About this trial
Extremely premature infants are at risk of developing a potentially blinding eye disease, called retinopathy of prematurity (ROP). Currently available treatment, consisting of laser surgery or injection of drugs into the eye balls, may prevent most but not all cases of permanent ROP-mediated blindness. Both types of treatment are associated with significant costs and side effects.
An orally administered drug commonly used to treat hypertension, propranolol, may be effective in halting progression of ROP to severe stages, as suggested by preliminary data from small studies. As severe (threshold) ROP is an overall rare disease, the effectiveness of propranolol in combating ROP can only be assessed in a large, multicenter randomized controlled trial involving hospitals caring for extremely preterm infants of diverse origin.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Propranolol
- Placebo
Treatment groups
Sponsors and collaborators
University of Zurich
Lead sponsor
Ankara University
Collaborator
University Hospital Tuebingen
Collaborator