<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/NCT03261609</url>
  </required_header>
  <id_info>
    <org_study_id>HAPI clinical project</org_study_id>
    <nct_id>NCT03261609</nct_id>
  </id_info>
  <brief_title>Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.</brief_title>
  <official_title>Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Justine's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Jewish General Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>McGill University Health Centre/Research Institute of the McGill University Health Centre</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>St. Justine's Hospital</source>
  <oversight_info>
    <has_dmc>No</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>
      The purpose of the HAPI project is to study the overall health of preterm infants once they&#xD;
      reach adulthood. The investigators would like to compare the health of adults born preterm&#xD;
      with that of adults born full-term. They would also like to find the early signs, or&#xD;
      biomarkers, of chronic diseases such as high blood pressure, diabetes, osteoporosis, and&#xD;
      chronic lung diseases.&#xD;
&#xD;
      Such biomarkers would allow for early diagnosis and prevention. Furthermore, the&#xD;
      investigators would like to understand why some people born preterm are more likely to&#xD;
      develop chronic disease. They believe that inflammation and oxidative stress may play a part.&#xD;
      Oxidative stress is present when the body is not able to defend itself against oxygen-derived&#xD;
      products that can damage our cells.&#xD;
&#xD;
      To carry out this study, the investigators will examine 6 aspects of the health: (1) heart&#xD;
      and circulation, (2) kidneys, (3) lungs, (4) metabolism - sugars and fats in the blood, (5)&#xD;
      bones, and (6) eyes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The participants, from both groups will spend a whole day at St. Justine's hospital. Upon&#xD;
      arrival after an overnight fast, vital signs and anthropometric measures are taken. Then&#xD;
      blood and urine are obtained as well and a pregnancy test is performed for women. After&#xD;
      inserting a intravenous catheter, around 55 mL of blood is taken and sent to the biochemistry&#xD;
      department and to our laboratory. A oral glucose tolerance test is also performed with blood&#xD;
      sampling over 2hours.&#xD;
&#xD;
      Then a renal and carotid ultrasounds, as well as a osteodensitometry test (bone mineral&#xD;
      density and body muscle/fat composition) are done. Ophtalmology exam is realized by&#xD;
      ophtalmologist, including visual acuity, contrast and fundus photograph, then the&#xD;
      participants are provided with a standardized light lunch.&#xD;
&#xD;
      A thorough cardiac ultrasound, as well as assessment of major arteries (aorta, carotid,&#xD;
      brachial) structure and function are performed. Pulmonary function tests are done before a&#xD;
      fitness test for VO2 max, and repeated with bronchodilatator after the fitness test.&#xD;
&#xD;
      Prior to leaving, participants are given a ambulatory blood pressure monitor for them to&#xD;
      carry for 24 consecutive hours over the following 2 days.&#xD;
&#xD;
      Prior to the study day, participants are sent questionnaires to be filled in advance by&#xD;
      themselves and by each of their parent. During the study day, other questionnaires regarding&#xD;
      their lifestyles and medical condition are also filled. Overall, information is obtained&#xD;
      about:&#xD;
&#xD;
      (1) Socio-economic status: Occupation, education level and income of participant and parents.&#xD;
      (2) Family history: Parental health (including maternal pregnancies) and familial (1st and&#xD;
      2nd degree) premature history of cardiovascular diseases (CVD), type-2 diabetes, chronic&#xD;
      pulmonary or renal diseases. (3) Personal medical history: Current medication use (including&#xD;
      anti-inflammatory medications), medical history, current symptoms, and growth parameters from&#xD;
      birth to present (according to medical records and child health care booklet), age at&#xD;
      menarche.&#xD;
&#xD;
      (4) Health-related behaviors: (a) regular physical activities (Minnesota and Huet validated&#xD;
      questionnaires) (b) Smoking and alcohol consumption. (c) Diet assessed through the validated&#xD;
      and self-administered 73-item Food Frequency Questionnaire (FFQ). (d) SF-36 Health Survey.&#xD;
&#xD;
      In addition to the study protocol, the subjects are invited to contribute extra biosamples to&#xD;
      our blood (3 ml) and urine (1 ml) biobank.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 1, 2011</start_date>
  <completion_date type="Actual">April 29, 2017</completion_date>
  <primary_completion_date type="Actual">March 29, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <target_duration>1 Day</target_duration>
  <primary_outcome>
    <measure>Markers of inflammation</measure>
    <time_frame>1 hour</time_frame>
