Risk of Chronic Diseases in Young Adults Born Preterm: Relationship With Inflammation and Oxidative Stress Biomarkers.

NCT ID: NCT03261609

Last Updated: 2022-11-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-12-01

Study Completion Date

2017-04-29

Brief Summary

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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

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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

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Prematurity; Extreme

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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.

preterm birth

Intervention Type OTHER

The study compares young adult subjects born premature (\< 29 weeks) versus term (-\> 37 weeks)

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.

preterm birth

Intervention Type OTHER

The study compares young adult subjects born premature (\< 29 weeks) versus term (-\> 37 weeks)

Interventions

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preterm birth

The study compares young adult subjects born premature (\< 29 weeks) versus term (-\> 37 weeks)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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
* Birth date within 2 years of index case
* Age 18-29 years at the time of assessment
* Same self-reported race as preterm participant.

Exclusion Criteria

Both groups :

* Currently pregnant due to X-ray related risks
* Severe neurosensory deficit preventing test completion.
Minimum Eligible Age

18 Years

Maximum Eligible Age

29 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jewish General Hospital

OTHER

Sponsor Role collaborator

McGill University Health Centre/Research Institute of the McGill University Health Centre

OTHER

Sponsor Role collaborator

St. Justine's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Anne Monique NUYT,MD

MD, Professor of Pediatrics

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Monique Nuyt, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Thuy Mai Luu, MD

Role: PRINCIPAL_INVESTIGATOR

St. Justine's Hospital

Locations

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StJustine's Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

References

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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.

Reference Type DERIVED
PMID: 34961326 (View on PubMed)

Dartora 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.

Reference Type DERIVED
PMID: 33549599 (View on PubMed)

Gervais 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.

Reference Type DERIVED
PMID: 32120379 (View on PubMed)

Flahault 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.

Reference Type DERIVED
PMID: 31983307 (View on PubMed)

Paquette 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.

Reference Type DERIVED
PMID: 30354721 (View on PubMed)

Other Identifiers

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HAPI clinical project

Identifier Type: -

Identifier Source: org_study_id

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