<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/NCT03298347</url>
  </required_header>
  <id_info>
    <org_study_id>201733</org_study_id>
    <nct_id>NCT03298347</nct_id>
  </id_info>
  <brief_title>Caffeine for Preterm Infants With Apnea of Prematurity(AOP)</brief_title>
  <official_title>Caffeine for Preterm Infants With Apnea of Prematurity(AOP): a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm&#xD;
      infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce&#xD;
      the intubation rate effectively is a challenge for neonatologists.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Less evidences about more dose of caffein used in preterm infants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2017</start_date>
  <completion_date type="Anticipated">October 1, 2018</completion_date>
  <primary_completion_date type="Anticipated">October 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the rate of AOP</measure>
    <time_frame>within 100 days</time_frame>
    <description>AOP appears again in preterm infants</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Caffeine</condition>
  <condition>Apnea of Prematurity</condition>
  <arm_group>
    <arm_group_label>80mg/kg of caffeine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>80mg/kg of caffeine is given to treat AOP.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>20mg/kg of caffeine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20mg/kg of caffeine is given to treat AOP.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>80mg/kg of caffeine</intervention_name>
    <description>80mg/kg of caffeine is given to treat AOP</description>
    <arm_group_label>80mg/kg of caffeine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>20mg/kg of caffeine</intervention_name>
    <description>20mg/kg of caffeine is given to treat AOP</description>
    <arm_group_label>20mg/kg of caffeine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  gestational age less than 32 weeks;&#xD;
&#xD;
          -  appear AOP;&#xD;
&#xD;
          -  parents'consents are obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  major congenital abnormalities;&#xD;
&#xD;
          -  Parents' rejection&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Minute</minimum_age>
    <maximum_age>1 Month</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shi Yuan, MD;PhD</last_name>
    <role>Study Director</role>
    <affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ma Juan, MD</last_name>
    <phone>18680887330</phone>
    <email>416767068@qq.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Shi Yuan, MD;PhD</last_name>
    <phone>13508300283</phone>
    <email>petshi530@vip.163.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400042</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Shi Yuan, PhD,MD</last_name>
      <phone>13508300283</phone>
      <email>petshi530@vip.163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 2, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Daping Hospital and the Research Institute of Surgery of the Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Ma Juan</investigator_full_name>
    <investigator_title>Director</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Apnea</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Caffeine</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/NCT03298347
org study id: 201733
nct id: NCT03298347
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Nowadays,caffein is commonly used for AOP, and it reduces the intubation rate in preterm
      infants. However, intubation is needed in about 20%-50% of partial neonates. How to reduce
      the intubation rate effectively is a challenge for neonatologists.
Less evidences about more dose of caffein used in preterm infants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: the rate of AOP
time frame: within 100 days
description: AOP appears again in preterm infants
arm group label: 80mg/kg of caffeine
arm group type: Experimental
description: 80mg/kg of caffeine is given to treat AOP.
arm group label: 20mg/kg of caffeine
arm group type: Active Comparator
description: 20mg/kg of caffeine is given to treat AOP.
intervention type: Drug
intervention name: 80mg/kg of caffeine
description: 80mg/kg of caffeine is given to treat AOP
arm group label: 80mg/kg of caffeine
intervention type: Drug
intervention name: 20mg/kg of caffeine
description: 20mg/kg of caffeine is given to treat AOP
arm group label: 20mg/kg of caffeine
criteria: 
gender: All
minimum age: 1 Minute
maximum age: 1 Month
healthy volunteers: No
last name: Shi Yuan, MD;PhD
role: Study Director
affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
last name: Ma Juan, MD
phone: 18680887330
email: 416767068@qq.com
last name: Shi Yuan, MD;PhD
phone: 13508300283
email: petshi530@vip.163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Daping Hospital and the Research Institute of Surgery of the Third Military Medical University
investigator full name: Ma Juan
investigator title: Director
mesh term: Apnea
mesh term: Premature Birth
mesh term: Caffeine
sharing ipd: Undecided