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

NCT03261609 | Completed

• 1 other identifier: HAPI clinical project
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Prematurity; Extreme

Keywords

extremely preterm; young adults; CVD risks factors; inflammation; chronic health conditions; term

Outcome Measures

Primary Outcomes (4)

• 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).

  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).

  1 hour

• Markers of oxydative stress in the urine

  Urine 8-prostaglandin F2-alpha (pg/mL).

  1 hour

• Markers of oxydative stress in the plasma

  Oxidized LDL (U/L)

  1 hour

Secondary Outcomes (17)

• CVD risk factors and indicators of (sub)clinical disease: blood pressure

  1 hour

• CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #1

  30 min

• CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography- LV hypertrophy #2

  30 min

• CVD risk factors and indicators of (sub)clinical disease: Cardiac structure and function by echocardiography -LV hypertrophy #3

  30 min

• CVD risk factors and indicators of (sub)clinical disease: Arterial structure and function by ultrasound.

  1 hour

Study Arms (2)

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.

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.

Other: preterm birth

Interventions

preterm birth OTHER

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

Extremely preterm (EPT); Term or controls

Eligibility Criteria

• Age: 18 Years - 29 Years
• Gender Eligibility Details: The extremely preterm subjects need to come with a same sex born term subject.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• Both groups :
• Currently pregnant due to X-ray related risks
• Severe neurosensory deficit preventing test completion.

Sponsors & Collaborators

• St. Justine's Hospital: lead
• Jewish General Hospital: collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: collaborator

Study Sites (1)

StJustine's Hospital

Montreal, Quebec, H3T 1C5, Canada

Location

Related Publications (5)

• 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.

  PMID: 34961326 DERIVED

• 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.

  PMID: 33549599 DERIVED

• 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.

  PMID: 32120379 DERIVED

• 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.

  PMID: 31983307 DERIVED

• 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.

  PMID: 30354721 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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.

MeSH Terms

Conditions

Premature Birth; Inflammation

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Monique Nuyt, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

• Thuy Mai Luu, MD

  St. Justine's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Professor of Pediatrics

Study Record Dates

• First Submitted: July 28, 2017
• First Posted: August 25, 2017
• Study Start: December 1, 2011
• Primary Completion: March 29, 2017
• Study Completion: April 29, 2017
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 1 year after all results of the study are published.
• Access Criteria: Request of collaboration through data access will be examined by the PI's.

Locations

CA (1)