pulse oximetry in premature babies.&#xD;
&#xD;
      In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less&#xD;
      than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients&#xD;
      will be consecutively distributed to two groups until they reach the specified number of&#xD;
      patients.&#xD;
&#xD;
      In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous&#xD;
      PO2 and PCO2 measurements just before, during and after the surfactant application and to&#xD;
      compare the results of babies who received nCPAP and HHHFNC support.&#xD;
&#xD;
      At the end of the study, all data will be entered in an SPSS (Statistical Package for the&#xD;
      Social Sciences) file and study statistics will be made. A database will be created using&#xD;
      SPSS software. A p value of &lt;0.05 was determined as the limit of significance.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In premature babies (born before 37th week of pregnancy), surfactant production is&#xD;
      insufficient since lung maturation has not been completed yet. Accordingly, surface tension&#xD;
      increases in alveoli and it is difficult to keep the alveoli open, gas exchange is&#xD;
      insufficient, and as a result, respiratory distress syndrome (RDS) occurs in premature&#xD;
      babies. Severe respiratory failure occurs in the baby, it must be connected to the mechanical&#xD;
      ventilator, even if hypoxia cannot be corrected, the baby may be lost. Intratracheal&#xD;
      surfactant treatment is applied in the treatment of respiratory distress syndrome, which&#xD;
      develops due to surfactant deficiency. With surfactant treatment, death due to RDS,&#xD;
      mechanical ventilation requirement, morbidity due to lung disease, hospitalization times in&#xD;
      neonatal intensive care units have been reduced and survival rates of premature babies have&#xD;
      increased.&#xD;
&#xD;
      Intraracheal surfactant treatment is applied in RDS treatment. In recent clinical studies,&#xD;
      two similar methods have been studied with a thin catheter without endotracheal intubation in&#xD;
      the application of surfactant. One of these methods; Developed in Germany, it is LISA (the&#xD;
      application of surfactant, which is less invasive), which is currently widely used in Europe.&#xD;
      In the LISA(Less invasive surfactant administration) method, surfactant is given after&#xD;
      placing a thin flexible catheter into the trachea with the help of a laryngoscope (Magill's&#xD;
      forceps may or may not be used) while the baby is in CPAP. The second method is the&#xD;
      application of surfactant, which was developed in Australia and given by using a hard thin&#xD;
      vascular catheter into the trachea while the baby is being followed up in CPAP only under&#xD;
      direct laryngoscope without using forceps. This method is called MIST (minimally invasive&#xD;
      surfactant treatment). In both methods, the aim is to give the surfactant warmed up to body&#xD;
      temperature slowly in a few minutes with the help of an injector in a baby with spontaneous&#xD;
      breathing under CPAP.&#xD;
&#xD;
      In the current RDS review (2019), it was emphasized that noninvasive respiratory support is&#xD;
      the most appropriate way to support the breathing of preterm infants. Non invasive methods;&#xD;
      CPAP is specified as bi-level CPAP, HHHFNC, positive pressure ventilation with nasal&#xD;
      interval. CPAP devices provide gas flow under controlled pressure with probes firmly placed&#xD;
      in the nose. Through the distension pressure; Supporting the opening of the upper airway,&#xD;
      continued lung expansion and prevention of end-expiratory alveolar collapse (lung closure at&#xD;
      the end of breath). Thus, it is easier to release the endogenous surfactant.&#xD;
&#xD;
      Heated high flow air support (HHHFNC) moistened with nasal cannula; It has been used as an&#xD;
      alternative to nasal CPAP since 2013 RDS guideline. The utility mechanism allows the removal&#xD;
      of carbon dioxide in the nasopharyngeal area, provides the anatomical dead space to be washed&#xD;
      with air flow, reduces the disadvantage of the anatomical dead space. It also provides&#xD;
