RecruitingPHASE2INTERVENTIONAL

Oral Propranolol for Prevention of Threshold Retinopathy of Prematurity

This study is investigating a new way to prevent a serious eye condition called Retinopathy of Prelaturity (ROP) in babies born very early. ROP can sometimes cause blindness. Currently, treatment often involves laser surgery or injections directly into the eye, which have costs and side effects. Researchers are looking at a medicine called propranolol, which is given by mouth and is already used for other conditions like high blood pressure. Early small studies suggest it might stop ROP from getting worse. This larger study will involve many hospitals to see if giving propranolol to extremely premature babies can reduce the number of babies who develop severe ROP.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

University of Zurich

Enrolment target

276

Start

22 Sep 2022

Estimated completion

31 Dec 2029

Retinopathy of Prematurity

What is this study about?

When babies are born very prematurely, especially before 28 weeks, their eyes might not have fully developed. This can lead to a condition called Retinopathy of Prematurity (ROP). In ROP, the tiny blood vessels in the retina (the light-sensitive part at the back of the eye) grow abnormally. If this abnormal growth isn't controlled, it can lead to serious problems like the retina detaching, which can cause permanent blindness. Currently, if ROP becomes severe, doctors might perform laser surgery or give injections into the eye to try and save the baby's vision. While these treatments are often effective, they are expensive and can have side effects.

This study is exploring whether a medicine called propranolol could be a gentler and safer way to prevent severe ROP. Propranolol is a medicine that has been used for many years, even in babies, for other heart conditions and a skin condition called hemangioma. Small studies have hinted that it might be able to stop ROP from getting to the stage where surgery or injections are needed. This trial aims to find out if giving this medicine by mouth to very premature babies can reduce the risk of severe ROP.

Because severe ROP is not very common, this study needs to involve many hospitals and a larger number of babies. This will help doctors understand for sure whether propranolol is effective and safe as a preventative treatment for ROP. The goal is to find a better way to protect the eyesight of these vulnerable premature infants.

Key takeaways

This study investigates if oral propranolol can prevent severe ROP in very premature babies.
ROP is a serious eye condition that can lead to blindness if untreated.
Current ROP treatments include laser surgery or eye injections, which have risks.
Propranolol is a widely used medicine, given by mouth, for other conditions.
The study involves comparing propranolol to a dummy medicine (placebo).
Participation is voluntary, and babies receive close monitoring and standard care.

Who may be eligible?

This study is looking for very premature babies to take part. To be considered, a baby must have been born before 28 weeks of pregnancy and weighed less than 1250 grams at birth. They also need to be at least 5 weeks old when the study drug would start, and their age from conception (gestational age) should be between 31 and almost 37 weeks.

Critically, a baby must already show early signs of ROP (stage 1 or 2) when an eye doctor examines them, but it shouldn't have progressed to the most severe stage requiring immediate treatment. Parents or legal guardians will also need to give their permission for their baby to join the study.

Babies would not be able to join if their ROP is already very severe, or if they have certain serious medical conditions or eye problems that would make it unsafe or unsuitable for them to take the study medicine. This includes certain heart conditions, severe kidney or liver problems, or if they are already taking certain other medications that would interfere with propranolol.

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 before 28 weeks of pregnancy?
Did your baby weigh less than 1250 grams at birth?
Is your baby currently between 5 and about 15 weeks old?
Has an eye doctor found early signs of ROP (stage 1 or 2) in your baby's eyes?
Does your baby NOT have severe ROP (stage 3 or higher) requiring immediate treatment?
Does your baby NOT have a serious heart, kidney, or liver condition?

Answer every question to see your result.

What does participation involve?

If your baby is eligible and you agree for them to take part, they would be assigned by chance to receive either the study medicine, propranolol, or a placebo (a dummy medicine that looks the same but contains no active drug). You wouldn't know which one your baby is receiving, nor would the doctors initially. The medicine would be given by mouth. Regularly, your baby would have eye check-ups with a specialist doctor to monitor the ROP.

Beyond routine care, specific details about hospital visits, exact duration of medication, and follow-up beyond the treatment period would be explained thoroughly by the study team. The total duration of your baby's involvement will depend on how long the medication is given and how often follow-up checks are needed, which will be explained to you in detail.

Potential risks and benefits

Participating in this study might offer a potential benefit if propranolol proves to be effective in preventing severe ROP, potentially reducing the need for more invasive eye treatments for your baby. However, there are also potential risks, as with any medicine. Propranolol can have side effects, which the study team will explain carefully. Your baby will be closely monitored for any reactions or problems. Choosing to participate is entirely voluntary, and you are free to withdraw your baby from the study at any time, for any reason, without it affecting their medical care.

Locations (3)

University Hospital Tübingen
Verified postcode
Tübingen, Germany· Recruiting
University Hospital Zurich
Verified postcode
Zurich, Switzerland· Recruiting
Ankara University School of Medicine Children's Hospital
Verified postcode
Ankara, Turkey (Türkiye)· Recruiting

Common questions

What is ROP?

ROP, or Retinopathy of Prematurity, is an eye condition that can affect babies born very early. It involves abnormal growth of blood vessels in the eye, which can sometimes lead to vision problems or even blindness if not treated.

What is propranolol?

Propranolol is a medicine that has been used for many years to treat conditions like high blood pressure and certain heart problems. It's also used in babies for a skin condition called hemangioma. In this study, we're seeing if it can help prevent severe ROP.

Will my baby definitely get the active medicine?

No, your baby will be randomly assigned to receive either propranolol or a placebo (a dummy medicine) as part of the study. This helps researchers fairly compare the effects of the actual medicine.

What happens if my baby's ROP gets worse during the study?

All babies in the study will have regular eye checks. If your baby's ROP gets worse and needs standard treatment like surgery or injections, they will receive that care immediately, regardless of whether they are on the study medicine or placebo.

Will participating affect my baby's usual care?

No, joining the study will not affect the high standard of care your baby already receives. The study treatments are in addition to, not instead of, their usual medical attention.

How to find out more

Dirk Bassler, M.D.

dirk.bassler@usz.ch +41 44 255 53 40 Official trial record

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