Lack of efficacy of light reduction in preventing retinopathy of prematurity. Light Reduction in Retinopathy of Prematurity (LIGHT-ROP) Cooperative Group. The effects of comfort care on the pain response in preterm infants undergoing screening for retinopathy of prematurity. Light reduction and the electroretinogram of preterm infants. Effect of topical anesthesia and age on pain scores during retinopathy of prematurity screening. Efficacy of topical anesthetics to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Efficacy of sucrose to reduce pain in premature infants during eye examinations for retinopathy of prematurity. Controlled trial of D-penicillamine to prevent retinopathy of prematurity. A controlled clinical trial of light and retinopathy of prematurity. Effect of sustained pharmacologic vitamin E levels on incidence and severity of retinopathy of prematurity: a controlled clinical trial.
Hospital-nursery lighting has been suggested as a factor in causing retinopathy of prematurity. Despite ongoing debate, a causal relation has not been established.
                We conducted a prospective, randomized, multicenter study of the effects of light reduction on 409 premature infants with birth weights of less than 1251 g and gestational ages of less than 31 weeks. Two hundred five infants were exposed to reduced light, and 204 to typical nursery lighting. The amount of light reaching the infants' eyes was reduced within 24 hours after birth by placing goggles on the infants that reduced visible-light exposure by 97 percent and ultraviolet-light exposure by 100 percent. The babies wore the goggles until 31 weeks' postconceptional age or 4 weeks after birth, whichever was longer. Once the goggles were removed, ophthalmologists masked to the treatment assignments assessed the infants for retinopathy of prematurity at least biweekly for up to 13 weeks.
                There were 188 infants in the group that wore goggles and 173 in the control group who survived and were available for follow-up. The mean birth weights were 906 g in the goggles group and 914 g in the control group; the mean gestational ages were 27.4 weeks and 27.2 weeks, respectively. The mean ambient-light level adjacent to the infants' faces was 399 lux for the goggles group and 447 lux for the control group. Retinopathy of prematurity was diagnosed in 102 infants (54 percent) in the goggles group and 100 (58 percent) in the control group (relative risk, 0.9; 95 percent confidence interval, 0.8 to 1.1; P=0.50).
                A reduction in ambient-light exposure does not alter the incidence of retinopathy of prematurity. The aim of the study was to determine if pain and distress during the retinopathy of prematurity (ROP) screening examination could be ameliorated by providing comfort care.
                This study was a prospective, randomized, controlled trial of 30 stable preterm infants who underwent initial ROP screening examinations. Fourteen study infants were swaddled, held, and given 24% sucrose solution during the examination. Sixteen controls were examined while lying in their cribs. Vital signs (i.e., pulse rate, respiratory rate, and oxygen saturation), crying time, and time for the vital signs to return to baseline values were recorded at different times during the examination.
                The vital signs did not vary significantly between the two groups. The participants in the control group had a trend of longer crying time, but this trend did not reach a level of statistical significance. In addition, The time required for the vital signs to return to their baseline values did not vary significantly.
                ROP screening is very distressful for preterm infants. The routine use of comfort care to reduce pain during the examination could not be supported by this study. To examine the effects of light on retinal development and function in preterm infants as measured by the electroretinogram (ERG). Secondary outcomes included visual acuity testing, the incidence of retinopathy of prematurity, and general wellbeing, reflected in feeding tolerance, rate of weight gain, and length of hospital stay.
                Eligibility criteria for enrollment were birthweight < or = 1250 g and gestational age < or = 31 weeks. Sixty one infants were randomly allocated by 6 hours after birth to a control or treatment group which wore 97% light filtering goggles for a minimum of four weeks or until the infant reached 31 weeks postmenstrual age.
                There were no significant differences between the two groups in the numbers of electroretinograms performed at 36 weeks of postmenstrual age. Although the sample size was not large enough to exclude clinically important differences in secondary outcomes, no significant differences were observed between the groups in visual acuity testing at 4-6 months corrected age, incidence of retinopathy of prematurity, weight gain, or length of stay.
                These data support the safety and feasibility of this intervention. A much larger study will be needed to determine whether light reduction to the eyes of very low birthweight infants will reduce the incidence of retinopathy of prematurity or enhance general well-being. The efficacy of topical anesthesia during retinopathy of prematurity (ROP) screening has been a controversial issue. To determine the efficacy of proparacaine eye drops (0.5%), we compared the Premature Infant Pain Profile (PIPP) scores in 40 preterm infants undergoing ROP screening.