      CPAP-like support thanks to its high flow rates. It reduces breathing work. It helps to&#xD;
      reduce the FiO2 level, typically using a flow rate of 4-8 L / min.&#xD;
&#xD;
      According to the RDS review updated in 2019, early surfactant should be applied in infants&#xD;
      with RDS. According to the latest recommendation, surfactant should be given if the baby's&#xD;
      FiO2 (fraction of inspired oxygen) need is over 30%.&#xD;
&#xD;
      In our neonatal intensive care unit, respiratory support is given with nasal CPAP and HHHFNC&#xD;
      instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method,&#xD;
      heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method,&#xD;
      heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned&#xD;
      to compare the results of infants who were given surfactant with MIST method under CPAP or&#xD;
      HHHFNC support in the treatment of respiratory distress syndrome in premature babies. No&#xD;
      blood will be collected from the babies included in this study, and nothing that will not be&#xD;
      applied to babies who are not included in the study. If these babies need surfactant&#xD;
      according to the chest X-ray and oxygen demand in the breathing air, surfactant support will&#xD;
      be given by MIST method. In the follow-up of these babies, after the surfactant application,&#xD;
      the follow-up application for each baby will be carried out; Blood gas will be taken in the&#xD;
      second and sixth hour, and a chest radiograph will be taken in the sixth hour. The mechanical&#xD;
      ventilation settings of the patient are made according to the values here. For example, the&#xD;
      pressure given in case of insufficient oxygenation, the amount of oxygen is increased, the&#xD;
      pressure given in case of hypercarbia is increased, the pressure is decreased in case of&#xD;
      hypocarbia.&#xD;
&#xD;
      This measurement shows only partial carbon dioxide (PCO2) and partial oxygen (PO2) pressures&#xD;
      in that instant blood gas. It is of great importance to protect the premature babies being&#xD;
      monitored in the intensive care unit from hypoxia and hypercarbia, as well as the pressure,&#xD;
      volume, oxygen-related trauma and injuries given by iatrogenically invasive or non-invasive&#xD;
      respiratory support. Unnecessarily high supply of oxygen can cause oxygen radical damage and&#xD;
      increase the risk of diseases associated with oxygen radical damage (premature retinopathy,&#xD;
      necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leukomalacia). With&#xD;
      the improvement of lung compliance and recovery of gas after surfactant treatment, carbon&#xD;
      dioxide excretion may accelerate and hypocarbia may develop. Hypocarbia can cause&#xD;
      intraventricular hemorrhage and periventricular leukomalacia in premature babies.&#xD;
&#xD;
      During surfactant application, babies will be monitored (as in all babies in the NICU)&#xD;
      saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary&#xD;
      bed) and t values will be recorded. For all these reasons, monitoring of PI, PVI and&#xD;
      continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of&#xD;
      mortality and morbidity, as well as monitoring of oxygen saturation values with pulse&#xD;
      oximetry in premature babies.&#xD;
&#xD;
      Research Method:&#xD;
&#xD;
      In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less&#xD;
      than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients&#xD;
      will be consecutively distributed to two groups until they reach the specified number of&#xD;
      patients.&#xD;
&#xD;
      In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous&#xD;
      PO2 and PCO2 measurements just before, during and after the surfactant application and to&#xD;
      compare the results of babies who received nCPAP and HHHFNC support.&#xD;
&#xD;
      At the end of the study, all data will be entered in an SPSS file and study statistics will&#xD;
      be made. A database will be created using SPSS software. A p value of &lt;0.05 was determined as&#xD;
      the limit of significance.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 30, 2020</start_date>
