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Study on Oral Propranolol for Preventing Severe Retinopathy in Premature Infants

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition called retinopathy of prematurity, which affects the eyes of infants born very early. The study is investigating the use of a medication called propranolol hydrochloride, which is given as an oral solution. The purpose of the study is to see if this medication can safely and effectively reduce the risk of developing a severe form of this eye condition in extremely preterm infants.

During the study, infants who are born before 28 weeks of pregnancy and have a birth weight below 1250 grams will be given either the medication or a placebo. The infants will be monitored over a period to see if the medication helps in preventing the progression of retinopathy of prematurity to a more severe stage. The study aims to find out if the infants can survive without developing severe retinopathy of prematurity, which might otherwise require treatments like laser surgery or injections into the eye.

The study will follow the infants for a certain period to observe the effects of the medication. The goal is to determine if propranolol hydrochloride can help in reducing the risk of severe eye problems in these very young infants, potentially improving their long-term eye health and vision outcomes.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the infant must meet specific criteria. These include being born before 28 weeks of pregnancy, having a birth weight below 1250 grams, being alive at 5 weeks of age, and having a postmenstrual age between 31 weeks and 36 weeks and 6 days.
The infant must show early signs of a condition called retinopathy of prematurity (ROP), which affects the eyes. This is determined through an eye examination.
Written informed consent must be provided by the parents or legal guardian, allowing the use of medical data for study purposes.
Step 2
Medication administration
The infant will receive a medication called propranolol hydrochloride orally. This medication is intended to help prevent the progression of ROP.
The dosage, frequency, and duration of administration will be determined by the study protocol and the medical team overseeing the trial.
Step 3
Monitoring and assessments
Throughout the trial, the infant will undergo regular monitoring and assessments to evaluate the safety and effectiveness of the medication.
These assessments will include regular eye examinations to check for any changes in the condition of the eyes.
Step 4
Completion of the trial
The trial is expected to continue until December 31, 2025. During this time, the infant will be closely monitored to ensure their safety and to gather data on the effectiveness of the treatment.
The primary goal is to determine if the infant can survive without developing severe ROP, which may require further treatment.

Who can join the trial?

6 criteria

Preterm infant born before 28 weeks of pregnancy.
Birth weight below 1250 grams.
Infant must be alive at 5 weeks of age.
Postmenstrual age between 31 weeks and 0 days to 36 weeks and 6 days.
(Postmenstrual age is the time from the first day of the mother's last menstrual period to the current date, including the time the baby has been outside the womb.)
Ophthalmoscopic evidence of early signs of retinopathy of prematurity (ROP), which is a condition affecting the eyes.
(This means the baby has been examined and shows early signs of ROP, specifically stage 1 or 2, with or without additional eye changes known as "plus disease.")
Parents or legal guardian must provide written informed consent.
(This means they agree in writing to allow the baby to participate in the study and understand that medical data will be used for research purposes.)

Who cannot join the trial?

8 criteria

Patients who have any other serious health conditions that could interfere with the study.
Patients who are currently taking medications that might interact with the study drug, **propranolol**.
Patients who have had an allergic reaction to **propranolol** or similar medications in the past.
Patients who have a history of heart problems, such as a slow heart rate or heart block, which is a condition where the heart beats irregularly.
Patients with very low blood pressure, as **propranolol** can lower blood pressure further.
Patients with asthma or other breathing problems, since **propranolol** can make these conditions worse.
Patients who have severe kidney or liver disease, as these organs are important for processing medications.
Patients who are participating in another clinical trial at the same time.

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Verified sites

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Charite Universitaetsmedizin Berlin KöR
Berlin, Germany
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Medizinische Hochschule Hannover
Hanover, Germany
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Technische Universitaet Dresden
Dresden, Germany

Trial locations

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Investigated drugs

Propranolol is a medication that is being tested in this clinical trial. It is given by mouth and is usually used to treat high blood pressure and heart-related issues. In this study, it is being used to see if it can help prevent a serious eye condition called retinopathy of prematurity in very premature infants. This condition can affect the eyes of babies born too early, and the trial aims to find out if propranolol can safely reduce the risk of developing this condition.

Propranolol Hydrochloride

What is already known about the treatment

Propranolol – Propranolol is administered orally, meaning it is taken by mouth in the form of a pill or liquid. It is currently being studied in clinical trials to determine its safety and effectiveness in preventing a serious eye condition called retinopathy of prematurity in extremely preterm infants. This medication is primarily used to treat high blood pressure and heart-related issues, but in this trial, it is being explored for its potential to protect the eyes of premature babies. Propranolol works by blocking certain natural chemicals in the body, like adrenaline, which helps to reduce heart rate and blood pressure, and in this context, it may help prevent abnormal blood vessel growth in the eyes. It belongs to a class of drugs known as beta-blockers.

Investigated diseases

Retinopathy of prematurity – Retinopathy of prematurity is a disease that affects the eyes of premature infants. It occurs when abnormal blood vessels grow in the retina, the layer of tissue at the back of the inner eye. This abnormal growth can cause the retina to detach from the back of the eye, potentially leading to vision problems. The disease progresses in stages, from mild changes in the retina to more severe forms that can result in retinal detachment. In its early stages, the disease may resolve on its own, but in more advanced stages, it can lead to significant visual impairment. The progression is closely monitored in premature infants to prevent severe outcomes.