    <description>Blood samples for measurements of biomarkers of inflammation are collected in the morning the day of the visit. Monocyte chemoattractant-1 (pg/mL), Interleukine-6 (pg/mL), tumor necrosis factor-alpha (pg/mL), intercellular adhesion molecule-1 (pg/mL), vascular cell adhesion molecule-1 (pg/mL), high-sensitivity C-reactive protein (pg/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of oxydative stress in the blood</measure>
    <time_frame>1 hour</time_frame>
    <description>Blood samples for measurements of biomarkers of oxidative stress are collected in the morning the day of the visit. Blood : Glutathione (GSH and GSSG (nmol/mg of proteins)) and Redox potential using the Nernst equation and the values of GSH and GSSG (mV).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of oxydative stress in the urine</measure>
    <time_frame>1 hour</time_frame>
    <description>Urine 8-prostaglandin F2-alpha (pg/mL).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Markers of oxydative stress in the plasma</measure>
    <time_frame>1 hour</time_frame>
    <description>Oxidized LDL (U/L)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: blood pressure</measure>
    <time_frame>1 hour</time_frame>
    <description>Blood pressure (mmHg)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1</measure>
    <time_frame>30 min</time_frame>
    <description>Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the LV mass (g) indexed to body surface area (BSA in m2) giving a unit of g/m2.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2</measure>
    <time_frame>30 min</time_frame>
    <description>Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the interventricular septum thickness (cm).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3</measure>
    <time_frame>30 min</time_frame>
    <description>Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by LV dysfunction (%) or by endocardial fractional shortening (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.</measure>
    <time_frame>1 hour</time_frame>
    <description>Arterial structure and function (mm) will be measured using a Dopller ultrasound.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1</measure>
    <time_frame>15 min</time_frame>
    <description>Body mass index in kg/m2, calculating using the weight in kg and the height in m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2</measure>
    <time_frame>30 min</time_frame>
    <description>Using lean and fat body (g) m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis</measure>
    <time_frame>2 hours</time_frame>
    <description>Plasma fasting glucose (mmol/L) and insulin (mmol/L) and different times after a 75 g of glucose load.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile</measure>
    <time_frame>1 hour</time_frame>
    <description>Plasma triglycerides (mmol/L), HDL (mmol/L) and LDL (mmol/L).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1</measure>
    <time_frame>30 min</time_frame>
    <description>Urinary protein excretion (albumin/creatinine ratio, mg/mmol), eGFR cystatin C (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2</measure>
    <time_frame>15 min</time_frame>
    <description>Use of the eGFR cystatin C formula (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1</measure>
    <time_frame>30 min</time_frame>
    <description>FEV (%)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2</measure>
    <time_frame>30 min</time_frame>
    <description>Airflow obstruction (FEV1/FVC ratio, no units).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1</measure>
    <time_frame>2 hours</time_frame>
    <description>Determinants of health. Questionnaires about socio-economics status, family history, personal medical history.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2</measure>
    <time_frame>2 hours</time_frame>
    <description>Determinants of health. Maternal obstetrical and subjects neonatal history.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3</measure>
    <time_frame>2 hours</time_frame>
    <description>Determinants of health. Health-related behaviors</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4</measure>
    <time_frame>2 hours</time_frame>
    <description>Determinants of health. Food frequency questionnaire</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Prematurity; Extreme</condition>
  <arm_group>
    <arm_group_label>Extremely preterm (EPT)</arm_group_label>
    <description>All adults born at gestational age (GA) &lt;29 wks at CHU Sainte-Justine (CHUSJ), the Royal Victoria Hospital (RVH), and the Jewish General Hospital (JGH), Montreal, in 1987-97.&#xD;
Inclusion criteria: (a) Birth at GA&lt;29 wks, (b) age 18-29 years at the time of assessment (age of peak human physiological function).&#xD;
Exclusion criteria: (a) currently pregnant due to X-ray related risks, (b) severe neurosensory deficit preventing test completion. In case of twins (or +), if both fulfil inclusion criteria, only one will selected (random) to participate to the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Term or controls</arm_group_label>