  <completion_date type="Anticipated">November 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">November 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Comparison of the Results of Transcutaneous Oxygen Pressure</measure>
    <time_frame>12 months</time_frame>
    <description>In this study, it was aimed to monitor continuous transcutaneous PO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Comparison of the Results of Transcutaneous Carbon dioxide Pressure</measure>
    <time_frame>12months</time_frame>
    <description>In this study, it was aimed to monitor continuous transcutaneous PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison of the Results of Saturation Values</measure>
    <time_frame>12 months</time_frame>
    <description>In this study, it was aimed to monitor saturation measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Premature Birth</condition>
  <condition>Respiratory Distress Syndrome</condition>
  <condition>Surfactant Deficiency Syndrome Neonatal</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>20 patients being in the HHHNFC. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2</arm_group_label>
    <description>20 patients in the CPAP group. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        it was planned to take a total of 40 patients born under 32 weeks and less than 1500 grams&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Premature babies under 37 weeks of sleep at Hacettepe University Neonatal Intensive&#xD;
             Care Unit,&#xD;
&#xD;
          -  Infants who have been diagnosed with respiratory distress syndrome in the first 24&#xD;
             hours of life, who have received surfactant treatment under the nCPAP or HHHFNC method&#xD;
             using the MIST method,&#xD;
&#xD;
          -  Babies whose informed consent was obtained from their mothers and / or fathers&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Term babies born 37 weeks and over&#xD;
&#xD;
          -  Babies monitored for intubation due to severe respiratory failure&#xD;
&#xD;
          -  Babies with hemodynamically unstable, severe hypotension&#xD;
&#xD;
          -  Major congenital anomalies (severe congenital heart disease, congenital diaphragmatic&#xD;
             hernia etc.)&#xD;
&#xD;
          -  Babies with chromosomal disorders&#xD;
&#xD;
          -  Babies with hereditary metabolic disease&#xD;
&#xD;
          -  Babies whose informed consent form could not be obtained from their mothers and / or&#xD;
             fathers&#xD;
&#xD;
          -  Babies whose mothers have early membrane rupture or chorioamnionitis&#xD;
&#xD;
          -  Diabetic mother babies&#xD;
&#xD;
          -  Families who want their children to leave the work at any time of the study&#xD;
&#xD;
          -  Babies whose study data cannot be collected completely&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>28 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hacettepe University</name>
      <address>
        <city>Ankara</city>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/25039700/</url>
    <description>HHHFNC- premature infant</description>
  </link>
  <link>
    <url>https://pubmed.ncbi.nlm.nih.gov/23610207/</url>
    <description>nCPAP vs HHHFNC</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 1, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 5, 2020</last_update_submitted>
  <last_update_submitted_qc>August 5, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>H. Tolga Çelik</investigator_full_name>
    <investigator_title>associate professor</investigator_title>
  </responsible_party>
  <keyword>surfactant therapy</keyword>
  <keyword>prematurity</keyword>
  <keyword>transcutaneous measurement</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>
    <mesh_term>Syndrome</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 20, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/76/NCT04505176/Prot_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT04505176
org study id: KA-19071
nct id: NCT04505176
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Intratracheal surfactant treatment is applied in Respiratory Distress Syndrome (RDS)
      Continious Positive Airway Pressure(CPAP) treatment. In recent clinical studies, two similar
      methods have been studied with a thin catheter without endotracheal intubation in the
      application of surfactant.

