Supplemental therapeutic oxygen for prethreshold retinopathy of prematurity (STOP-ROP), a randomized, controlled trial. I: Primary outcomes

Authors
Phelps, DL Lindblad, A Bradford, JD Wood, NE Oden, NL Cole, C MacKinnon, B Yaffe, A Everett, DF Wright, L Krulewitch, C Brozanski, BS Young, T Scott, M Hawkins, BS Begg, CB Bell, EF Buckley, EG Hay, WW Kushner, BJ Snouck-Hurgronje, L Taylor, CR Oden, NL Lindblad, AS Bachy, C Berlin, SH Brandt, D Guzzey, M Henson, L Jolles, B Stine, E Thomas-Sharp, C Van Lare, J Yaffe, A Cole, C Stewart, J MacKinnon, B Alexander, T Anderson, C Ashrafzadeh, M Baumal, C Bhatt, A Blocker, R Brown, E Cordova, M Dacey, MP Duker, J Eagle, J Eichenwald, E Faherty, C Fujii, A Gray, J Hartnett, ME Harvey-Wilkes, K Hetrick, J Hughes, M Ip, M Izatt, S Lacy, R Levy, J Margolis, T McAlmon, KR McCabe, O Moore, M Niffenegger, J Nikou, S Petersen, R Petit, K Pierce, EA Powers, B Pursley, M Reichel, E Remis, L Rivellese, M Shephard, BA Sorkin, J Stark, A Struzik, S Tran, T VanderVeen, DK Vreeland, P Wilker, R Wright, J Kim, V Desai, V Rutledge, B McClead, RE Fellows, R Biel, M Bremer, DL Maddox, R Mann, B McGregor, ML Nye, C Peterman, P Rogers, GL Rosenberg, EM Seguin, J Stephen, S Anderson, CW Cordero, L Spitzer, AR Corcoran, L Cullen, J Fosnot, J Desai, S Fricko, J Giannetta, J Harris, MC Hepps, D Hertle, R Holt, B Leef, K McNamara, JA Miller, D Mooney, K Naidoff, M Pleasure, JR Porat, R Quinn, G Saunders, T Schaffer, D Spear, M Spinner, S Tasman, W Vander, JF Wilson, M Zirin, S Bradford, JD Ables, P Bonner, C Brodsky, M Davis, E Frost, K Hall, RW Harper, R Thomas, BR Barr, CC Adamkin, D Douglas, CH Fishman, PH Hamlyn-Forti, N Hilbert, T Roberts, J Whittington, G Wright, J Oh, W Adams, N Andrews, D Geltzer, AI Hensman, A Philo-Heroux, S Rothstein, RW Snady-McCoy, L Stoll, B Capone, A Critz, AD Drack, AV Goulding, CH Martin, DF Olsen, TW Sternberg, P White, MB Lemons, JA Appel, DD Denne, SC Ellis, F Helveston, E McKee, A Neely, D Plager, D Sprunger, D Wilson, D Wright, LD Stevenson, DK Alcorn, DM Ball, MB Bone, D Fleisher, BE Gaynon, MW Good, WV Inguillo, D Burke, M Carden, S Colegate, S Good, WV Grisby, C Hitchcock, B Hutchins, RK Khan, AO Kotagal, U Mersmann, M Munson, K Sheppard, RW West, C Korones, S Bada, H Borirak, S Brewer, B Camp, G Dempsey, S Devine, C Downie, A Faber, DW Grimes, S Hairston, R Hensley, B Hudson, T Johnson, V Katz, A Manejwala, L Schwartz, J Zocchi, K Landers, M Jewart, B Tyson, JE Kennedy, K Anand, R Hensley, G Metrikin, D Spencer, R Warner, S Weakley, D Wilson, CA Burchfield, J Bedard, M Baker, JD Bara, R Casabar, R Liang, KC Lucas, W Muran, G O'Malley, E Pulkin, JE Roarty, J Shankaran, S Trese, M Ehrenkranz, RA Bartley, C Gettner, PA Juliano, G Konstantino, M Moylan, S Peterec, SM Sears, J Sherwonit, E Stoessel, K Easa, D Drouilhet, JH Ash, K Atebara, N Balaraman, V Debuque, L Douglas, J Fritz, E Hirai, C Iwamoto, L Kau, S Kokame, G Liao, P Loo, S Meister, J Murai, D Nakamura, KT Patrinos, ME Pelke, S Post, G Sood, S Sroat, DA Tinsley, L Wong, B Wong, V Brozanski, BS Cheng, KP Bergren, RL Biglan, AW Davis, JS Doft, B Hoffman, ME Jones, J Laneri, G Lobes, LA Olsen, KR Rinkoff, J Vazquez, RL Phelps, DL Wood, N Brown, K Mansfield, LR Markowitz, GD Guillet, E Morris, J Nicoletta, K Rose, S Sinkin, R Tingley, D Vanderlinde, R Shutts, S Carrion, V Cummings, J Awner, S Marano, D Olitsky, S Reynolds, J Terpin, M Gordon, R Diamond, JG Hasty-Voelkel, B Neff, D Reynolds, J Storch, TG Weber, PA Barondes, MJ Browne, L