<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/NCT03008200</url>
  </required_header>
  <id_info>
    <org_study_id>KayseriEAH</org_study_id>
    <nct_id>NCT03008200</nct_id>
  </id_info>
  <brief_title>Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)</brief_title>
  <official_title>Fetal Pulmonary Artery Acceleration to Ejection Time Ratio (PATET) in the Prediction of Subsequent Development of Respiratory Distress Syndrome (RDS)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kayseri Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Kayseri Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Fetal PATET ratio evaluation to predict neonatal RDS&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      115 patients were enrolled in this study.Population was recruited from singleton pregnancies&#xD;
      beyond 27 weeks of gestation.All participants underwent a ultrasound examination to measure&#xD;
      fetal pulmonary artery acceleration to ejection time ratio (PATET) by a single experienced&#xD;
      clinician. After the delivery respiratory distress diagnosis made by a pediatrician who were&#xD;
      blinded the doppler waveform measurements.Following the diagnosis, neonates divided into 2&#xD;
      groups as RDS (+) and RDS (-). In addition of RDS diagnosis, neonatal features like 1st and&#xD;
      5th minute APGAR scores, neonatal intensive care unit (NICU) admission and duration in NICU&#xD;
      were also recorded. Afterwards all parameters were statistically analyzed if there is any&#xD;
      significant differences between those two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2015</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome</measure>
    <time_frame>Ten months</time_frame>
    <description>The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">115</enrollment>
  <condition>RDS</condition>
  <arm_group>
    <arm_group_label>RDS +</arm_group_label>
    <description>postpartum RDS developed group</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RDS -</arm_group_label>
    <description>postpartum RDS undeveloped group</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasound examination</intervention_name>
    <description>intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound</description>
    <arm_group_label>RDS +</arm_group_label>
    <arm_group_label>RDS -</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pregnant women beyond 27 weeks&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pregnant women within the 27 weeks of gestation and beyond&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients who did not give birth within 3 days after the ultrasonographic doppler&#xD;
             examination&#xD;
&#xD;
          -  fetuses with Any congenital abnormalities&#xD;
&#xD;
          -  amniotic fluid abnormalities&#xD;
&#xD;
          -  any chronic maternal diseases or pregnancy complications such as;gestational diabetes&#xD;
             mellitus,preeclampsia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Barıs Buke</last_name>
    <role>Principal Investigator</role>
    <affiliation>Kayseri Education and Research Hospital</affiliation>
  </overall_official>
  <reference>
    <citation>Schenone MH, Samson JE, Jenkins L, Suhag A, Mari G. Predicting fetal lung maturity using the fetal pulmonary artery Doppler wave acceleration/ejection time ratio. Fetal Diagn Ther. 2014;36(3):208-14. doi: 10.1159/000358299. Epub 2014 Aug 13.</citation>
    <PMID>25139576</PMID>
  </reference>
  <reference>
    <citation>Azpurua H, Norwitz ER, Campbell KH, Funai EF, Pettker CM, Kleine M, Bahtiyar MO, Malkus H, Copel JA, Thung SF. Acceleration/ejection time ratio in the fetal pulmonary artery predicts fetal lung maturity. Am J Obstet Gynecol. 2010 Jul;203(1):40.e1-8. doi: 10.1016/j.ajog.2010.01.075. Epub 2010 Apr 24.</citation>
    <PMID>20417479</PMID>
  </reference>
  <reference>
    <citation>Guan Y, Li S, Luo G, Wang C, Norwitz ER, Fu Q, Tu X, Tian X, Zhu J. The role of doppler waveforms in the fetal main pulmonary artery in the prediction of neonatal respiratory distress syndrome. J Clin Ultrasound. 2015 Jul-Aug;43(6):375-83. doi: 10.1002/jcu.22219. Epub 2014 Aug 11.</citation>
    <PMID>25110859</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 2, 2017</study_first_posted>
  <last_update_submitted>December 31, 2016</last_update_submitted>
  <last_update_submitted_qc>December 31, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Kayseri Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Emre Destegül</investigator_full_name>
    <investigator_title>Pincipal Investigator</investigator_title>
  </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>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>if necessary</ipd_description>
  </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/NCT03008200
org study id: KayseriEAH
nct id: NCT03008200
lead sponsor: 
has dmc: Yes
Fetal PATET ratio evaluation to predict neonatal RDS
115 patients were enrolled in this study.Population was recruited from singleton pregnancies
      beyond 27 weeks of gestation.All participants underwent a ultrasound examination to measure
      fetal pulmonary artery acceleration to ejection time ratio (PATET) by a single experienced
      clinician. After the delivery respiratory distress diagnosis made by a pediatrician who were
      blinded the doppler waveform measurements.Following the diagnosis, neonates divided into 2
      groups as RDS (+) and RDS (-). In addition of RDS diagnosis, neonatal features like 1st and
      5th minute APGAR scores, neonatal intensive care unit (NICU) admission and duration in NICU
      were also recorded. Afterwards all parameters were statistically analyzed if there is any
      significant differences between those two groups.
observational model: Cohort
time perspective: Prospective
measure: Measurement of fetal pulmonary acceleration time to ejection time ratio via ultrasonography in the 115 pregnant women between 27 to 37 weeks of gestation for prediction of respiratory distress syndrome
time frame: Ten months
description: The aim of this study is to obtain the effectiveness of fetal pulmonary artery acceleration time to ejection time ratio in fetal lung maturity evaluation
arm group label: RDS +
description: postpartum RDS developed group
arm group label: RDS -
description: postpartum RDS undeveloped group
intervention type: Device
intervention name: ultrasound examination
description: intrauterine fetal pulmonary artery acceleration time to ejection time ratio measurement via ultrasound
arm group label: RDS +
arm group label: RDS -
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Barıs Buke
role: Principal Investigator
affiliation: Kayseri Education and Research Hospital
citation: Schenone MH, Samson JE, Jenkins L, Suhag A, Mari G. Predicting fetal lung maturity using the fetal pulmonary artery Doppler wave acceleration/ejection time ratio. Fetal Diagn Ther. 2014;36(3):208-14. doi: 10.1159/000358299. Epub 2014 Aug 13.
PMID: 25139576
citation: Azpurua H, Norwitz ER, Campbell KH, Funai EF, Pettker CM, Kleine M, Bahtiyar MO, Malkus H, Copel JA, Thung SF. Acceleration/ejection time ratio in the fetal pulmonary artery predicts fetal lung maturity. Am J Obstet Gynecol. 2010 Jul;203(1):40.e1-8. doi: 10.1016/j.ajog.2010.01.075. Epub 2010 Apr 24.
PMID: 20417479
citation: Guan Y, Li S, Luo G, Wang C, Norwitz ER, Fu Q, Tu X, Tian X, Zhu J. The role of doppler waveforms in the fetal main pulmonary artery in the prediction of neonatal respiratory distress syndrome. J Clin Ultrasound. 2015 Jul-Aug;43(6):375-83. doi: 10.1002/jcu.22219. Epub 2014 Aug 11.
PMID: 25110859
responsible party type: Principal Investigator
investigator affiliation: Kayseri Education and Research Hospital
investigator full name: Emre Destegül
investigator title: Pincipal Investigator
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
sharing ipd: Yes
ipd description: if necessary