<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/NCT01722760</url>
  </required_header>
  <id_info>
    <org_study_id>H-4-2012-091</org_study_id>
    <nct_id>NCT01722760</nct_id>
  </id_info>
  <brief_title>Tidal Neonatal NO, Vitamins A and D, and Infant Lung Disease - The AD-ON Study</brief_title>
  <official_title>AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillerod Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Hillerod Hospital, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Children born prematurely are of greater risk of developing chronic lung disease&#xD;
      (Bronchopulmonary Dysplasia).&#xD;
&#xD;
      With an increase in the amount of premature children, we expect an increasing number of&#xD;
      children with BPD.&#xD;
&#xD;
      Today we do not have many ways of predicting or treating this condition, and the children are&#xD;
      usually in hospital for several months after birth. Many are dismissed with home oxygen.&#xD;
      Children with BPD are typically often re-submitted to hospital with respiratory disease the&#xD;
      first couple of years, and some of them have problems throughout childhood and into&#xD;
      adulthood.&#xD;
&#xD;
      Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary&#xD;
      Disease (COPD).&#xD;
&#xD;
      The condition as well as the treatment (steroids), are associated with great risk of adverse&#xD;
      effects as Cerebral Palsy, blindness, deafness and mental retardation.&#xD;
&#xD;
      The investigators wish to find a safe way to identify the children in greater risk of&#xD;
      developing BPD, who could therefore benefit from a more intensive treatment.An early&#xD;
      diagnosis would increase the possibility of predicting the prognosis.&#xD;
&#xD;
      Other studies have proven a connection between both low vitamin A and D and high exhaled&#xD;
      nitrogen oxide (NO) with lung disease.&#xD;
&#xD;
      With this trial the investigators wish to make a reference material for NO and vitamins A and&#xD;
      D in infants admitted to the neonatal department at two hospitals in Denmark, both with and&#xD;
      without treatment with nasal Continuous Positive Airway Pressure.&#xD;
&#xD;
      The investigators furthermore wish to describe an eventual connection between BPD and these&#xD;
      factors by examining a large group of children on 7 specific occasions within the first two&#xD;
      months of life and at a one year follow up.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</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>Tidal exhaled Nitrogen Oxide</measure>
    <time_frame>6-7 measures within the first 2 months of life and at 1 year of age.</time_frame>
    <description>Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made.&#xD;
All children in the study will be measured on 8 occasions including a one year follow up.&#xD;
Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin levels</measure>
    <time_frame>From birth to a one year follow up</time_frame>
    <description>Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.&#xD;
Reference material will be made and association to BPD will be noted.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Bronchopulmonary Dysplasia</measure>
    <time_frame>From premature birth to a one year follow up</time_frame>
    <description>The incidence of BPD and the correlation the the above mentioned biomarkers.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1500</enrollment>
  <condition>Term Delivery With Preterm Labor, Third Trimester</condition>
  <condition>Term Delivery With Preterm Labor, Unspecified Trimester</condition>
  <condition>Bronchopulmonary Dysplasia</condition>
  <arm_group>
    <arm_group_label>Term and preterm infants</arm_group_label>
    <description>Term and preterm infants</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>measurements</intervention_name>
    <arm_group_label>Term and preterm infants</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Air samples for Nitrogen oxide NO. Maternal, cord and neonatal blood samples for vitamins A&#xD;
      and D.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Term and preterm infants admitted to Neonatal Care Unit for reference material as control&#xD;
        group.&#xD;
&#xD;
        Preterm infants admitted to Neonatal Intensive Care Unit developing BPD as study group.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit.&#xD;
        Gestational Age 24-42 weeks.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Children with ciliary dyskinesia, as NO is distinguishable lower in these children.&#xD;
&#xD;
          2. Children who can not cooperate to the examination.&#xD;
&#xD;
          3. Children so dependant on oxygen, that the examination/measurement is not possible.&#xD;
&#xD;
          4. Children with pneumothorax&#xD;
&#xD;
          5. Children having a diagnosed pneumonia verified by tracheal secrete.&#xD;
&#xD;
          6. Children with bigger congenital anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>2 Days</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Birgitte J Schmidt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children´s Dep, North Zealand Hospital Hilleroed, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Neonatal departement GN, Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Region H</state>
        <zip>2200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children´s Departement, North Zealand Hospital, Hilleroed</name>
      <address>
        <city>Hilleroed</city>
        <state>Region H</state>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 6, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>November 5, 2015</last_update_submitted>
  <last_update_submitted_qc>November 5, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 6, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillerod Hospital, Denmark</investigator_affiliation>
    <investigator_full_name>Birgitte Johanne Schmidt</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Neonatal</keyword>
  <keyword>Preterm</keyword>
  <keyword>Bronchopulmonary Dysplasia</keyword>
  <keyword>Nasal Continuous Positive airway Pressure (CPAP)</keyword>
  <keyword>Oxygen</keyword>
  <keyword>Vitamin A</keyword>
  <keyword>Vitamin D</keyword>
  <keyword>Nitrogen oxide (NO)</keyword>
  <keyword>Reference material</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bronchopulmonary Dysplasia</mesh_term>
    <mesh_term>Premature Birth</mesh_term>
    <mesh_term>Obstetric Labor, Premature</mesh_term>
  </condition_browse>
  <!-- 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/NCT01722760
org study id: H-4-2012-091
nct id: NCT01722760
lead sponsor: 
collaborator: 
has dmc: Yes
Children born prematurely are of greater risk of developing chronic lung disease
      (Bronchopulmonary Dysplasia).

