Ankita Shukla1,2, Christine Sonnie3, Sarah Worley4, Amit Sharma3, Dawn Howard1, Jon Moore2, Ricardo J Rodriguez1, George Hoppe3, Jonathan E Sears3,5. 1. Department of Pediatrics, Division of Neonatology, Cleveland Clinic, Cleveland, Ohio. 2. Department of Pediatrics, Case Western Reserve Institute-Metro Health Medical Center, Cleveland, Ohio. 3. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio. 4. Department of Quantitative Health Sciences, Cleveland Clinic, Cleveland, Ohio. 5. Cellular and Molecular Medicine, Cleveland Clinic, Cleveland, Ohio.
Abstract
Importance: The Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) demonstrated that static low oxygen saturation decreased retinopathy of prematurity (ROP) but increased mortality compared with static high oxygen saturation cohorts. Objective: To compare outcomes of a biphasic oxygen protocol with static targets recommended by SUPPORT. Design, Setting, and Participants: Retrospective cohort study comparing biphasic vs static standards 41 months prior to and 42 months after a change from biphasic to static SUPPORT standards at a level III neonatal intensive care unit (Fairview Hospital, Cleveland, Ohio). The study included infants born at a corrected gestational age (CGA) of 31 weeks or younger or birth weight 1500 g or less. Data were analyzed between August 2010 and July 2017. Interventions: The pre-SUPPORT group underwent biphasic protocol target saturations of 85% to 92% at younger than 34 weeks' CGA and greater than 95% at 34 weeks' CGA or older. The post-SUPPORT group underwent a constant 91% to 95% target. Main Outcomes and Measures: Primary outcome was incidence of type 1 ROP. Secondary outcomes were incidence of any ROP, time to full vascularization, and mortality. Results: Of 596 eligible infants, 562 were included in ophthalmic analysis. Three hundred three patients were boys (54%); 399 were white (71%), 87 were black (15%), and 76 were of other or unknown race/ethnicity (14%). Mean (SD) CGA and birth weight were 29 (2) weeks and 1151 (346) g, respectively. Any ROP overall increased (53 [20%] pre-SUPPORT vs n = 86 [28%] post-SUPPORT; absolute difference, 8%; 95% CI, 1%-15%; odds ratio, 1.6; 95% CI, 1.05-2.3; P = .03). Type 1 ROP increased in the post-SUPPORT era (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; odds ratio, 2.7; 95% CI, 1.05-6.9; P = .03). There was a delay in vascularization in the post-SUPPORT group (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; P = .03). Conclusions and Relevance: Compared with static oxygen standards, biphasic oxygen targets are associated with decreased incidence and severity of ROP without increasing mortality.
Importance: The Surfactant, Positive Pressure, and Pulse Oximetry Randomized Trial (SUPPORT) demonstrated that static low oxygen saturation decreased retinopathy of prematurity (ROP) but increased mortality compared with static high oxygen saturation cohorts. Objective: To compare outcomes of a biphasic oxygen protocol with static targets recommended by SUPPORT. Design, Setting, and Participants: Retrospective cohort study comparing biphasic vs static standards 41 months prior to and 42 months after a change from biphasic to static SUPPORT standards at a level III neonatal intensive care unit (Fairview Hospital, Cleveland, Ohio). The study included infants born at a corrected gestational age (CGA) of 31 weeks or younger or birth weight 1500 g or less. Data were analyzed between August 2010 and July 2017. Interventions: The pre-SUPPORT group underwent biphasic protocol target saturations of 85% to 92% at younger than 34 weeks' CGA and greater than 95% at 34 weeks' CGA or older. The post-SUPPORT group underwent a constant 91% to 95% target. Main Outcomes and Measures: Primary outcome was incidence of type 1 ROP. Secondary outcomes were incidence of any ROP, time to full vascularization, and mortality. Results: Of 596 eligible infants, 562 were included in ophthalmic analysis. Three hundred three patients were boys (54%); 399 were white (71%), 87 were black (15%), and 76 were of other or unknown race/ethnicity (14%). Mean (SD) CGA and birth weight were 29 (2) weeks and 1151 (346) g, respectively. Any ROP overall increased (53 [20%] pre-SUPPORT vs n = 86 [28%] post-SUPPORT; absolute difference, 8%; 95% CI, 1%-15%; odds ratio, 1.6; 95% CI, 1.05-2.3; P = .03). Type 1 ROP increased in the post-SUPPORT era (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; odds ratio, 2.7; 95% CI, 1.05-6.9; P = .03). There was a delay in vascularization in the post-SUPPORT group (n = 6 [2%] pre-SUPPORT vs n = 18 [6%] post-SUPPORT; absolute difference, 4%; 95% CI, 0.4%-7%; P = .03). Conclusions and Relevance: Compared with static oxygen standards, biphasic oxygen targets are associated with decreased incidence and severity of ROP without increasing mortality.
Authors: Ana Maria Solans Pérez de Larraya; José María Ortega Molina; José Uberos Fernández; Amanda Rocío González Ramírez; José Luis García Serrano Journal: Biomed Res Int Date: 2019-04-24 Impact factor: 3.411