Could a common heart pill save Preemies' eyesight?
NCT ID NCT03083431
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether an oral blood pressure drug, propranolol, can prevent severe eye disease (retinopathy of prematurity) in extremely premature infants. About 276 babies born before 28 weeks and weighing under 1250 grams will receive either propranolol or a placebo. The goal is to see if the drug reduces the need for invasive eye treatments like laser surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 276 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Sep 2022
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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5 to 15 weeks
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria: * Preterm infant born before 28 week's gestation * Birth weight below 1250 g * At least 5 weeks of age (at randomisation) * PMA 310/7 - 36 6/7 weeks * Ophthalmoscopic evidence of incipient ROP (stage 1 or 2, with or without plus disease in any zone) * Written informed consent by parents or legal guardian, according to national requirements Exclusion Criteria: * ROP stage ≥ 3, AP-ROP or suspected AP-ROP, or any other ROP requiring an intervention (study endpoint already reached). * Conditions that indicate open label propranolol such as: thyrotoxicosis, arterial hypertension or certain heart diseases (such as tetralogy of Fallot, paroxysmal supraventricular tachycardia, or long QT syndrome) etc. * Major congenital malformations or known chromosomal anomalies * Colobomas and other eye malformations * PHACE syndrome (posterior fossa anomalies, large infantile hemangiomas of the face, neck, and/or scalp, arterial lesions, cardiac abnormalities/coarctation of the aorta, eye anomalies) (risk of cerebrovascular complications) * Very large hemangioma (risk of hyperkalemia), as judged by the attending physician * Medication of the infant with rifampicin or phenobarbitone (enhanced metabolic clearance) * Chronic kidney impairment (serum creatinine \> 1.3 mg/dl \[115 μmol/L\]) * Severe liver dysfunction (ALT (GPT) \> 900 U/L) * Known hypersensitivity to propranolol or any of the excipients (see 6.3.1.) * Prinzmetal's angina, Raynaud's phenomenon (severe peripheral arterial circulatory disturbance), or pheochromocytoma (contraindications for propranolol in adults, not occurring in newborn infants) * Any circumstances that make the investigator believe that participation in the study leads to exceptional medical or organizational problems for the patient * Conditions that prohibit propranolol therapy such as: Atrio-ventricular block grade 2 or 3 hypertrophic cardiomyopathy, sinoatrial block, uncontrolled heart failure or cardiogenic shock, bronchial asthma * Medication of the infant or the mother if breastfeeding with clonidine, reserpine, angiotensin-converting enzyme inhibitors, angiotensin-receptor antagonists (contraindicated in preterm infants) or antiarrhythmic drugs including amiodarone, propafenone, lidocaine, digoxin/digitoxin, quinidine, verapamil, diltiazem, bepridil (pharmacodynamic interaction)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
3 sites in 3 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Ankara University School of Medicine Children's Hospital
RECRUITINGAnkara, Ankara, 06590, Turkey (Türkiye)
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University Hospital Tübingen
RECRUITINGTübingen, Baden-Wurttemberg, 72076, Germany
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University Hospital Zurich
RECRUITINGZurich, Canton of Zurich, 8091, Switzerland
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can music soothe premature babies during painful eye exams?
- Oxygen drops during eye injections in preterm babies: a hidden risk?
- Tiny doses of avastin tested against laser for preemie eye disease
- Could steroid eye drops save premature Babies' sight?
- Premature Babies' vision tracked years after ROP treatment
- Could Omega-3 levels predict eye problems in preemies?