      In our neonatal intensive care unit, respiratory support is given with nasal CPAP and
      Humidified Heated High Flow Nasal Cannula (HHHFNC) instead of classical invasive (intubated)
      mechanical ventilation methods. In CPAP method, heated and humidified air is given a certain
      pressure (6-8 cmH2O), while in HHHFNC method, heated humidified air is given at a certain
      flow rate (6-8 L / min). This study was planned to compare the results of infants who were
      given surfactant with MIST (Minimal Invazive Surfactant Treatment) method under CPAP or
      HHHFNC support in the treatment of respiratory distress syndrome in premature babies.

      During surfactant application, babies will be monitored (as in all babies in the NICU)
      saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary
      bed) and t values will be recorded. For all these reasons, monitoring of PI (Perfusion
      Index), PVI (plethysmographic variability index) and continuous transcutaneous PCO2 and PO2
      values are of great importance for the prevention of mortality and morbidity, as well as
      monitoring of oxygen saturation values with pulse oximetry in premature babies.

      In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less
      than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients
      will be consecutively distributed to two groups until they reach the specified number of
      patients.

      In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous
      PO2 and PCO2 measurements just before, during and after the surfactant application and to
      compare the results of babies who received nCPAP and HHHFNC support.

      At the end of the study, all data will be entered in an SPSS (Statistical Package for the
      Social Sciences) file and study statistics will be made. A database will be created using
      SPSS software. A p value of <0.05 was determined as the limit of significance.
In premature babies (born before 37th week of pregnancy), surfactant production is
      insufficient since lung maturation has not been completed yet. Accordingly, surface tension
      increases in alveoli and it is difficult to keep the alveoli open, gas exchange is
      insufficient, and as a result, respiratory distress syndrome (RDS) occurs in premature
      babies. Severe respiratory failure occurs in the baby, it must be connected to the mechanical
      ventilator, even if hypoxia cannot be corrected, the baby may be lost. Intratracheal
      surfactant treatment is applied in the treatment of respiratory distress syndrome, which
      develops due to surfactant deficiency. With surfactant treatment, death due to RDS,
      mechanical ventilation requirement, morbidity due to lung disease, hospitalization times in
      neonatal intensive care units have been reduced and survival rates of premature babies have
      increased.

      Intraracheal surfactant treatment is applied in RDS treatment. In recent clinical studies,
      two similar methods have been studied with a thin catheter without endotracheal intubation in
      the application of surfactant. One of these methods; Developed in Germany, it is LISA (the
      application of surfactant, which is less invasive), which is currently widely used in Europe.
      In the LISA(Less invasive surfactant administration) method, surfactant is given after
      placing a thin flexible catheter into the trachea with the help of a laryngoscope (Magill's
      forceps may or may not be used) while the baby is in CPAP. The second method is the
      application of surfactant, which was developed in Australia and given by using a hard thin
      vascular catheter into the trachea while the baby is being followed up in CPAP only under
      direct laryngoscope without using forceps. This method is called MIST (minimally invasive
      surfactant treatment). In both methods, the aim is to give the surfactant warmed up to body
      temperature slowly in a few minutes with the help of an injector in a baby with spontaneous
      breathing under CPAP.

      In the current RDS review (2019), it was emphasized that noninvasive respiratory support is
      the most appropriate way to support the breathing of preterm infants. Non invasive methods;
      CPAP is specified as bi-level CPAP, HHHFNC, positive pressure ventilation with nasal
      interval. CPAP devices provide gas flow under controlled pressure with probes firmly placed
      in the nose. Through the distension pressure; Supporting the opening of the upper airway,
      continued lung expansion and prevention of end-expiratory alveolar collapse (lung closure at
      the end of breath). Thus, it is easier to release the endogenous surfactant.

      Heated high flow air support (HHHFNC) moistened with nasal cannula; It has been used as an
      alternative to nasal CPAP since 2013 RDS guideline. The utility mechanism allows the removal
      of carbon dioxide in the nasopharyngeal area, provides the anatomical dead space to be washed
      with air flow, reduces the disadvantage of the anatomical dead space. It also provides
      CPAP-like support thanks to its high flow rates. It reduces breathing work. It helps to
      reduce the FiO2 level, typically using a flow rate of 4-8 L / min.

      According to the RDS review updated in 2019, early surfactant should be applied in infants
      with RDS. According to the latest recommendation, surfactant should be given if the baby's
      FiO2 (fraction of inspired oxygen) need is over 30%.

