Abstract
IMPORTANCE: Although screening examinations for retinopathy of prematurity (ROP) prevent blindness, they are physiologically stressful for infants. Photosensitivity during mydriasis may contribute to postexamination stress, and reducing light stimulation may make infants more comfortable. OBJECTIVE: To determine the effect of a phototherapy mask worn during mydriasis on infant stress in the 12-hour period following ROP screening. DESIGN, SETTING, AND PARTICIPANTS: The Effect of Eyemasks on Neonatal Stress Following Dilated Retinal Examination (MASK-ROP) randomized clinical trial with patient recruitment from April 2016 to June 2017 at neonatal intensive care units at St Michael's Hospital and Sunnybrook Health Sciences Center in Toronto, Ontario, Canada. A consecutive series of infants with birth weight of less than 1500 g and/or gestational age of less than 32 weeks undergoing their first ROP screening were analyzed beginning in July 2017. Analysis was intention to treat. INTERVENTIONS: Patients were randomized to wear a phototherapy mask for a minimum of 4 hours after dilating drop instillation in addition to standard comfort measures. MAIN OUTCOMES AND MEASURES: Number of desaturation, bradycardic, or apneic events during the 12-hour postexamination period. RESULTS: Of 51 infants who were examined, 28 (54.9%) were randomized to the treatment group (ie, used a mask) and 23 (45.1%) to the control group. Overall, 10 (35.7%) and 13 infants (56.5%) received ventilator support at the time of examination in the treatment and control groups, respectively. The mean (SD) gestational age was 27.9 (2.4) weeks, 32 (63%) were boys, and the mean (SD) birth weight was 1058.6 (312.0) g. The number of all stressful events were lower in the treatment group compared with controls in the 12-hour postexamination period, adjusted for events prior to examination and ventilation status (mean [95% CI] events, 1.0 [0.6-1.8] vs 1.7 [1.0-1.7]; rate ratio [RR], 0.57; 95% CI, 0.3-1.2; P = .12). Risk factors associated with increased stress included younger gestational age (RR, 1.32; 95% CI, 1.2-1.5 per week), lower birth weight (RR, 1.39; 95% CI, 1.2-1.5 per 100 g), ventilator support around the time of examination (RR, 2.67; 95% CI, 1.3-5.6), intraventricular hemorrhage (RR, 3.78; 95% CI, 1.9-7.3), and hyponatremia (RR, 3.42; 95% CI, 1.8-6.6). No adverse events occurred while using eye masks. CONCLUSIONS AND RELEVANCE: This randomized clinical trial found that light sensitivity may play a role in stress observed in the late postexamination period. However, unequal distribution of infants receiving ventilator support placed certain neonates at higher risk of stress, and the clinical significance of this intervention's benefit could not be concluded with confidence. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03824782.