Active not recruitingOBSERVATIONAL

Assessment of Renal Function in Adults Born Preterm: The HAPI-Kidney Study

This study, called HAPI-Kidney, is investigating the long-term impact of being born very prematurely on kidney health in adults. When babies are born very early (before 29 weeks of pregnancy), their kidneys might not develop fully. This could lead to kidney problems and high blood pressure later in life. We're studying adults who were born prematurely and comparing their kidney function and blood pressure with adults who were born at full-term. We want to understand how their kidneys are working, look at certain chemicals in their blood that affect kidneys, and see how these change over time. The information we gather will help us identify early signs of kidney issues and develop better ways to monitor and support people who were born prematurely throughout their lives.

At a glance

Status

Active not recruiting

Sponsor

St. Justine's Hospital

Enrolment target

157

Start

26 Jun 2021

Estimated completion

30 Dec 2025

Prematurity; Extreme

What is this study about?

When a baby is born very early, specifically before 29 weeks of pregnancy, it happens during an important time for kidney development. This can mean their kidneys might not form as many filtering units (called nephrons) as they would if they were born at full-term. Over time, this could potentially put extra strain on their kidneys, leading to changes in how they work and even increase the risk of high blood pressure. There's still a lot we don't know about these long-term effects on kidney health, and existing studies haven't always been clear-cut.

The HAPI-Kidney study aims to learn more about how being born prematurely affects kidney function in young adults. We will be carefully measuring how well their kidneys are filtering waste and looking at certain hormones in their blood that influence kidney activity and blood pressure. We'll compare these measurements to those of adults who were born at full-term. We're also curious about how these measures change over a five-year period.

The goal is to gain a much clearer picture of kidney health in adults born prematurely. By understanding the specific changes and potential problems, we hope to find early warning signs of kidney issues. This knowledge could help doctors develop new guidelines for monitoring people who were born prematurely, allowing for earlier support and interventions to keep their kidneys healthy for as long as possible.

Key takeaways

This study investigates kidney health in adults born very prematurely.
It aims to understand long-term effects of early birth on kidneys and blood pressure.
Researchers will compare kidney function of adults born early to those born at full-term.
The findings could lead to better monitoring and care for individuals born prematurely.
Participation involves various kidney tests and blood pressure checks over time.

Who may be eligible?

This study is looking for two groups of participants: adults who were born very prematurely, at 29 weeks of pregnancy or earlier, and a comparison group of adults who were born at full-term, meaning between 37 and 41 weeks of pregnancy. All participants need to be between 18 and 40 years old.

For those in the full-term comparison group, we also need to confirm they weighed more than 2.5 kilograms (about 5.5 pounds) at birth. People with Type 2 diabetes can take part in this study.

However, some people won't be able to join. This includes anyone who is currently pregnant, has severe difficulties with their sight, hearing, or movement that would make it hard to complete the tests, or has a pre-existing kidney disease that isn't related to being born prematurely. This is because we want to focus specifically on the effects of premature birth.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 40 years old?
Were you born before or at 29 weeks of pregnancy (or between 37-41 weeks with a birth weight over 2.5kg)?
Are you currently not pregnant?
Do you not have a pre-existing kidney disease unrelated to being born early?

Answer every question to see your result.

What does participation involve?

We don’t have all the details about what your participation would involve right now, such as the exact number of visits or the total length of the study. However, based on the information we do have, it’s likely to involve:

* **Detailed Kidney Tests:** These will probably include very precise measurements of how well your kidneys are filtering waste, as well as blood and urine tests to check various kidney markers and hormones that affect blood pressure. * **Blood Pressure Checks:** Regular and careful measurements of your blood pressure will be taken. * **Kidney Scans:** You might have imaging tests, such as an MRI scan, to look at your kidney size and structure. If there's a reason you can't have an MRI, we'd still want you to do the other tests. * **Follow-up Over Time:** The study mentions evaluating changes over a five-year period, suggesting there will be follow-up appointments over several years to track your kidney health and blood pressure trends.

You won't be given any new medications specifically for the study. The assessments will help researchers understand your body's natural function.

Potential risks and benefits

Taking part in this study could help us learn valuable information about kidney health in people born prematurely, potentially leading to better care in the future for many individuals. You might also gain a better understanding of your own kidney health through the assessments. While participation is generally safe, some procedures like blood tests or scans carry small risks, such as minor discomfort from a needle stick or exposure to a small amount of radiation from certain kidney function tests. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

StJustine's Hospital
Verified postcode
Montreal, Canada

Common questions

What does 'preterm birth' mean in this study?

In this study, 'preterm birth' refers to babies born very early, specifically at or before 29 weeks of pregnancy.

Why are you focusing on kidneys?

Kidneys develop significantly during pregnancy. Being born very early might affect how kidneys form, potentially leading to long-term health differences like changes in kidney function or blood pressure.

Will I receive any treatment as part of this study?

No, this study is observational, meaning we will be gathering information about your health. You won't receive specific treatments or medications as part of the research.

What is 'glomerular function'?

Glomerular function refers to how well the tiny filters in your kidneys, called glomeruli, are working to clean your blood. It's a key measure of kidney health.

How long will I need to be involved in the study?

The study mentions looking at changes over a five-year period, so it is likely to involve follow-up appointments over several years.