xml: <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/NCT06026163</url>
    </required_header>
    <id_info>
      <org_study_id>H-09-M-11</org_study_id>
      <nct_id>NCT06026163</nct_id>
    </id_info>
    <brief_title>Caffeine as an Adjuvant Therapy for Late Preterm Infants With Respiratory Distress</brief_title>
    <acronym>CAT/LPT</acronym>
    <official_title>Caffeine for Late Preterm Infants: A Double Blind Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ministry of Health, Saudi Arabia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ministry of Health, Saudi Arabia</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        Use of caffeine citrate in late-preterm infants with respiratory distress is questionable.&#xD;
        Oliphant and colleagues found in a recently published study that caffeine therapy use in&#xD;
        late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20&#xD;
        mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.&#xD;
  &#xD;
        The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea,&#xD;
        shorten the hospital stay and improve arousal state in late preterm infants.&#xD;
  &#xD;
        The investigators aim to study the effect of caffeine citrate on late preterm babies as&#xD;
        regard duration of respiratory support, duration of hospital stay, respiratory morbidity,&#xD;
        incidence and frequency of apnea.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        late preterm infants will be randomized in a blinded manner to receive either caffeine in&#xD;
        loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10&#xD;
        mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent&#xD;
        volume of saline in the placebo group. Caffeine will be continued until infants get off all&#xD;
        forms of respiratory support.&#xD;
  &#xD;
        Preparation of caffeine and placebo will be performed by a designated pharmacist who is not&#xD;
        part of the study. Parents and investigators will be remained blinded to the administered&#xD;
        medications throughout the study period.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">March 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2025</primary_completion_date>
    <phase>Phase 2/Phase 3</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>
      <masking_description>Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Duration of respiratory support</measure>
      <time_frame>28 days</time_frame>
      <description>cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Episodes of apnea</measure>
      <time_frame>28 gays</time_frame>
      <description>the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Failure of extubation</measure>
      <time_frame>28 days</time_frame>
      <description>need of re-intubation within 72 h of extubation from mechanical ventilation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of caffeine</measure>
      <time_frame>28 days</time_frame>
      <description>Days of caffeine treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>28 days</time_frame>
      <description>days of hospital admission</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time to full enteral and oral feeding</measure>
      <time_frame>28 days</time_frame>
      <description>days to reach full enteral feeds</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Adverse effects of caffeine use</measure>
      <time_frame>28 days</time_frame>
      <description>Tachycardia, irritability, feeding intolerance, hypertension</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Caffeine withhold</measure>
      <time_frame>28 days</time_frame>
      <description>Caffeine withhold for suspected side effects</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Weight gain per day</measure>
      <time_frame>28 days</time_frame>
      <description>Weight gain per day (gram)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mortality</measure>
      <time_frame>28 days</time_frame>
      <description>Death before hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Readmission rate</measure>
      <time_frame>28 days</time_frame>
      <description>Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Days of apnea</measure>
      <time_frame>28 days</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">134</enrollment>
    <condition>Prematurity</condition>
    <condition>Respiratory Disease</condition>
    <condition>Ventilator Lung; Newborn</condition>
    <arm_group>
      <arm_group_label>Caffeine citrate group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Infants receive either caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Infants received equivalent volume of saline.</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Caffeine citrate</intervention_name>
      <description>Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)</description>
      <arm_group_label>Caffeine citrate group</arm_group_label>
      <other_name>Intervention group</other_name>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>Equivalent volume of saline</description>