      In our neonatal intensive care unit, respiratory support is given with nasal CPAP and HHHFNC
      instead of classical invasive (intubated) mechanical ventilation methods. In CPAP method,
      heated and humidified air is given a certain pressure (6-8 cmH2O), while in HHHFNC method,
      heated humidified air is given at a certain flow rate (6-8 L / min). This study was planned
      to compare the results of infants who were given surfactant with MIST method under CPAP or
      HHHFNC support in the treatment of respiratory distress syndrome in premature babies. No
      blood will be collected from the babies included in this study, and nothing that will not be
      applied to babies who are not included in the study. If these babies need surfactant
      according to the chest X-ray and oxygen demand in the breathing air, surfactant support will
      be given by MIST method. In the follow-up of these babies, after the surfactant application,
      the follow-up application for each baby will be carried out; Blood gas will be taken in the
      second and sixth hour, and a chest radiograph will be taken in the sixth hour. The mechanical
      ventilation settings of the patient are made according to the values here. For example, the
      pressure given in case of insufficient oxygenation, the amount of oxygen is increased, the
      pressure given in case of hypercarbia is increased, the pressure is decreased in case of
      hypocarbia.

      This measurement shows only partial carbon dioxide (PCO2) and partial oxygen (PO2) pressures
      in that instant blood gas. It is of great importance to protect the premature babies being
      monitored in the intensive care unit from hypoxia and hypercarbia, as well as the pressure,
      volume, oxygen-related trauma and injuries given by iatrogenically invasive or non-invasive
      respiratory support. Unnecessarily high supply of oxygen can cause oxygen radical damage and
      increase the risk of diseases associated with oxygen radical damage (premature retinopathy,
      necrotizing enterocolitis, bronchopulmonary dysplasia, periventricular leukomalacia). With
      the improvement of lung compliance and recovery of gas after surfactant treatment, carbon
      dioxide excretion may accelerate and hypocarbia may develop. Hypocarbia can cause
      intraventricular hemorrhage and periventricular leukomalacia in premature babies.

      During surfactant application, babies will be monitored (as in all babies in the NICU)
      saturation, peak heart rate, perfusion index (the ratio of nonpulsatile flow in the capillary
      bed) and t values will be recorded. For all these reasons, monitoring of PI, PVI and
      continuous transcutaneous PCO2 and PO2 values are of great importance for the prevention of
      mortality and morbidity, as well as monitoring of oxygen saturation values with pulse
      oximetry in premature babies.

      Research Method:

      In our hospital, it was planned to take a total of 40 patients born under 32 weeks and less
      than 1500 grams (20 patients being in the HHHNFC, 20 patients in the CPAP group). Patients
      will be consecutively distributed to two groups until they reach the specified number of
      patients.

      In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous
      PO2 and PCO2 measurements just before, during and after the surfactant application and to
      compare the results of babies who received nCPAP and HHHFNC support.

      At the end of the study, all data will be entered in an SPSS file and study statistics will
      be made. A database will be created using SPSS software. A p value of <0.05 was determined as
      the limit of significance.
observational model: Cohort
time perspective: Prospective
measure: Comparison of the Results of Transcutaneous Oxygen Pressure
time frame: 12 months
description: In this study, it was aimed to monitor continuous transcutaneous PO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
measure: Comparison of the Results of Transcutaneous Carbon dioxide Pressure
time frame: 12months
description: In this study, it was aimed to monitor continuous transcutaneous PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
measure: Comparison of the Results of Saturation Values
time frame: 12 months
description: In this study, it was aimed to monitor saturation measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
arm group label: 1
description: 20 patients being in the HHHNFC. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
arm group label: 2
description: 20 patients in the CPAP group. In this study, it was aimed to monitor continuous oxygen saturation, PI, PVI, transcutaneous PO2 and PCO2 measurements just before, during and after the surfactant application and to compare the results of babies who received nCPAP and HHHFNC support.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 28 Days
healthy volunteers: No
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/25039700/
description: HHHFNC- premature infant
url: https://pubmed.ncbi.nlm.nih.gov/23610207/
description: nCPAP vs HHHFNC
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: H. Tolga Çelik
investigator title: associate professor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Premature Birth
mesh term: Syndrome
provided document: 