Prematurity; ExtremeNCT03261609
Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
An observational study of Prematurity; Extreme, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Prematurity; Extreme
- What is being tested?
- preterm birth
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 Dec 2011to 29 Apr 2017
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: All adults born at GA<29 wks at CHU Sainte-Justine, the Royal Victoria Hospital, and the Jewish General Hospital, Montreal, in 1987-97. For each EPT subject, a friend control matched on sex is selected to control in part for lifestyle and social factors (e.g. diet, physical activity, health care visits), and environmental exposure that may affect inflammatory status and disease risk. Indeed, given the known link between lower socio-economic status, lifestyle habits and CVD risk factors, and that women from lower SES and with poor lifestyle behaviors are at increased risk to deliver prematurely, a friend control, who is more likely to have evolved in a similar milieu, will allow us to better isolate the effect of preterm birth on studied outcomes from socio-environmental factors.
Who may be able to join
- EPT :
- Birth at GA<29 wks
- Age 18-29 years at the time of assessment (age of peak human physiological function)
- Terms:
- Birth at GA ≥37 wks
- Born in Quebec, to account for health care access during pregnancy and throughout infancy/childhood
Show all 9Show fewer
- Birth date within 2 years of index case
- Age 18-29 years at the time of assessment
- Same self-reported race as preterm participant.
Who cannot join
- Both groups :
- Currently pregnant due to X-ray related risks
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Prematurity; Extreme
- Being tested
- preterm birth
- Keywords
- extremely preterm, young adults, CVD risks factors, inflammation, chronic health conditions, term
- Medical subject headings
- Premature Birth, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preterm birthOther
The study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks)
| Study group | Role | What they receive |
|---|---|---|
| Extremely preterm (EPT) | 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. Receives: Other: preterm birth | |
| Term or controls | 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. Receives: Other: preterm birth |
What is being measured
The primary outcome is the main question the study is designed to answer.
Markers of inflammation
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).
Measured: 1 hour
Markers of oxydative stress in the blood
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).
Measured: 1 hour
Markers of oxydative stress in the urine
Urine 8-prostaglandin F2-alpha (pg/mL).
Measured: 1 hour
Markers of oxydative stress in the plasma
Oxidized LDL (U/L)
Measured: 1 hour
Secondary outcomes (17)
CVD risk factors and indicators of (sub)clinical disease: blood pressure
Blood pressure (mmHg)
Measured: 1 hour
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1
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.
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2
Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by the interventricular septum thickness (cm).
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3
Cardiac structure and function by echocardiography. Left ventricle hypertrophy determined by LV dysfunction (%) or by endocardial fractional shortening (%)
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.
Arterial structure and function (mm) will be measured using a Dopller ultrasound.
Measured: 1 hour
CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1
Body mass index in kg/m2, calculating using the weight in kg and the height in m
Measured: 15 min
CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2
Using lean and fat body (g) m
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis
Plasma fasting glucose (mmol/L) and insulin (mmol/L) and different times after a 75 g of glucose load.
Measured: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile
Plasma triglycerides (mmol/L), HDL (mmol/L) and LDL (mmol/L).
Measured: 1 hour
CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1
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).
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2
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).
Measured: 15 min
CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1
FEV (%)
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2
Airflow obstruction (FEV1/FVC ratio, no units).
Measured: 30 min
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1
Determinants of health. Questionnaires about socio-economics status, family history, personal medical history.
Measured: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2
Determinants of health. Maternal obstetrical and subjects neonatal history.
Measured: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3
Determinants of health. Health-related behaviors
Measured: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4
Determinants of health. Food frequency questionnaire
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2017
- Study start1 Dec 2011
- Primary completion29 Mar 2017
- Study completion29 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Prematurity; ExtremeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Responsible party
- Principal investigator, Anne Monique NUYT,MD, St. Justine's Hospital
- Investigators
- Anne Monique Nuyt, MD, Principal investigator, St. Justine's HospitalThuy Mai Luu, MD, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261609
- Sponsor's protocol ID
- HAPI clinical project
- Status last verified
- Nov 2022
- First submitted
- 28 Jul 2017
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Publications
Ravizzoni Dartora D, Flahault A, Pontes CNR, He Y, Deprez A, Cloutier A, Cagnone G, Gaub P, Altit G, Bigras JL, Joyal JS, Mai Luu T, Burelle Y, Nuyt AM. Cardiac Left Ventricle Mitochondrial Dysfunction After Neonatal Exposure to Hyperoxia: Relevance for Cardiomyopathy After Preterm Birth. Hypertension. 2022 Mar;79(3):575-587. doi: 10.1161/HYPERTENSIONAHA.121.17979. Epub 2021 Dec 28.