    <description>Same-sex friends identified by EPT subject who have accepted to be contacted. Inclusion criteria: (a) Birth at GA ≥37 wks, (b) born in Quebec, to account for health care access during pregnancy and throughout infancy/childhood, (c) birth date within 2 years of index case, (d) age 18-29 years at the time of assessment, (e) same self-reported race as preterm participant.&#xD;
Exclusion criteria: (a) currently pregnant due to X-ray related risks, (b) severe neurosensory deficit preventing test completion.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>preterm birth</intervention_name>
    <description>The study compares young adult subjects born premature (&lt; 29 weeks) versus term (-&gt; 37 weeks)</description>
    <arm_group_label>Extremely preterm (EPT)</arm_group_label>
    <arm_group_label>Term or controls</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The team collected the blood and urine of the participants. They kept whole blood and urine&#xD;
      the the biobank. The group also isolated the plasma and serum to perform assays.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All adults born at GA&lt;29 wks at CHU Sainte-Justine, the Royal Victoria Hospital, and the&#xD;
        Jewish General Hospital, Montreal, in 1987-97. For each EPT subject, a friend control&#xD;
        matched on sex is selected to control in part for lifestyle and social factors (e.g. diet,&#xD;
        physical activity, health care visits), and environmental exposure that may affect&#xD;
        inflammatory status and disease risk. Indeed, given the known link between lower&#xD;
        socio-economic status, lifestyle habits and CVD risk factors, and that women from lower SES&#xD;
        and with poor lifestyle behaviors are at increased risk to deliver prematurely, a friend&#xD;
        control, who is more likely to have evolved in a similar milieu, will allow us to better&#xD;
        isolate the effect of preterm birth on studied outcomes from socio-environmental factors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        EPT :&#xD;
&#xD;
          -  Birth at GA&lt;29 wks&#xD;
&#xD;
          -  Age 18-29 years at the time of assessment (age of peak human physiological function)&#xD;
&#xD;
        Terms:&#xD;
&#xD;
          -  Birth at GA ≥37 wks&#xD;
&#xD;
          -  Born in Quebec, to account for health care access during pregnancy and throughout&#xD;
             infancy/childhood&#xD;
&#xD;
          -  Birth date within 2 years of index case&#xD;
&#xD;
          -  Age 18-29 years at the time of assessment&#xD;
&#xD;
          -  Same self-reported race as preterm participant.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Both groups :&#xD;
&#xD;
          -  Currently pregnant due to X-ray related risks&#xD;
&#xD;
          -  Severe neurosensory deficit preventing test completion.&#xD;
&#xD;
          -  In case of twins (or +), if both fulfil inclusion criteria, only one will selected&#xD;
             (random) to participate to the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>The extremely preterm subjects need to come with a same sex born term subject.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Anne Monique Nuyt, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Thuy Mai Luu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Justine's Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>StJustine's Hospital</name>
      <address>
        <city>Montréal</city>
        <state>Quebec</state>
        <zip>H3T 1C5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <last_update_submitted>November 2, 2022</last_update_submitted>
  <last_update_submitted_qc>November 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Justine's Hospital</investigator_affiliation>
    <investigator_full_name>Anne Monique NUYT,MD</investigator_full_name>
    <investigator_title>MD, Professor of Pediatrics</investigator_title>
  </responsible_party>
  <keyword>extremely preterm</keyword>
  <keyword>young adults</keyword>
  <keyword>CVD risks factors</keyword>
  <keyword>inflammation</keyword>
  <keyword>chronic health conditions</keyword>
  <keyword>term</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>all IPD that underlie results in a publication</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_time_frame>Starting 1 year after all results of the study are published.</ipd_time_frame>
    <ipd_access_criteria>Request of collaboration through data access will be examined by the PI's.</ipd_access_criteria>
  </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/NCT03261609
org study id: HAPI clinical project
nct id: NCT03261609
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the HAPI project is to study the overall health of preterm infants once they
      reach adulthood. The investigators would like to compare the health of adults born preterm
      with that of adults born full-term. They would also like to find the early signs, or
      biomarkers, of chronic diseases such as high blood pressure, diabetes, osteoporosis, and
      chronic lung diseases.