      <arm_group_label>Control group</arm_group_label>
      <other_name>Saline</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Newborn infants at gestational age 34 0/7 through 36 6/7&#xD;
  &#xD;
            -  Presented with respiratory distress&#xD;
  &#xD;
            -  Require respiratory support in the form of any of the following :&#xD;
  &#xD;
          A) Invasive mechanical ventilation, B) Non-invasive positive pressure ventilation, C) Nasal&#xD;
          cannula with FIO2 requirement over 50% to keep pre-ductal saturation between 90-95%.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          1 - Late preterm admitted for non-respiratory etiologies 2- Late preterm infants requiring&#xD;
          nasal cannula on less than 50% FIO2 by 4 hours of age as they are less likely to require&#xD;
          respiratory support for a long time.&#xD;
  &#xD;
          3- Newborn infants with congenital malformations and chromosomal anomalies. 4- Infants with&#xD;
          echocardiographic evidence of PPHN requiring medical intervention.&#xD;
  &#xD;
          5- Late preterm with history of maternal substance abuse&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>1 Day</minimum_age>
      <maximum_age>3 Days</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nehad Nasef</last_name>
      <role>Principal Investigator</role>
      <affiliation>Neonatology Consultant</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Ohoud Almoualled, Dr</last_name>
      <phone>+966500550679</phone>
      <email>o.doc2or@gmail.com</email>
    </overall_contact>
    <reference>
      <citation>Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18.</citation>
      <PMID>19926098</PMID>
    </reference>
    <reference>
      <citation>Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.</citation>
      <PMID>26628729</PMID>
    </reference>
    <results_reference>
      <citation>Oliphant EA, McKinlay CJ, McNamara D, Cavadino A, Alsweiler JM. Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):106-113. doi: 10.1136/archdischild-2022-324010. Epub 2022 Aug 29.</citation>
      <PMID>36038256</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 27, 2023</study_first_submitted>
    <study_first_submitted_qc>September 3, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 3, 2023</last_update_submitted>
    <last_update_submitted_qc>September 3, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ministry of Health, Saudi Arabia</investigator_affiliation>
      <investigator_full_name>Fatema Sulaiman Alhazmi</investigator_full_name>
      <investigator_title>NICU Director</investigator_title>
    </responsible_party>
    <keyword>caffeine</keyword>
    <keyword>preterm</keyword>
    <keyword>newborn</keyword>
    <keyword>respiratory support</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Tract Diseases</mesh_term>
      <mesh_term>Respiration Disorders</mesh_term>
      <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    </condition_browse>
    <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>Yes</sharing_ipd>
      <ipd_description>Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_time_frame>Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis.&quot;</ipd_time_frame>
      <ipd_access_criteria>Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06026163
  org study id: H-09-M-11
  nct id: NCT06026163
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Use of caffeine citrate in late-preterm infants with respiratory distress is questionable.
        Oliphant and colleagues found in a recently published study that caffeine therapy use in
        late-preterm infants at a loading dose of 20 and 40 mg/kg and maintenance dose of 10 and 20
        mg/kg/day reduces the incidence of intermittent hypoxia events by 61 and 67% respectively.
  
        The investigators hypothesized that caffeine will improve respiratory drive, prevent apnea,
        shorten the hospital stay and improve arousal state in late preterm infants.
  
        The investigators aim to study the effect of caffeine citrate on late preterm babies as
        regard duration of respiratory support, duration of hospital stay, respiratory morbidity,
        incidence and frequency of apnea.
  late preterm infants will be randomized in a blinded manner to receive either caffeine in
        loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10
        mg/kg/day (equivalent for 5 mg/kg caffeine base) in Caffeine treatment group, or equivalent
        volume of saline in the placebo group. Caffeine will be continued until infants get off all
        forms of respiratory support.
  
        Preparation of caffeine and placebo will be performed by a designated pharmacist who is not
        part of the study. Parents and investigators will be remained blinded to the administered
        medications throughout the study period.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  masking description: Preparation of caffeine and placebo will be performed by a designated pharmacist who is not part of the study. Parents and investigators will be remained blinded to the administered medications throughout the study period.