PubMed 34961326Dartora DR, Flahault A, Luu TM, Cloutier A, Simoneau J, White M, Lapointe A, Villeneuve A, Bigras JL, Altit G, Nuyt AM. Association of Bronchopulmonary Dysplasia and Right Ventricular Systolic Function in Young Adults Born Preterm. Chest. 2021 Jul;160(1):287-296. doi: 10.1016/j.chest.2021.01.079. Epub 2021 Feb 5.
PubMed 33549599Gervais AS, Flahault A, Chan T, Bastien-Tardif C, Al-Simaani A, Cloutier A, Luu TM, Abadir S, Nuyt AM. Electrocardiographic features at rest and during exercise in young adults born preterm below 30 weeks of gestation. Pediatr Res. 2020 Aug;88(2):305-311. doi: 10.1038/s41390-020-0814-9. Epub 2020 Mar 2.
PubMed 32120379Flahault A, Paquette K, Fernandes RO, Delfrate J, Cloutier A, Henderson M, Lavoie JC, Masse B, Nuyt AM, Luu TM; HAPI collaborating group*. Increased Incidence but Lack of Association Between Cardiovascular Risk Factors in Adults Born Preterm. Hypertension. 2020 Mar;75(3):796-805. doi: 10.1161/HYPERTENSIONAHA.119.14335. Epub 2020 Jan 27.
PubMed 31983307Paquette K, Fernandes RO, Xie LF, Cloutier A, Fallaha C, Girard-Bock C, Mian MOR, Lukaszewski MA, Masse B, El-Jalbout R, Lapeyraque AL, Santos RA, Luu TM, Nuyt AM. Kidney Size, Renal Function, Ang (Angiotensin) Peptides, and Blood Pressure in Young Adults Born Preterm. Hypertension. 2018 Oct;72(4):918-928. doi: 10.1161/HYPERTENSIONAHA.118.11397.
PubMed 30354721
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.
- ClinicalTrials.gov ID
- NCT03261609
- Acronym / sponsor ID
- HAPI clinical project
- Conditions
- Prematurity; Extreme
- Keywords
- extremely preterm, young adults, CVD risks factors, inflammation, chronic health conditions, term
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Collaborators
- Jewish General Hospital, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Study start
- 1 Dec 2011 (actual)
- Primary completion
- 29 Mar 2017 (actual)
- Study completion
- 29 Apr 2017 (actual)
- First posted
- 25 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Extremely preterm (EPT) | – | Other: preterm birthAll 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. |
| Term or controls | – | Other: preterm birthSame-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. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- All adults born at GA<29 wks at CHU Sainte-Justine, the Royal Victoria Hospital, and the Jewish General Hospital, Montreal, in 1987-97. For each EPT subject, a friend control matched on sex is selected to control in part for lifestyle and social factors (e.g. diet, physical activity, health care visits), and environmental exposure that may affect inflammatory status and disease risk. Indeed, given the known link between lower socio-economic status, lifestyle habits and CVD risk factors, and that women from lower SES and with poor lifestyle behaviors are at increased risk to deliver prematurely, a friend control, who is more likely to have evolved in a similar milieu, will allow us to better isolate the effect of preterm birth on studied outcomes from socio-environmental factors.
Key inclusion criteria (9 listed)
- Birth at GA<29 wks
- Age 18-29 years at the time of assessment (age of peak human physiological function)
- Birth at GA ≥37 wks
- Born in Quebec, to account for health care access during pregnancy and throughout infancy/childhood
- Birth date within 2 years of index case
Key exclusion criteria (4 listed)
- Currently pregnant due to X-ray related risks
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preterm birthThe study compares young adult subjects born premature (< 29 weeks) versus term (-> 37 weeks) | Other | Extremely preterm (EPT), Term or controls |
Primary outcome
Markers of inflammation
Time frame: 1 hour
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).