      With an increase in the amount of premature children, we expect an increasing number of
      children with BPD.

      Today we do not have many ways of predicting or treating this condition, and the children are
      usually in hospital for several months after birth. Many are dismissed with home oxygen.
      Children with BPD are typically often re-submitted to hospital with respiratory disease the
      first couple of years, and some of them have problems throughout childhood and into
      adulthood.

      Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary
      Disease (COPD).

      The condition as well as the treatment (steroids), are associated with great risk of adverse
      effects as Cerebral Palsy, blindness, deafness and mental retardation.

      The investigators wish to find a safe way to identify the children in greater risk of
      developing BPD, who could therefore benefit from a more intensive treatment.An early
      diagnosis would increase the possibility of predicting the prognosis.

      Other studies have proven a connection between both low vitamin A and D and high exhaled
      nitrogen oxide (NO) with lung disease.

      With this trial the investigators wish to make a reference material for NO and vitamins A and
      D in infants admitted to the neonatal department at two hospitals in Denmark, both with and
      without treatment with nasal Continuous Positive Airway Pressure.

      The investigators furthermore wish to describe an eventual connection between BPD and these
      factors by examining a large group of children on 7 specific occasions within the first two
      months of life and at a one year follow up.
observational model: Cohort
time perspective: Prospective
measure: Tidal exhaled Nitrogen Oxide
time frame: 6-7 measures within the first 2 months of life and at 1 year of age.
description: Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made.
All children in the study will be measured on 8 occasions including a one year follow up.
Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.
measure: Vitamin levels
time frame: From birth to a one year follow up
description: Blood levels of Vitamins A (s-retinol) and D (se-25(OH)D2 and D3) will be measured at 3 preset occasions and at one year follow up, as well as maternal and cord blood at the time of birth.
Reference material will be made and association to BPD will be noted.
measure: Bronchopulmonary Dysplasia
time frame: From premature birth to a one year follow up
description: The incidence of BPD and the correlation the the above mentioned biomarkers.
arm group label: Term and preterm infants
description: Term and preterm infants
intervention type: Procedure
intervention name: measurements
arm group label: Term and preterm infants
Air samples for Nitrogen oxide NO. Maternal, cord and neonatal blood samples for vitamins A
      and D.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 2 Days
healthy volunteers: Accepts Healthy Volunteers
last name: Birgitte J Schmidt, MD
role: Principal Investigator
affiliation: Children´s Dep, North Zealand Hospital Hilleroed, Denmark
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hillerod Hospital, Denmark
investigator full name: Birgitte Johanne Schmidt
investigator title: MD
mesh term: Bronchopulmonary Dysplasia
mesh term: Premature Birth
mesh term: Obstetric Labor, Premature