                Prospective randomized double masked cross-over clinical trial. The study was conducted in the neonatal intensive units for infants undergoing routine ROP screening exams. Baseline PIPP scores and post-examination PIPP scores at 1 and 5 min were compared for: (1) those receiving saline vs proparacaine eye drops (2) first ROP screening vs second ROP screening, regardless of the type of eye drops used. Wilcoxon signed-ranks test was used to pair pain scores.
                Forty preterm infants were included in the study. Mean gestational age (GA) at first and second examinations was 33.3 and 35.3 weeks, respectively. Proparacaine use significantly lowered mean PIPP scores (P=0.027) and delta scores (P=0.013) at 1 min after examination, but there was no difference at 5 min after examination. Second examinations showed significantly lower mean PIPP scores after examination (1 min (P=0.003) and 5 min (P=0.025)), regardless of the type of drop used.
                Proparacaine eye drops offer significant relief of pain that is apparently short lived. Significantly lower PIPP scores at second ROP examinations suggested that infants of older GA may have a greater ability to tolerate ROP screening. We recommend the use of proparacaine eye drops for the short term, immediate relief of pain during ROP screening in preterm infants of lesser GA. Eye examinations for retinopathy of prematurity (ROP) are stressful and probably painful, but many ophthalmologists do not apply topical anesthetics because their efficacy in reducing pain has not been established.
                To evaluate the potential benefits of topical anesthetic eye drops in reducing pain during neonatal eye examination for ROP.
                Neonates born at < or =30 weeks' gestation and expected to have at least 2 examinations for ROP were included. Patients were randomly assigned to receive either proparacaine HCl ophthalmic solution 0.5% or NaCl 0.9% (saline) eye drops prior to an eye examination. In a subsequent examination, each patient received the alternate treatment. Eye drops were prepared in the pharmacy in identical tuberculin syringes, and physicians, nurses, and pharmacists were blinded to the treatment given. Pain was measured using a scoring system with both physical and physiologic measures of pain (Premature Infant Pain Profile [PIPP], possible range 1-21), which has been validated in preterm infants. PIPP scoring was performed simultaneously by 2 nurses: 1 and 5 minutes before and after the eye examination and during initial placement of the eye speculum. The same ophthalmologist performed all examinations.
                Twenty-two patients were studied, with 11 infants receiving proparacaine and 11 receiving saline as the first treatment. Crossover was performed with a median of 17.5 days between treatments. Patients experienced significantly less pain at speculum insertion with proparacaine than with saline (paired difference -2.5 +/- 3.4; p = 0.001).
                Topical anesthetic pretreatment reduces the pain response to eye examination for ROP and should become routine practice. Because this is not effective in all infants, additional measures to reduce pain should be taken. Eye examinations for retinopathy of prematurity (ROP) are painful to the neonate. The use of topical anesthetic for eye examinations to evaluate ROP is routine in our neonatal intensive care unit (NICU), but does not completely suppress painful responses. Sweet solutions have been shown to reduce procedural pain in newborns.
                To examine whether the addition of sucrose 24% to topical anesthetic improves procedural pain control during the ROP eye examination.
                Neonates born at < or = 30 weeks' gestation were included in this placebo-controlled, double-blind, crossover study. Patients were randomly assigned to receive treatment with either proparacaine HCl ophthalmic solution 0.5% plus 2 mL of sucrose 24% or proparacaine HCl ophthalmic solution 0.5% plus 2 mL of sterile water (placebo) prior to an eye examination. In a subsequent eye examination, each patient received the alternate treatment. Oral sucrose and sterile water were prepared in the pharmacy in identical syringes, and physicians, nurses, and pharmacists in the NICU were blinded to the treatment given. Pain was measured using the Premature Infant Pain Profile (PIPP) scoring system, which measures both physical and physiologic measures of pain, and the scores were simultaneously assessed by 2 study nurses. PIPP scores were recorded 1 and 5 minutes before and after the eye examination and during initial placement of the eye speculum. The same ophthalmologist performed all eye examinations. Several different definitions of a pain response were investigated.
                Twenty-three infants were studied, with 12 receiving sucrose and 11 receiving placebo as the first treatment. For 3 of the 5 definitions of pain response, patients experienced significantly less pain at speculum insertion with sucrose than with placebo. After the ROP examination, pain responses were similar with either sucrose or placebo.
