RecruitingNAINTERVENTIONAL

Safety and PK-PD Study of Oral L-CIT in Preterm Infants With BPD±PH and NEC

This research study is looking into a natural substance called L-Citrulline. It's often found in our bodies and in some foods. We want to see if giving L-Citrulline to premature babies is safe and how it affects them. Premature babies can have serious health problems like Bronchopulmonary Dysplasia (BPD), a lung condition often linked with Pulmonary Hypertension (PH), or Necrotizing Enterocolitis (NEC), a severe gut issue. These conditions involve inflammation. L-Citrulline might help reduce this inflammation and improve blood flow. By understanding how L-Citrulline works in these vulnerable babies, we hope to find new ways to help them develop better and avoid these health challenges.

At a glance

Status

Recruiting

Phase

Sponsor

The Hospital for Sick Children

Enrolment target

Start

01 Nov 2023

Estimated completion

01 Mar 2028

BPD - Bronchopulmonary Dysplasia Pulmonary Hypertension NEC

What is this study about?

When babies are born very early (prematurely), their tiny bodies and immune systems aren't fully developed. This means they are more likely to get sick and face health challenges. Two serious conditions that can affect premature babies are Bronchopulmonary Dysplasia (BPD), which affects their lungs, and Necrotizing Enterocolitis (NEC), which is a serious problem with their gut. Sometimes, BPD can also involve Pulmonary Hypertension (PH), which is high blood pressure in the lungs. These conditions often involve a lot of inflammation in the body.

This study is looking at a natural substance called L-Citrulline. L-Citrulline is an amino acid, which is a building block of protein. Our bodies make it, and it can help produce something called nitric oxide, which is important for healthy blood flow and can also help reduce inflammation. We know that in babies with BPD, PH, or NEC, there might be lower levels of L-Citrulline or related substances in their bodies.

Our aim is to understand if giving L-Citrulline as a supplement to premature babies is safe, and how their bodies handle it. We want to see if it helps these babies, particularly those recovering from NEC surgery or those with early signs of BPD and PH. By carefully studying L-Citrulline, we hope to learn more about how it works and whether it could be a helpful way to support these vulnerable infants.

Key takeaways

The study explores L-Citrulline for premature babies.
It aims to understand safety and how L-Citrulline affects their bodies.
Focuses on babies with lung problems (BPD/PH) or gut issues (NEC).
L-Citrulline is a natural substance that may reduce inflammation.
Participation involves close monitoring and routine medical checks.

Who may be eligible?

To join this study, your baby needs to have been born at 30 weeks of pregnancy or earlier. They also need to be at least 32 weeks past their original due date (if they were born on time).

There are two main groups of babies we're looking for. One group is babies who are showing early signs of lung problems like BPD, especially if they also have high blood pressure in their lungs (PH). These babies would need to be breathing with help (like a ventilator) for a certain amount of time. The other group is babies who are recovering from serious gut surgery for a condition called NEC and are starting to tolerate some milk feeds.

There are also some reasons why a baby might not be able to join. For example, if they have certain heart conditions (though very small, common heart issues are usually okay), a specific lung vein problem, a severe infection that isn't stable, or if their doctors believe they are very unwell and might not survive the next week. The study team will review all your baby's health details to make sure it's safe for them to take part.

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.

Was your baby born at 30 weeks or earlier?
Is your baby now at least 32 weeks past their 'due date'?
Does your baby have early lung problems (BPD/PH) or is recovering from serious gut surgery (NEC)?
Is your baby generally stable and not extremely unwell?
Does your baby have any serious heart conditions beyond very small, common ones?

Answer every question to see your result.

What does participation involve?

If your baby joins this study, they will receive L-Citrulline, which is a natural substance. The study team will explain exactly how it will be given. Your baby will have regular check-ups, and the doctors will closely monitor their health. This will include blood tests and possibly other routine tests they would be having anyway, to see how their body is handling the L-Citrulline and if it's having any effects. The study also involves follow-up appointments to track your baby's progress. The total length of your baby's participation in the study will be discussed with you by the research team.

Potential risks and benefits

Participating in this study might offer a potential benefit by helping us understand if L-Citrulline can improve outcomes for premature babies with challenging conditions. It's possible your baby could benefit from the close monitoring and care they receive as part of the study. However, like any medical research, there could be potential risks, such as side effects from the L-Citrulline, though it's a natural substance. The study team will discuss all known and potential risks with you in detail. You are always free to withdraw your baby from the study at any time, for any reason, without affecting their standard medical care.

Locations (1)

The Hospital For Sick Children
Verified postcode
Toronto, Canada· Recruiting

Common questions

What is L-Citrulline?

L-Citrulline is a natural building block of protein found in our bodies. It helps make other important substances that support healthy blood flow and reduce inflammation.

Why is this study important for premature babies?

Premature babies are at risk of serious conditions like lung problems (BPD/PH) and gut issues (NEC). We want to see if L-Citrulline can safely help prevent or improve these conditions by reducing inflammation and improving blood flow.

Will my baby definitely get L-Citrulline?

Yes, if your baby is eligible and you agree for them to take part, they will receive L-Citrulline as part of this study.

What kind of tests will my baby have?

Your baby will have regular checks, including blood tests. These tests are to monitor their health and see how their body is responding to the L-Citrulline. Many of these might be tests they would have anyway as part of their care.

Can I change my mind about my baby being in the study?

Yes, you have the right to withdraw your baby from the study at any time, for any reason, without it affecting their normal medical care.

How to find out more

Rachana Patel, MSc, CCRP

rachana.patel@sickkids.ca +1(416)-813-7654 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.