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Does the incidence and severity of retinopathy of prematurity (ROP) decrease with biphasic oxygen targets compared with static standards of the Surfactant, Positive Pressure, and Pulse Oximetry Trial (SUPPORT) without affecting mortality?
In a cohort study comparing incidence of type 1 ROP using a biphasic oxygen standard with static SUPPORT standards, type 1 ROP increased in the postintervention cohort (2% pre-SUPPORT vs 6% post-SUPPORT). There was an increase in any ROP overall (20% pre-SUPPORT vs 28% post-SUPPORT), and mortality was unchanged (5% pre-SUPPORT and 6% post-SUPPORT).
Biphasic oxygen targets are associated with decreased incidence and severity of ROP without increasing mortality.
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.
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.
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.
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.
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Corresponding Author: Jonathan E. Sears, MD, Cole Eye Institute and Cellular and Molecular Medicine, 9500 Euclid Ave, Cleveland, OH 44195 (email@example.com).
Accepted for Publication: December 5, 2018.
Published Online: February 14, 2019. doi:10.1001/jamaophthalmol.2018.7021
Author Contributions: Drs Shukla and Sears had full access to all the data in the study and takes responsibility for the integrity of the data and the accuracy of the data analysis.
Concept and design: Shukla, Moore, Rodriguez, Hoppe.
Study concept and design: Sears.
Acquisition, analysis, or interpretation of data: Shukla, Sonnie, Worley, Sharma, Howard, Sears.
Drafting of the manuscript: Shukla, Sonnie, Worley, Howard, Moore, Rodriguez, Sears.
Critical revision of the manuscript for important intellectual content: Shukla, Worley, Sharma, Moore, Rodriguez, Hoppe, Sears.
Statistical analysis: Worley, Sharma, Sears.
Administrative, technical, or material support: Shukla, Sonnie, Sharma, Howard, Moore, Rodriguez, Hoppe, Sears.
Study supervision: Sears.
Conflict of Interest Disclosures: None reported.
Funding/Support: Grant support was recived from the National Institutes of Health (R01 EY024972; Dr Sears); The Hartwell Foundation Biomedical Research Fellowship (Dr Sears); and the Research to Prevent Blindness Physician Scientist award (Dr Sears).
Role of the Funder/Sponsor: The funding sources had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, or approval of the manuscript; and decision to submit the manuscript for publication.
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