AuthorisedTherapeutic exploratory (Phase II)Interventional

Pain Relief at Screening for Retinopathy of Prematurity - The PROPER study

Babies born very early often need regular eye examinations to check for a condition called retinopathy of prematurity (ROP). ROP affects blood vessels in the eye and can cause sight problems if not treated early. To examine the eyes properly, doctors use drops to widen the pupils and a tiny tool to gently hold the eyelids open. Even with local anaesthetic drops, this examination can cause distress and discomfort. The PROPER study is exploring whether adding a gentle sedative medicine called dexmedetomidine helps keep premature babies calm and comfortable during their screening. Doctors will carefully measure the babies' pain scores, heart rates, breathing, and crying times during and after the checks. The goal is to discover the kindest, safest way to carry out these essential eye checks while keeping babies as comfortable as possible in hospital.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

St. Olavs Hospital HF

Enrolment target

Start

22 Jun 2026

Retinopathy of prematurity

What is this study about?

Retinopathy of prematurity (ROP) is an eye condition that can develop in babies born very early. Because their eyes are not fully developed at birth, the blood vessels inside can grow unusually. To protect their eyesight, specialist eye doctors regularly examine these babies in the neonatal unit. While these checks are vital, they can be uncomfortable. Doctors use special eye drops to widen the pupils and a gentle device called an eyelid speculum to keep the eye open during the check. Even though local numbing drops are always used, babies often cry or show signs of stress.

The PROPER clinical study is testing whether a medicine called dexmedetomidine can provide better pain relief and comfort during these eye checks. Dexmedetomidine is a medicine that helps calm the body and relieve pain without stopping normal breathing. Researchers want to see if combining this medicine with standard numbing drops reduces pain more effectively than standard care alone.

During the study, doctors and nurses will closely monitor how the babies react. They will record facial expressions, crying, heart rates, oxygen levels, and how well the babies sleep afterwards. Finding better ways to manage pain in premature babies is very important, as reducing stress supports their overall growth and brain development.

Key takeaways

The PROPER study aims to improve pain relief for premature babies having routine eye checks.
It tests whether a calming medicine (dexmedetomidine) reduces stress during eye examinations.
Babies' comfort, heart rate, oxygen levels, and crying times are closely monitored throughout.
All procedures happen in the neonatal unit during planned checks without extra hospital visits.
Participation is entirely voluntary, and standard NHS neonatal care is guaranteed at all times.

Who may be eligible?

This study is designed for premature babies who are being cared for in a neonatal unit and need routine screening checks for retinopathy of prematurity.

Both baby boys and baby girls who require these eye examinations can be considered. The doctors looking after your baby will check their overall health, age, and medical history to make sure taking part is safe and appropriate for them.

Babies who have certain severe heart conditions, unstable medical problems, or known allergies to the study medicines will not be able to join. Your neonatal team will explain in detail whether your baby meets all the safety criteria.

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.

My baby was born prematurely and is currently in a neonatal unit.
My baby is scheduled to have eye screening for retinopathy of prematurity (ROP).
My baby has not had an allergic reaction to local anaesthetic drops or sedatives.
The neonatal team confirms my baby is medically stable enough to participate.
I am the baby's parent or legal guardian and can give informed consent.

Answer every question to see your result.

What does participation involve?

If your baby joins the study, their eye examinations will take place directly in the neonatal intensive care or special care baby unit, so there are no extra hospital visits.

Before the eye check, your baby will receive their routine eye drops to widen the pupils and numb the surface of the eye. In addition, they will receive the study medicine (dexmedetomidine) or standard treatment via an infusion or injection, as decided by the study plan. A specialist eye doctor will then perform the examination as usual.

During the examination and for a short time afterwards, nurses and doctors will track your baby's comfort using a special pain scoring system for infants. They will also continuously monitor your baby's heart rate, breathing, oxygen levels, and sleep patterns. The study only covers the time around the planned eye checks and does not extend your baby's hospital stay.

Potential risks and benefits

Taking part may help your baby feel calmer and experience less discomfort during their eye check, though this cannot be guaranteed. The findings will also help doctors improve care for other premature babies in the future. As with all medications, there is a risk of side effects; dexmedetomidine can sometimes temporarily lower heart rate or blood pressure, but your baby will be closely monitored by expert neonatal staff throughout. Joining the study is completely voluntary, and choosing not to take part or withdrawing at any point will never affect the standard of care your baby receives.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Norway

Common questions

Why does my baby need eye screening in the first place?

Premature babies are at risk of an eye condition called retinopathy of prematurity (ROP). Regular checks allow doctors to spot any blood vessel changes early and protect your baby's eyesight.

Will my baby feel pain during the eye check?

Numbing eye drops are always used, but holding the eye open and bright lights can still feel uncomfortable. This study is testing extra medication to keep babies even more comfortable.

Is dexmedetomidine safe for premature babies?

Dexmedetomidine is widely used in children and babies to provide calm pain relief. Your baby's vital signs, like breathing and heart rate, will be constantly watched by the medical team.

Will taking part keep my baby in hospital longer?

No. The study activities happen during your baby's already scheduled eye checks in the neonatal unit and will not delay your baby going home.

Can I change my mind later?

Yes. You can withdraw your baby from the study at any time without giving a reason, and your baby's normal medical care will continue as usual.