For prevention studies, the primary objective is to determine whether early administration of beta-blockers reduces the incidence and severity of ROP in preterm infants compared with placebo or no treatment. We will classify studies as prevention trials if they enrolled preterm infants without ROP or with confirmed stage 1 (zone I) or stage 2 ROP without plus disease (zone II) with the aim of avoiding development of ROP (primary prophylaxis) or progression of ROP towards more severe stages (secondary prophylaxis) (i.e. stage 2 with plus disease, stage 3 with or without plus disease, stage 4 and stage 5).
For treatment studies, the primary objective of this review is to determine the effects of beta-blockers compared with placebo or no treatment on severe visual impairment or blindness and on structural outcomes. We will classify studies as treatment trials if they enrolled preterm infants with at least prethreshold ROP.
For both types of trials, the secondary objective is to determine the safety of beta-blocker administration.
For both types of trials, we are planning to perform subgroup analyses to consider whether GA (extremely preterm neonates < 28 weeks' GA, very preterm neonates 29 to 31 weeks' GA, preterm infants 32 to 36 weeks' GA) or specific beta-blocking agents influence the outcomes of interventions.
This is a protocol.