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Randomized clinical trial of surfactant prophylaxis in retinopathy of prematurity
J M Holmes1, C M Cronin, P Squires
1Department of Ophthalmology, Loyola University, Chicago, Maywood, Ill 60153.
Insights
Prophylactic lung surfactant did not significantly impact retinopathy of prematurity (ROP) incidence or severity in premature infants. This study found no link between surfactant treatment and ROP outcomes in a randomized trial.
Area of Science:
- Neonatal Medicine
- Ophthalmology
- Pediatric Critical Care
Background:
- Neonatal respiratory distress syndrome (NRDS) is managed with prophylactic lung surfactant.
- The impact of prophylactic lung surfactant on retinopathy of prematurity (ROP) remains debated.
- ROP is a significant concern in premature infants.
Purpose of the Study:
- To investigate the effect of prophylactic lung surfactant on the incidence and severity of ROP.
- To clarify the relationship between surfactant administration and ROP development in preterm infants.
Main Methods:
- A double-masked, multicenter randomized trial involving 64 infants (gestational age 23-32 weeks).
- Infants were randomized to receive intratracheal bovine surfactant prophylaxis or air control.
- Retrospective analysis of ROP data from 48 surviving infants with complete ophthalmologic examinations.
Main Results:
- ROP developed in 83% of the surfactant group (19/23) versus 60% of the control group (15/25), P = .1.
- No significant difference was observed in the worst stage of ROP between the surfactant and control groups (P = .4).
- Retrospective analysis indicated no significant effect of surfactant on ROP incidence or severity.
Conclusions:
- Prophylactic lung surfactant does not appear to significantly affect the incidence or severity of retinopathy of prematurity.
- Further research may be needed to fully elucidate the complex interplay between surfactant therapy and ROP.
- Clinical practice regarding surfactant use in relation to ROP requires careful consideration of current evidence.
Abstract:
Prophylactic lung surfactant is commonly used to reduce the severity of neonatal respiratory distress syndrome in premature infants. There is disagreement in the literature regarding the effect of prophylactic lung surfactant on the incidence of retinopathy of prematurity (ROP). Sixty-four infants, gestational age 23 to 32 weeks, birth weight 610 to 1250 g, were randomized to receive either intratracheal bovine surfactant prophylaxis or air control, at our institution, as part of a national double-masked multicenter trial. Forty-eight of these infants survived and underwent complete ophthalmologic examinations by a single masked examiner. ROP data were gathered retrospectively. ROP developed in 19 of the 23 (83%) who received surfactant and 15 of the 25 (60%) controls (P = .1). Analysis of the worst stage of ROP for each infant also revealed no difference between the surfactant and control groups (P = .4). Our retrospective analysis of ROP data in a prospective double-masked randomized study revealed no significant effect of surfactant on the incidence or severity of ROP.