The Effect of Phosphodiesterase Type 5 Inhibitors on the Development of Retinopathy of Prematurity in Imam Khomeini Hospital's, Ahvaz, Iran Preterm Infants: A Randomized Clinical Trial
Masoud Dehdashtian
Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Mostafa Feghhi
Department of Ophthalmology, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Mohammad Reza Aramesh
Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Arash Malakian
Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Mohammad Reza Abbaspour
Department of Pharmacy, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Seyed Mohammad Hassan Altayeb *
Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
Ali Khosrevi
Department of Pediatrics, Imam Khomeini Hospital, Ahvaz Jundishapur University of Medical Sciences, Ahvaz, Iran.
*Author to whom correspondence should be addressed.
Abstract
Background: Retinopathy of prematurity (ROP) affects premature infants, and it is characterized by the development of vascular proliferation due to hyperoxia, down regulation of Vascular endothelial growth factor(VEGF) and death of endothelial cells. We hypothesized that inhibition of Phosphodiesterase 5 enzyme suppresses retinal vasoconstriction and prevent ROP.
Study Design: 109 newborns with respiratory distress syndrome treated with oxygen with early gestational age (GA) ≤30 weeks and birth weight (BW) ≤1500 g were randomized into two groups, 52 patients in sildenafil and 50 patients in placebo group were studied, Group sildenafil (as case group) and placebo Group (as control group), sildenafil was administered via nasogastric tube. Occurrence of ROP phase 1 as primary outcome and stage 2-5 ROP, duration of mechanical ventilation, oxygen therapy and duration of hospitalization as secondary outcomes were assessed.
Results: There was no differences between the two group in demographic characteristics. ROP phase 1 was seen in 11(22%) and 7(14%) of placebo and interventional group, respectively. Stage 3 ROP was not seen in any of the patients.
Conclusion: Sildenafil therapy did not affect ROP development in premature infants treated with oxygen. May be due to our exclusion criteria (BW less than 1000g) and this fact that there is a high incidence of ROP in extremely low birth weight neonates, we didn’t find any significant difference. More studies with larger population and expanded criteria are needed to find the effect of sildenafil on ROP.
Keywords: Retinopathy of prematurity, premature infants, sildenafil, oxygen therapy, respiratory distress syndrome