      Such biomarkers would allow for early diagnosis and prevention. Furthermore, the
      investigators would like to understand why some people born preterm are more likely to
      develop chronic disease. They believe that inflammation and oxidative stress may play a part.
      Oxidative stress is present when the body is not able to defend itself against oxygen-derived
      products that can damage our cells.

      To carry out this study, the investigators will examine 6 aspects of the health: (1) heart
      and circulation, (2) kidneys, (3) lungs, (4) metabolism - sugars and fats in the blood, (5)
      bones, and (6) eyes.
The participants, from both groups will spend a whole day at St. Justine's hospital. Upon
      arrival after an overnight fast, vital signs and anthropometric measures are taken. Then
      blood and urine are obtained as well and a pregnancy test is performed for women. After
      inserting a intravenous catheter, around 55 mL of blood is taken and sent to the biochemistry
      department and to our laboratory. A oral glucose tolerance test is also performed with blood
      sampling over 2hours.

      Then a renal and carotid ultrasounds, as well as a osteodensitometry test (bone mineral
      density and body muscle/fat composition) are done. Ophtalmology exam is realized by
      ophtalmologist, including visual acuity, contrast and fundus photograph, then the
      participants are provided with a standardized light lunch.

      A thorough cardiac ultrasound, as well as assessment of major arteries (aorta, carotid,
      brachial) structure and function are performed. Pulmonary function tests are done before a
      fitness test for VO2 max, and repeated with bronchodilatator after the fitness test.

      Prior to leaving, participants are given a ambulatory blood pressure monitor for them to
      carry for 24 consecutive hours over the following 2 days.

      Prior to the study day, participants are sent questionnaires to be filled in advance by
      themselves and by each of their parent. During the study day, other questionnaires regarding
      their lifestyles and medical condition are also filled. Overall, information is obtained
      about:

      (1) Socio-economic status: Occupation, education level and income of participant and parents.
      (2) Family history: Parental health (including maternal pregnancies) and familial (1st and
      2nd degree) premature history of cardiovascular diseases (CVD), type-2 diabetes, chronic
      pulmonary or renal diseases. (3) Personal medical history: Current medication use (including
      anti-inflammatory medications), medical history, current symptoms, and growth parameters from
      birth to present (according to medical records and child health care booklet), age at
      menarche.

      (4) Health-related behaviors: (a) regular physical activities (Minnesota and Huet validated
      questionnaires) (b) Smoking and alcohol consumption. (c) Diet assessed through the validated
      and self-administered 73-item Food Frequency Questionnaire (FFQ). (d) SF-36 Health Survey.