                Oral sucrose may reduce the immediate pain response in premature infants undergoing eye examination for ROP. 204 infants with birthweights between 751 and 2000 g and 26-35 weeks gestational age (100 treated and 104 control subjects) were enrolled in a prospective controlled trial of the effectiveness of D-penicillamine (DPA) in the prevention of retinopathy of prematurity (ROP). The two groups did not differ significantly in gestational age, birth weight, Apgar scores, the time of exposure to oxygen and in the incidence of PDA or in the number of exchange transfusions and RBTs. Of the treated infants 29, and of the control infants 34 died before the tenth week of life. These cases were not included in further analysis. Patients were subsequently examined and assessed by two ophthalmologists independently, who did not know which babies were receiving DPA. Six of the 70 surviving control infants and none of the 71 surviving treated infants had ROP stage II or graver. The results suggested that ROP may effectively be prevented with DPA in very low-birth-weight-infants, and that the drug has no serious adverse effects during the neonatal period. Bright continuous light has been implicated in the pathogenesis of retinopathy of prematurity. To investigate the influence of light on the incidence and severity of retinopathy of prematurity, we enrolled 127 preterm infants (birth weight < or = 1,500 g; gestational age < or = 32 weeks) in a controlled clinical study. Randomization was done separately for three birth-weight groups (< 1,000 g; 1,000 to 1,249 g; 1,250 to 1,500 g). The babies' eyes were patched all day and night from birth to a gestational age of 35 weeks. The infants in the control group were exposed to cycled lighting conditions (that is, reduced light level during the night). Of 62 infants with patched eyes, 26 (42%) developed retinopathy of prematurity. In the control group, 25 of 65 infants (39%) showed retinopathy of prematurity (P = .596). There were also no statistically significant differences in the incidences of retinopathy of prematurity in the birth-weight subgroups or in the severity of retinopathy of prematurity. Thus, patching of the eyes from birth to 35 weeks of postconceptional age does not decrease the risk of retinopathy of prematurity in preterm infants when compared to a control group exposed to cycled lighting conditions. The incidence and severity of retinopathy of prematurity (ROP) as affected by vitamin E prophylaxis at pharmacologic serum levels (5 mg/dl) were evaluated in a double-masked clinical trial of infants with a birth weight less than or equal to 2000 gm or a gestational age less than or equal to 36 weeks. The infants were enrolled by age 5 days and randomly assigned to receive parenterally administered, and later orally administered, free alpha-tocopherol (vitamin E) or its placebo. Study medication was continued until retinal vascularization was complete or active ROP had subsided, except in infants with a diagnosis of severe disease, in whom vitamin E was substituted for study medication. Acute ROP data were collected on 755 infants. Logistic regression analysis, with control for immaturity, oxygen exposure, and other illness risk factors, showed a decrease in incidence of ROP in vitamin E-treated infants (p = 0.003, all infants; p = 0.035, infants weighing less than or equal to 1500 gm at birth). Among the 424 infants weighing less than or equal to 1500 gm at birth, the age at enrollment influenced treatment effect (age day 0 to 1, p = 0.006 (n = 288) vs age day 2 to 5, p greater than 0.1 (n = 136]. Overall, 77.6% of infants with ROP had mild disease. Moderate to severe ROP was confined to infants weighing greater than or equal to 1500 gm at birth (25 given placebo, 25 given vitamin E), with progression to severe disease in nine placebo-treated versus three vitamin E-treated infants (p = 0.048). The incidence of severe ROP per se was not significantly decreased (all birth weights, p = 0.086; less than or equal to 1500 gm birth weight, p = 0.080); the sample size was too small, however, to assess this end point adequately. An increased incidence of sepsis and late-onset necrotizing enterocolitis was found among vitamin E-treated infants weighing less than or equal to 1500 gm at birth who received study medication for greater than or equal to 8 days (p = 0.006). Because most ROP is mild in degree and regresses completely, the risk/benefit ratio of pharmacologic prophylaxis for ROP is unfavorable. Treatment of moderate and severe ROP with vitamin E above physiologic serum levels (greater than 3 mg/dl) appears promising and should be further investigated. The interpretation of cicatricial outcome was confounded by the small number of patients involved and by subsequent treatment of severe ROP in placebo-treated infants with vitamin E.
Decreasing retinal ambient light exposure in premature infants is very unlikely to reduce the incidence of ROP.