ABSTRACT
OBJECTIVE: Mydriatic eye drops used for retinopathy of prematurity (ROP) examination can cause systemic effects, and there are case reports of serious adverse effects in the literature. In this prospective study, we aimed to evaluate the early hemodynamic effects of mydriatic eye drops to understand the possible mechanisms of adverse effects. STUDY DESIGN: Between December 2018 and March 2019, preterm babies less than 32 gestational weeks and who underwent ophthalmologic examination in our unit were included. The vital signs (heart rate, respiratory rate, oxygen saturation [SpO2], and blood pressure values), cerebral and mesenteric tissue saturation by near-infrared spectroscopy (NIRS), and left ventricular functions of infants were recorded before and after applying mydriatic eye drops (2.5% phenylephrine and 0.5% tropicamide). The data were compared statistically. Strict adherence to prevent systemic absorption of the eye drops was applied. RESULTS: Thirty-two mydriasis procedures were evaluated in 26 patients. The mean gestational age was 28.5 ± 1.7 weeks, and the mean birth weight was 943 ± 233 g. There were no significant differences in terms of vital signs of infants including heart rate, blood pressure, and oxygen saturation [SpO2] levels before and after eye-drop application. In addition, NIRS values showed no significant differences between before and after measurements. No significant differences were detected at echocardiographic evaluation performed before and after mydriatic administration. No adverse reaction was observed in the study population during the study. CONCLUSION: This is the first study that evaluated the early hemodynamic effects of mydriatic eye drops used for ROP screening by vital signs, NIRS, and echocardiographic evaluation. Mydriatic eye drops have no significant effect on early hemodynamic parameters including vital signs, NIRS, and echocardiographic findings in preterm infants. We suggest that a cautious approach for avoiding the systemic absorption of these agents may prevent the possible early systemic effects in this high-risk population. KEY POINTS: · Mydriatic eye drops are commonly used for pupil dilatation before retinopathy of prematurity examination, and there are reports of serious adverse events caused by these drops.. · Due to the adverse events of eye drops, hemodynamic effects of these agents were investigated by clinical findings, near-infrared spectroscopy, and echocardiography.. · No significant early hemodynamic effect was observed so avoiding systemic effects may be prevented with precautions..
ABSTRACT
BACKGROUND: Currently, there is a lack of clear definition for neonatal sepsis. The Pediatric Committee of the European Medicines Agency (EMA) developed consensus criteria to ensure a standardization for neonatal sepsis definition. However, there is no evidence supporting the accuracy of the EMA sepsis criteria in neonatal sepsis diagnosis. The main objective of this study was to evaluate the diagnostic accuracy of EMA sepsis criteria for proven neonatal sepsis. METHODS: A multicenter prospective cohort study was conducted from October 2015 to November 2018. Infants with a gestational age over 34th weeks, diagnosed with clinical sepsis and received antibiotics according to the EMA criteria or experienced neonatologists' opinion were included. Blood culture or multiplex real time-PCR or 16S-rRNA positive infants were accepted as "proven sepsis". The predictive performance of EMA criteria for proven sepsis was evaluated by sensitivity, specificity, accuracy, and area under the curve measures of receiver operator characteristic curves. Data-mining methods were used for further analysis. RESULTS: Among the 245 included infants, the EMA criteria were positive in 97 infants (39.6%), while proven sepsis was diagnosed in 113 infants (46.1%). The sensitivity, specificity, and accuracy of the EMA criteria for proven sepsis were 44.2% (95%CI: 34.9-53.9), 64.4% (95%CI: 55.6-72.5), 55.1% (95%CI: 46.6-59.4) respectively. None of the clinical and laboratory parameters had sufficient performance individually in terms of sensitivity, specificity and accuracy measures. The diagnostic performance was similar when different clinical findings were added to the EMA sepsis criteria or assessment of the score was interpreted in different ways. CONCLUSIONS: Results highlighted that clinician opinion and standard laboratory tests are limited in the neonatal sepsis diagnosis. The EMA criteria also did not efficiently meet the diagnostic accuracy measures for neonatal sepsis. A predictive sepsis definition and rapid bedside point-of care tests are urgently needed.