  measure: Duration of respiratory support
  time frame: 28 days
  description: cumulative duration of mechanical ventilation, non-invasive positive pressure ventilation and nasal cannula therapy (days)
  measure: Episodes of apnea
  time frame: 28 gays
  description: the cessation of breathing for more than 20 seconds or cessation of breathing for accompanied by bradycardia or desaturation
  measure: Failure of extubation
  time frame: 28 days
  description: need of re-intubation within 72 h of extubation from mechanical ventilation
  measure: Duration of caffeine
  time frame: 28 days
  description: Days of caffeine treatment
  measure: Length of hospital stay
  time frame: 28 days
  description: days of hospital admission
  measure: Time to full enteral and oral feeding
  time frame: 28 days
  description: days to reach full enteral feeds
  measure: Adverse effects of caffeine use
  time frame: 28 days
  description: Tachycardia, irritability, feeding intolerance, hypertension
  measure: Caffeine withhold
  time frame: 28 days
  description: Caffeine withhold for suspected side effects
  measure: Weight gain per day
  time frame: 28 days
  description: Weight gain per day (gram)
  measure: Mortality
  time frame: 28 days
  description: Death before hospital discharge
  measure: Readmission rate
  time frame: 28 days
  description: Readmission to the hospital with respiratory related symptoms within 48 hours of hospital discharge
  measure: Days of apnea
  time frame: 28 days
  arm group label: Caffeine citrate group
  arm group type: Experimental
  description: Infants receive either caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base).
  arm group label: Control group
  arm group type: Placebo Comparator
  description: Infants received equivalent volume of saline.
  intervention type: Drug
  intervention name: Caffeine citrate
  description: Caffeine citrate in loading dose 20 mg/kg (equivalent for 10 mg/kg caffeine base) and maintenance dose 10 mg/kg/day (equivalent for 5 mg/kg caffeine base)
  arm group label: Caffeine citrate group
  other name: Intervention group
  intervention type: Other
  intervention name: Placebo
  description: Equivalent volume of saline
  arm group label: Control group
  other name: Saline
  criteria: 
  gender: All
  minimum age: 1 Day
  maximum age: 3 Days
  healthy volunteers: No
  last name: Nehad Nasef
  role: Principal Investigator
  affiliation: Neonatology Consultant
  last name: Ohoud Almoualled, Dr
  phone: +966500550679
  email: o.doc2or@gmail.com
  citation: Davis PG, Schmidt B, Roberts RS, Doyle LW, Asztalos E, Haslam R, Sinha S, Tin W; Caffeine for Apnea of Prematurity Trial Group. Caffeine for Apnea of Prematurity trial: benefits may vary in subgroups. J Pediatr. 2010 Mar;156(3):382-7. doi: 10.1016/j.jpeds.2009.09.069. Epub 2009 Nov 18.
  PMID: 19926098
  citation: Eichenwald EC; Committee on Fetus and Newborn, American Academy of Pediatrics. Apnea of Prematurity. Pediatrics. 2016 Jan;137(1). doi: 10.1542/peds.2015-3757. Epub 2015 Dec 1.
  PMID: 26628729
  citation: Oliphant EA, McKinlay CJ, McNamara D, Cavadino A, Alsweiler JM. Caffeine to prevent intermittent hypoxaemia in late preterm infants: randomised controlled dosage trial. Arch Dis Child Fetal Neonatal Ed. 2023 Mar;108(2):106-113. doi: 10.1136/archdischild-2022-324010. Epub 2022 Aug 29.
  PMID: 36038256
  responsible party type: Principal Investigator
  investigator affiliation: Ministry of Health, Saudi Arabia
  investigator full name: Fatema Sulaiman Alhazmi
  investigator title: NICU Director
  mesh term: Respiratory Tract Diseases
  mesh term: Respiration Disorders
  mesh term: Bronchopulmonary Dysplasia
  mesh term: Caffeine
  mesh term: Caffeine citrate
  sharing ipd: Yes
  ipd description: Data obtained through this study may be provided to qualified researchers for research and scientific purposes (i.e conduction of meta-analysis or systematic review). Data or samples shared will be coded, with no protected health information included. Approval of the request and execution of all applicable agreements (i.e. a material transfer agreement) are prerequisites to the sharing of data with the requesting party.
  ipd info type: Study Protocol
  ipd time frame: Data requests can be submitted starting 3 months after article publication and the data will be made accessible for up to 12 months. Extensions will be considered on a case-by-case basis."
  ipd access criteria: Access to raw data (no protected health information) can be requested by qualified researchers for scientific purposes, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA)