<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/NCT04497740</url>
  </required_header>
  <id_info>
    <org_study_id>GO20529</org_study_id>
    <nct_id>NCT04497740</nct_id>
  </id_info>
  <brief_title>Follow-up Results of Newborns With Tracheostomy</brief_title>
  <acronym>FRONWT</acronym>
  <official_title>Retrospective Evaluation of Follow-up Results of Newborns Who Underwent Tracheostomy</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>
      The chances of survival in premature babies, especially in babies born under 28 weeks, have&#xD;
      increased in recent years, and comorbidities also increase. Bronchopulmonary dysplasia (BPD),&#xD;
      one of the premature problems, is one of them. After a while, babies with heavy BPD are&#xD;
      discharged with the support of a home-type mechanical ventilator by opening a tracheostomy.&#xD;
      Tracheostomy procedure is performed by specialist doctors of otolaryngology under general&#xD;
      anesthesia in the operating room conditions in newborns. Complications of this procedure such&#xD;
      as bleeding, skin necrosis, decanulation, trachea laceration and infection in the early&#xD;
      period can be seen. In the long term, in addition to complications such as formation of&#xD;
      tracheal granulation tissue, ulceration, laceration due to the procedure, babies with&#xD;
      tracheostomy may develop nutrition and speech problems and neurodevelopmental problems.&#xD;
&#xD;
      In the literature, there is no comprehensive clinical follow-up study involving early and&#xD;
      late clinical results related to newborns undergoing tracheostomy. In this study, early and&#xD;
      late follow-up results (indications, anthropometric measurements, mechanical ventilation and&#xD;
      oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure&#xD;
      times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe&#xD;
      University Ihsan Dogramaci Children's Hospital. results, accompanying other comorbidities,&#xD;
      etc.).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      With the advances in science and technology in recent years, the rate of survival of&#xD;
      high-risk newborns has increased in neonatal intensive care units. Some of these babies are&#xD;
      left in the neonatal intensive care unit for a long time, and because of the need for&#xD;
      respiratory support, tracheostomy is opened and discharged with home mechanical ventilator&#xD;
      devices.&#xD;
&#xD;
      Especially babies with severe BPD cannot be extubated and they may be exposed to trauma of&#xD;
      long-term intubation. Subglottic stenosis is the most common result of this trauma. Some of&#xD;
      the babies with severe BPD are discharged by the otolaryngology specialist doctor before&#xD;
      discharge, to prevent both long-term intubation complications, airway obstruction or tracheal&#xD;
      stenosis and adaptation to the home mechanical ventilator.&#xD;
&#xD;
      In addition to babies with BPD, tracheostomy is opened to babies in the early period due to&#xD;
      various developmental tracheal anomalies in our unit. Some of these are congenital tracheal&#xD;
      stenosis, congenital laryngeal atresia, laryngeal web.&#xD;
&#xD;
      In the following process, the growth of the baby, the development of the lungs and auxiliary&#xD;
      respiratory muscles and the need for mechanical ventilator support are eliminated and the&#xD;
      patient can wean from the ventilator support. In addition, the tracheostomy procedure secures&#xD;
      the patient's airway and allows it to be fed easily by mouth and the comfort of the patient.&#xD;
&#xD;
      When the tracheostomy requirement of the patient disappears (mechanical ventilator, when&#xD;
      oxygen is not needed), tracheostomy closure can be performed to ensure the patient has normal&#xD;
      larynx functions (sounding, speech, airway protection reflexes).&#xD;
&#xD;
      In the literature, there is no comprehensive clinical follow-up study involving early and&#xD;
      late clinical results related to newborns undergoing tracheostomy. In this study, early and&#xD;
      late follow-up results (indications, anthropometric measurements, mechanical ventilation and&#xD;
      oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure&#xD;
      times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe&#xD;
      University Ihsan Dogramaci Children's Hospital results, accompanying other comorbidities,&#xD;
      etc.). This study is planned as a retrospective study. Participants planned to determine the&#xD;
      results of the study whether these babies should be careful in the follow-up and to take&#xD;
      precautions in order to lead a better and healthier life, and what participants can do in&#xD;
      order to provide these babies and their families with better health care support.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">August 10, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>follow up after tracheostomy</measure>
    <time_frame>15 years</time_frame>
    <description>Follow-up of patients who have been in our NICU for the last fifteen years and discharged with tracheostomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluation of tracheostomy opening indications</measure>
    <time_frame>15 years</time_frame>
    <description>indications of tracheostomy in the last fifteen years in our unit</description>
  </secondary_outcome>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Premature</condition>
  <condition>Tracheostomy Complication</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        These are the babies who stayed in Hacettepe University Ihsan Dogramaci Children's Hospital&#xD;
        Neonatal Intensive Care Unit between 01.01.2005-31.12.2019, underwent tracheostomy&#xD;
        procedure and followed up at risky neonatal outpatient clinic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  These are the babies who stayed in Hacettepe University Ihsan Dogramaci Children's&#xD;
             Hospital Neonatal Intensive Care Unit between 01.01.2005-31.12.2019, underwent&#xD;
             tracheostomy procedure and followed up at risky neonatal outpatient clinic.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Newborns whose file and follow-up information required for the study are not available&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>15 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hasan T Celik, Ass Prof.</last_name>
    <phone>+905305925584</phone>
    <email>htcelik@gmail.com</email>
  </overall_contact>
  <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/30396419/</url>
    <description>Related Info</description>
  </link>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 4, 2020</study_first_posted>
  <last_update_submitted>August 4, 2020</last_update_submitted>
  <last_update_submitted_qc>August 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 6, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <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 10, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/40/NCT04497740/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/NCT04497740
org study id: GO20529
nct id: NCT04497740
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The chances of survival in premature babies, especially in babies born under 28 weeks, have
      increased in recent years, and comorbidities also increase. Bronchopulmonary dysplasia (BPD),
      one of the premature problems, is one of them. After a while, babies with heavy BPD are
      discharged with the support of a home-type mechanical ventilator by opening a tracheostomy.
      Tracheostomy procedure is performed by specialist doctors of otolaryngology under general
      anesthesia in the operating room conditions in newborns. Complications of this procedure such
      as bleeding, skin necrosis, decanulation, trachea laceration and infection in the early
      period can be seen. In the long term, in addition to complications such as formation of
      tracheal granulation tissue, ulceration, laceration due to the procedure, babies with
      tracheostomy may develop nutrition and speech problems and neurodevelopmental problems.

      In the literature, there is no comprehensive clinical follow-up study involving early and
      late clinical results related to newborns undergoing tracheostomy. In this study, early and
      late follow-up results (indications, anthropometric measurements, mechanical ventilation and
      oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure
      times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe
      University Ihsan Dogramaci Children's Hospital. results, accompanying other comorbidities,
      etc.).
With the advances in science and technology in recent years, the rate of survival of
      high-risk newborns has increased in neonatal intensive care units. Some of these babies are
      left in the neonatal intensive care unit for a long time, and because of the need for
      respiratory support, tracheostomy is opened and discharged with home mechanical ventilator
      devices.

      Especially babies with severe BPD cannot be extubated and they may be exposed to trauma of
      long-term intubation. Subglottic stenosis is the most common result of this trauma. Some of
      the babies with severe BPD are discharged by the otolaryngology specialist doctor before
      discharge, to prevent both long-term intubation complications, airway obstruction or tracheal
      stenosis and adaptation to the home mechanical ventilator.

      In addition to babies with BPD, tracheostomy is opened to babies in the early period due to
      various developmental tracheal anomalies in our unit. Some of these are congenital tracheal
      stenosis, congenital laryngeal atresia, laryngeal web.

      In the following process, the growth of the baby, the development of the lungs and auxiliary
      respiratory muscles and the need for mechanical ventilator support are eliminated and the
      patient can wean from the ventilator support. In addition, the tracheostomy procedure secures
      the patient's airway and allows it to be fed easily by mouth and the comfort of the patient.

      When the tracheostomy requirement of the patient disappears (mechanical ventilator, when
      oxygen is not needed), tracheostomy closure can be performed to ensure the patient has normal
      larynx functions (sounding, speech, airway protection reflexes).

      In the literature, there is no comprehensive clinical follow-up study involving early and
      late clinical results related to newborns undergoing tracheostomy. In this study, early and
      late follow-up results (indications, anthropometric measurements, mechanical ventilation and
      oxygen deposition times, complications, tracheostomy closure times, tracheostomy closure
      times, neurodevelopmental patients in the Neonatal Intensive Care Unit of Hacettepe
      University Ihsan Dogramaci Children's Hospital results, accompanying other comorbidities,
      etc.). This study is planned as a retrospective study. Participants planned to determine the
      results of the study whether these babies should be careful in the follow-up and to take
      precautions in order to lead a better and healthier life, and what participants can do in
      order to provide these babies and their families with better health care support.
observational model: Case-Only
time perspective: Retrospective
measure: follow up after tracheostomy
time frame: 15 years
description: Follow-up of patients who have been in our NICU for the last fifteen years and discharged with tracheostomy.
measure: evaluation of tracheostomy opening indications
time frame: 15 years
description: indications of tracheostomy in the last fifteen years in our unit
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 15 Years
healthy volunteers: No
last name: Hasan T Celik, Ass Prof.
phone: +905305925584
email: htcelik@gmail.com
facility: 
country: Turkey
url: https://pubmed.ncbi.nlm.nih.gov/30396419/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: H. Tolga Çelik
investigator title: associate professor
mesh term: Bronchopulmonary Dysplasia
sharing ipd: No
provided document: 