      In addition to the study protocol, the subjects are invited to contribute extra biosamples to
      our blood (3 ml) and urine (1 ml) biobank.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Markers of inflammation
time frame: 1 hour
description: Blood samples for measurements of biomarkers of inflammation are collected in the morning the day of the visit. Monocyte chemoattractant-1 (pg/mL), Interleukine-6 (pg/mL), tumor necrosis factor-alpha (pg/mL), intercellular adhesion molecule-1 (pg/mL), vascular cell adhesion molecule-1 (pg/mL), high-sensitivity C-reactive protein (pg/mL).
measure: Markers of oxydative stress in the blood
time frame: 1 hour
description: Blood samples for measurements of biomarkers of oxidative stress are collected in the morning the day of the visit. Blood : Glutathione (GSH and GSSG (nmol/mg of proteins)) and Redox potential using the Nernst equation and the values of GSH and GSSG (mV).
measure: Markers of oxydative stress in the urine
time frame: 1 hour
description: Urine 8-prostaglandin F2-alpha (pg/mL).
measure: Markers of oxydative stress in the plasma
time frame: 1 hour
description: Oxidized LDL (U/L)
measure: CVD risk factors and indicators of (sub)clinical disease: blood pressure
time frame: 1 hour
description: Blood pressure (mmHg)
measure: CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1
time frame: 30 min
description: Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the LV mass (g) indexed to body surface area (BSA in m2) giving a unit of g/m2.
measure: CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2
time frame: 30 min
description: Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the interventricular septum thickness (cm).
measure: CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3
time frame: 30 min
description: Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by LV dysfunction (%) or by endocardial fractional shortening (%)
measure: CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.
time frame: 1 hour
description: Arterial structure and function (mm) will be measured using a Dopller ultrasound.
measure: CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1
time frame: 15 min
description: Body mass index in kg/m2, calculating using the weight in kg and the height in m
measure: CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2
time frame: 30 min
description: Using lean and fat body (g) m
measure: CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis
time frame: 2 hours
description: Plasma fasting glucose (mmol/L) and insulin (mmol/L) and different times after a 75 g of glucose load.
measure: CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile
time frame: 1 hour
description: Plasma triglycerides (mmol/L), HDL (mmol/L) and LDL (mmol/L).
measure: CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1
time frame: 30 min
description: Urinary protein excretion (albumin/creatinine ratio, mg/mmol), eGFR cystatin C (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).
measure: CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2
time frame: 15 min
description: Use of the eGFR cystatin C formula (cystatin C : mg/L) (mL/min/1.73 m2). The formula use the cystatin C values in mg/mL, the standardized serum cystatin min and max, the age (in years) and the sex (female: 0.932, male : 1).
measure: CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1
time frame: 30 min
description: FEV (%)
measure: CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2
time frame: 30 min
description: Airflow obstruction (FEV1/FVC ratio, no units).
measure: CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1
time frame: 2 hours
description: Determinants of health. Questionnaires about socio-economics status, family history, personal medical history.
measure: CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2
time frame: 2 hours
description: Determinants of health. Maternal obstetrical and subjects neonatal history.
measure: CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3
time frame: 2 hours
description: Determinants of health. Health-related behaviors
measure: CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4
time frame: 2 hours
description: Determinants of health. Food frequency questionnaire
arm group label: Extremely preterm (EPT)
description: All adults born at gestational age (GA) <29 wks at CHU Sainte-Justine (CHUSJ), the Royal Victoria Hospital (RVH), and the Jewish General Hospital (JGH), Montreal, in 1987-97.
Inclusion criteria: (a) Birth at GA<29 wks, (b) age 18-29 years at the time of assessment (age of peak human physiological function).
Exclusion criteria: (a) currently pregnant due to X-ray related risks, (b) severe neurosensory deficit preventing test completion. In case of twins (or +), if both fulfil inclusion criteria, only one will selected (random) to participate to the study.
arm group label: Term or controls
description: Same-sex friends identified by EPT subject who have accepted to be contacted. Inclusion criteria: (a) Birth at GA ≥37 wks, (b) born in Quebec, to account for health care access during pregnancy and throughout infancy/childhood, (c) birth date within 2 years of index case, (d) age 18-29 years at the time of assessment, (e) same self-reported race as preterm participant.
Exclusion criteria: (a) currently pregnant due to X-ray related risks, (b) severe neurosensory deficit preventing test completion.
intervention type: Other
intervention name: preterm birth
description: The study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks)
arm group label: Extremely preterm (EPT)
arm group label: Term or controls
The team collected the blood and urine of the participants. They kept whole blood and urine
      the the biobank. The group also isolated the plasma and serum to perform assays.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: The extremely preterm subjects need to come with a same sex born term subject.
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Anne Monique Nuyt, MD
role: Principal Investigator
affiliation: St. Justine's Hospital
last name: Thuy Mai Luu, MD
role: Principal Investigator
affiliation: St. Justine's Hospital
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: St. Justine's Hospital
investigator full name: Anne Monique NUYT,MD
investigator title: MD, Professor of Pediatrics
mesh term: Inflammation
mesh term: Chronic Disease
sharing ipd: Yes
ipd description: all IPD that underlie results in a publication
ipd info type: Study Protocol
ipd info type: Informed Consent Form (ICF)
ipd time frame: Starting 1 year after all results of the study are published.
ipd access criteria: Request of collaboration through data access will be examined by the PI's.