Combs, A Elbaba, F Gallagher, K Gerontis, CC King, K Kleinman, L Kodsi, S LaGamma, E Lipsitz, P Marmor, M McGovern, RV Wilkens, B Kokomoor, FW Burton, JE Enlow, MK Feick, HJ Jaberg, CE Kelley, A Kisak, MJ Locastro, AJ Peter, CA Tsai, TJ Shapiro, MJ Holmes, JM Abbasi, I Adeni, S Aldana, O Alter, D Annerino, KA Arora, S Becker, H Bhat, R Bigger, HR Bunjapamai, W Cattamanchi, G Cohen, JA Collins, JW Cronin, CM Daily, MJ Davis, CL De Alba, F DeKowski, SA Deddish, RB Dorton, A Dray, PB Duffner, LA Dusek, L Dyer, DS Enger, MC Fisher, JB Fiumara, A Friedlander, S Ghai, V Gieser, JP Gieser, RG Greenwald, MJ Gunawardene, NR Gupta, B Guyer, N Hennessy, AM Hernandez, G Hyde, DC Illian, M Jain, R Jansen, RD Kaufman, LM Kling, P Kurtz, RM Lai, C Leamy, MJ Lukose, A Lyon, AT MacCumber, M McCulloch, KTM McDonnell, JF Menner, C Mets, MB Millard, DD Miller, MT Mockovak, ME Morose, A Naber, M Nitz, P Ogata, ES Palanpurwala, KA Paulin, CA Payton, J Phillpotts, BA Pyati, S Raju, TNK Resnick, KI Rupar, B Sajous, C Santiago, NE Dunseath-Shuman, B Simmons, RA Singh, A Skopec, DL Solomon, MJ Squires, MA Ticho, BH Vasan, U Vidyasagar, D Wall, SN Weinberg, AB Weinberg, DV Wilks, A Zikos, E Banagale, RC Aaby, AA Banta-Wright, SA Baxter, LM Bellant, JK Benda, G Binder, ND Brown, WJ Cheldelin, L Christensen, L DeVito, V Dolphin, NG Dunham, S Edwards, A Gilhooly, JT Goodman, S Huston, R Lewallen, PK McDonald, J Mischel, R Murphy, DL Newman, V Novack, CM Owen, S Palmer, EA Pillers, DM Powers, M Rimmer, S Robertson, J Smith, SA Tongue, AC Wallen, LD Wheeler, DT Stern, ME Auerbach, R Dorfman, M Poliak, JG Weinstein, B Wigton, K Preslan, MW Gewolb, IH Aristimuno, B Birenbaum, HJ Bristol, B Dulkerian, S Gutberlet, RL Hutcheson, K Palmer, TW Repka, MX Schoedel, C Steidl, S Tanbusch, T Waeltermann, J Wong, RV Feman, SS Cotton, RB Donahue, S Johnson, DA Law, AB Sinatra, RB Steele, SD Walsh, WF Kirk, J Stewart, MW Bolling, JP Bryan, JS Chapman-Shaw, VL Garrison, RD Hered, RW Higgison, J Hunter, LR Lambrou, FH Ott, LA Pogrebniak, AE Self, M Vargo, V Vaughn, AJ Young, J Young, TL Angel, CS Bendel, CM Brasel, D Chisholm, K Christiansen, S Cifuentes, RF Cook, SM Egbert, JE Engel, RR Fangman, J Geier, P Holleschau, AM Janda, AM Maxwell, M Miller, C Mills, MM Neely, KA Pier, T Rebertus, KS Rodman, WP Summers, CG Trower, NL McCaffree, MA Scott, M Bradford, RH Brown, RD Butcher, J Co, E Corff, K Grellner, A Henson, L King, L Lopez, S Shofner, JM Tolentino, TA Wlodaver, AG Satish, M Bradley, B Dabbs, CK Gall, VM Gunther, K Rosenthal, JG Troxell, B Droste, PJ Alexander, C Beaumont, E Glazer, L Johnson, L Margherio, AR
Citation
Dl. Phelps et al., Supplemental therapeutic oxygen for prethreshold retinopathy of prematurity (STOP-ROP), a randomized, controlled trial. I: Primary outcomes, PEDIATRICS, 105(2), 2000, pp. 295-310
Citations number
40
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Pediatrics,"Medical Research General Topics
Journal title
PEDIATRICS
ISSN journal
0031-4005 → ACNP
Volume
105
Issue
2
Year of publication
2000
Pages
295 - 310
Database
ISI
SICI code
0031-4005(200002)105:2<295:STOFPR>2.0.ZU;2-V
Abstract
