<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/NCT04483492</url>
  </required_header>
  <id_info>
    <org_study_id>KA-20029</org_study_id>
    <nct_id>NCT04483492</nct_id>
  </id_info>
  <brief_title>Direct Effect of Caffeine on Diaphragmatic Muscles</brief_title>
  <official_title>Direct Effect of Caffeine on Diaphragmatic Muscles</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2&#xD;
      in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility&#xD;
      has also been found in experimental studies. A study of premature newborns has showed&#xD;
      caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about&#xD;
      caffeine direct effect on diaphragma.&#xD;
&#xD;
      Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic&#xD;
      contractility.&#xD;
&#xD;
      Method: The babies under 32 weeks with respiratory support, are being enrolled in this study&#xD;
      if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made&#xD;
      by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of&#xD;
      diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior&#xD;
      subcostal view. The velocity before and after caffeine administration will be calculated,&#xD;
      dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at&#xD;
      inspiratory and expiratory phases are also observed on M mode and the difference between the&#xD;
      two phases are measured.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 1, 2019</start_date>
  <completion_date type="Anticipated">December 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2020</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>diphragmatic contractility</measure>
    <time_frame>30 minutes</time_frame>
    <description>diphragmatic contractility measured by ultrasonographic evaluation</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">56</enrollment>
  <condition>Caffeine</condition>
  <arm_group>
    <arm_group_label>1</arm_group_label>
    <description>newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Caffeine citrate</intervention_name>
    <description>diaphragm contractility after administration</description>
    <arm_group_label>1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        newborns under 32 weeks with respiratory support on their first week&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  newborns under 32 weeks with respiratory support&#xD;
&#xD;
          -  caffeine is decided to give&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  babies with congenital malformations&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Day</minimum_age>
    <maximum_age>7 Days</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Hasan Tolga Celik, MD</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>
    <status>Recruiting</status>
    <contact>
      <last_name>Hasan Tolga Celik, MD</last_name>
      <phone>+905305925584</phone>
      <email>htcelik@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.</citation>
    <PMID>25982138</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>July 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>July 20, 2020</last_update_submitted>
  <last_update_submitted_qc>July 20, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 23, 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>Principal Investigator</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</mesh_term>
    <mesh_term>Caffeine citrate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04483492
org study id: KA-20029
nct id: NCT04483492
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
The mechanism of methylxanthines is thought to increase chemoreceptor responsiveness to CO2
      in central nervous system. Besides, effect of methylxanthines on diaphragmatic contractility
      has also been found in experimental studies. A study of premature newborns has showed
      caffeine increase diaphragmatic activity and tidal volume. But, there is limited data about
      caffeine direct effect on diaphragma.

      Objective: The investigators aimed to show the direct effect of caffeine on diphragmatic
      contractility.

      Method: The babies under 32 weeks with respiratory support, are being enrolled in this study
      if caffeine treatment is decided to receive. Evaluation of muscle contraction is being made
      by ultrasound before and 30 minutes after caffeine loading dose. Right and left sides of
      diaphragm thickness are being measured by two clinicians on B mode ultrasound by anterior
      subcostal view. The velocity before and after caffeine administration will be calculated,
      dividing excursion frequency (parameter) for inspiratory time. Movement of the diaphragm at
      inspiratory and expiratory phases are also observed on M mode and the difference between the
      two phases are measured.
observational model: Cohort
time perspective: Prospective
measure: diphragmatic contractility
time frame: 30 minutes
description: diphragmatic contractility measured by ultrasonographic evaluation
arm group label: 1
description: newborns under 32 weeks with respiratory support if they are decided to start caffeine treatment
intervention type: Drug
intervention name: Caffeine citrate
description: diaphragm contractility after administration
arm group label: 1
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 1 Day
maximum age: 7 Days
healthy volunteers: No
last name: Hasan Tolga Celik, MD
phone: +905305925584
email: htcelik@gmail.com
facility: 
status: Recruiting
contact: 
country: Turkey
citation: Kraaijenga JV, Hutten GJ, de Jongh FH, van Kaam AH. The Effect of Caffeine on Diaphragmatic Activity and Tidal Volume in Preterm Infants. J Pediatr. 2015 Jul;167(1):70-5. doi: 10.1016/j.jpeds.2015.04.040. Epub 2015 May 15.
PMID: 25982138
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: H. Tolga Çelik
investigator title: Principal Investigator
mesh term: Caffeine
mesh term: Caffeine citrate
sharing ipd: Undecided