Reduction of retinopathy of prematurity in extremely low gestational age newborns treated with recombinant human Cu/Zn superoxide dismutase.
BACKGROUND
Reactive oxygen species have been implicated in the pathogenesis of retinopathy of prematurity (ROP). Extremely low gestational age (GA) newborns (ELGANs) have the highest risk of ROP and might benefit most from treatment with antioxidants.


OBJECTIVE
To determine whether recombinant human Cu/Zn superoxide dismutase (rhSOD) decreases the incidence or severity of ROP in ELGANs.


METHODS
A previous multicenter trial of intratracheal rhSOD for prevention of bronchopulmonary dysplasia randomized 302 preterm infants to receive intratracheal rhSOD or placebo at birth and every 48 h for 1 month. An analysis of the incidence and severity of ROP was performed in ELGANs.


RESULTS
The risk of ROP increased with decreasing GA. Within the entire cohort, no significant differences in ROP were found in the placebo versus rhSOD groups. Subgroup analysis on infants born at <26 weeks (n = 72) revealed a 22% reduction in ROP from 85% (placebo) to 66% (rhSOD) (p = 0.06). In subjects born at <25 weeks (n = 24), ROP was reduced by 53% from 85% (placebo) to 40% (rhSOD) (p = 0.03). ROP severity above stage 2 was found in 42% of placebo-treated infants but only 25% of rhSOD-treated subjects with ROP.


CONCLUSIONS
This post hoc analysis suggests that rhSOD reduces the risk of developing ROP in ELGANs, although further studies are required to confirm this observation.
Department of Newborn Medicine, Brigham and Women's Hospital, Boston, MA 02115, USA. rparad@partners.org
Richard B
RB
Parad
Elizabeth N
EN
Allred
Warren N
WN
Rosenfeld
Jonathan M
JM
Davis
D000975:Antioxidants / Q000627:therapeutic use*; D001997:Bronchopulmonary Dysplasia / Q000517:prevention & control; D004311:Double-Blind Method; D005865:Gestational Age; D006801:Humans; D015994:Incidence; D007231:Infant, Newborn; D007234:Infant, Premature; D016015:Logistic Models; D010102:Oxygen Inhalation Therapy / Q000009:adverse effects*; D011994:Recombinant Proteins / Q000627:therapeutic use; D012178:Retinopathy of Prematurity / Q000175:diagnosis / Q000453:epidemiology / Q000517:prevention & control*; D012720:Severity of Illness Index; D013482:Superoxide Dismutase / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome; D014481:United States
D000975:Antioxidants; D011994:Recombinant Proteins; D013482:Superoxide Dismutase