Objective. To determine the efficacy and safety of supplemental therapeutic oxygen for infants with prethreshold retinopathy of prematurity (ROP) to r educe the probability of progression to threshold ROP and the need for peri pheral retinal ablation. Methods. Premature infants with confirmed prethreshold ROP in at least 1 ey e and median pulse oximetry <94% saturation were randomized to a convention al oxygen arm with pulse oximetry targeted at 89% to 94% saturation or a su pplemental arm with pulse oximetry targeted at 96% to 99% saturation, for a t least 2 weeks, and until both eyes were at study endpoints. Certified exa miners masked to treatment assignment conducted weekly eye examinations unt il each study eye reached ophthalmic endpoint. An adverse ophthalmic endpoi nt for an infant was defined as reaching threshold criteria for laser or cr yotherapy in at least 1 study eye. A favorable ophthalmic endpoint was regr ession of the ROP into zone III for at least 2 consecutive weekly examinati ons or full retinal vascularization. At 3 months after the due date of the infant, ophthalmic findings, pulmonary status, growth, and interim illnesse s were again recorded. Results. Six hundred forty-nine infants (325 conventional and 324 supplemen tal) were enrolled from 30 centers over 5 years. Five hundred ninety-seven (92.0%) infants attained known ophthalmic endpoints, and 600 (92%) complete d the ophthalmic 3-month assessment. The rate of progression to threshold i n at least 1 eye was 48% in the conventional arm and 41% in the supplementa l arm. After adjustment for baseline ROP severity stratum, plus disease, ra ce, and gestational age, the odds ratio (supplemental vs conventional) for progression was .72 (95% confidence interval: .52, 1.01). Final structural status of all study eyes at 3 months of corrected age showed similar rates of severe sequelae in both treatment arms: retinal detachments or folds (4. 4% conventional vs 4.1% supplemental), and macular ectopia (3.9% convention al vs 3.9% supplemental). Within the prespecified ROP severity strata, ROP progression rates were lower with supplemental oxygen than with conventiona l oxygen, but the differences were not statistically significant. A post ho c subgroup analysis of plus disease (dilated and tortuous vessels in at lea st 2 quadrants of the posterior pole) suggested that infants without plus d isease may be more responsive to supplemental therapy (46% progression in t he conventional arm vs 32% in the supplemental arm) than infants with plus disease (52% progression in conventional vs 57% in supplemental). Pneumonia and/or exacerbations of chronic lung disease occurred in more inf ants in the supplemental arm (8.5% conventional vs 13.2% supplemental). Als o, at 50 weeks of postmenstrual age, fewer conventional than supplemental i nfants remained hospitalized (6.8% vs 12.7%), on oxygen (37.0% vs 46.8%), a nd on diuretics (24.4% vs 35.8%). Growth and developmental milestones did n ot differ between the 2 arms. Conclusions. Use of supplemental oxygen at pulse oximetry saturations of 96 % to 99% did not cause additional progression of prethreshold ROP but also did not significantly reduce the number of infants requiring peripheral abl ative surgery. A subgroup analysis suggested a benefit of supplemental oxyg en among infants who have prethreshold ROP without plus disease, but this f inding requires additional study. Supplemental oxygen increased the risk of adverse pulmonary events including pneumonia and/or exacerbations of chron ic lung disease and the need for oxygen, diuretics, and hospitalization at 3 months of corrected age. Although the relative risk/benefit of supplement al oxygen for each infant must be individually considered, clinicians need no longer be concerned that supplemental oxygen, as used in this study, wil l exacerbate active prethreshold ROP.