Markers of oxydative stress in the blood
Time frame: 1 hour
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).
Markers of oxydative stress in the urine
Time frame: 1 hour
Urine 8-prostaglandin F2-alpha (pg/mL).
Markers of oxydative stress in the plasma
Time frame: 1 hour
Oxidized LDL (U/L)
17 secondary outcomes
CVD risk factors and indicators of (sub)clinical disease: blood pressure
Time frame: 1 hour
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.
Time frame: 1 hour
CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #1
Time frame: 15 min
CVD risk factors and indicators of (sub)clinical disease: Adiposity measures #2
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: glucose homeostasis
Time frame: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Fasting lipid profile
Time frame: 1 hour
CVD risk factors and indicators of (sub)clinical disease: kidneys functions #1
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: kidneys functions #2
Time frame: 15 min
CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #1
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: pulmonary functions #2
Time frame: 30 min
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #1
Time frame: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #2
Time frame: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #3
Time frame: 2 hours
CVD risk factors and indicators of (sub)clinical disease: Questionnaires #4
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Derived from this study: PubMed 34961326Ravizzoni Dartora D, Flahault A, Pontes CNR, He Y, Deprez A, Cloutier A, Cagnone G, Gaub P, Altit G, Bigras JL, Joyal JS, Mai Luu T, Burelle Y, Nuyt AM. Cardiac Left Ventricle Mitochondrial Dysfunction After Neonatal Exposure to Hyperoxia: Relevance for Cardiomyopathy After Preterm Birth. Hypertension. 2022 Mar;79(3):575-587. doi: 10.1161/HYPERTENSIONAHA.121.17979. Epub 2021 Dec 28.
- Derived from this study: PubMed 33549599Dartora DR, Flahault A, Luu TM, Cloutier A, Simoneau J, White M, Lapointe A, Villeneuve A, Bigras JL, Altit G, Nuyt AM. Association of Bronchopulmonary Dysplasia and Right Ventricular Systolic Function in Young Adults Born Preterm. Chest. 2021 Jul;160(1):287-296. doi: 10.1016/j.chest.2021.01.079. Epub 2021 Feb 5.
- Derived from this study: PubMed 32120379Gervais AS, Flahault A, Chan T, Bastien-Tardif C, Al-Simaani A, Cloutier A, Luu TM, Abadir S, Nuyt AM. Electrocardiographic features at rest and during exercise in young adults born preterm below 30 weeks of gestation. Pediatr Res. 2020 Aug;88(2):305-311. doi: 10.1038/s41390-020-0814-9. Epub 2020 Mar 2.
- Derived from this study: PubMed 31983307Flahault A, Paquette K, Fernandes RO, Delfrate J, Cloutier A, Henderson M, Lavoie JC, Masse B, Nuyt AM, Luu TM; HAPI collaborating group*. Increased Incidence but Lack of Association Between Cardiovascular Risk Factors in Adults Born Preterm. Hypertension. 2020 Mar;75(3):796-805. doi: 10.1161/HYPERTENSIONAHA.119.14335. Epub 2020 Jan 27.
- Derived from this study: PubMed 30354721Paquette K, Fernandes RO, Xie LF, Cloutier A, Fallaha C, Girard-Bock C, Mian MOR, Lukaszewski MA, Masse B, El-Jalbout R, Lapeyraque AL, Santos RA, Luu TM, Nuyt AM. Kidney Size, Renal Function, Ang (Angiotensin) Peptides, and Blood Pressure in Young Adults Born Preterm. Hypertension. 2018 Oct;72(4):918-928. doi: 10.1161/HYPERTENSIONAHA.118.11397.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Monique Nuyt, MD principal investigator
St. Justine's Hospital
Thuy Mai Luu, MD principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prematurity; Extreme, run by St. Justine's Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Markers of inflammation (time frame: 1 hour). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261609, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Nov 2022.