Safety of Retinopathy of Prematurity Examination and Imaging in Premature Infants

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• 作者：Kelly C. Wade ; MD ; PhD ; MSCE¹ ; ^{Kelly.wade@uphs.upenn.edu" class="auth_mail" title="E-mail the corresponding author} ; Maxwell Pistilli ; MS² ; Agnieshka Baumritter ; MS³ ; Karen Karp ; BSN³ ; Alice Gong ; MD⁴ ; Alex R. Kemper ; MD ; MPH ; MS⁵ ; Gui-Shuang Ying ; PhD² ; Graham Quinn ; MD ; MSCE² ; ³ ; on behalf of the e-Retinopathy of Prematurity Study Cooperative Group^&lowast ; Graham E. Quinn ; MD (PI) ; MSCE ; Kelly Wade ; MD ; PhD ; Agnieshka Baumritter ; MS ; Trang B. Duros ; Lisa Erbring ; Michael X. Repka ; MD (PI) ; Jennifer A. Shepard ; CRNP ; David Emmert ; BA ; C. Mark Herring ; Deborah VanderVeen ; MD (PI) ; Suzanne Johnston ; MD ; Carolyn Wu ; MD ; Jason Mantagos ; MD ; Danielle Ledoux ; MD ; Tamar Winter ; RN ; BSN ; IBCLC ; Frank Weng ; Theresa Mansfield ; RN ; Don L. Bremer ; MD (PI) ; Mary Lou McGregor ; MD ; Catherine Olson Jordan ; MD ; David L. Rogers ; MD ; Rae R. Fellows ; MEd ; CCRC ; Suzanne Brandt ; RNC ; BSN ; Brenda Mann ; RNC ; BSN ; David Wallace ; MD (PI) ; Sharon Freedman ; MD ; Sarah K. Jones ; Du Tran-Viet ; Rhonda &ldquo ; Michelle&rdquo ; Young ; Charles C. Barr ; MD (PI) ; Rahul Bhola ; MD ; Craig Douglas ; MD ; Peggy Fishman ; MD ; Michelle Bottorff ; Brandi Hubbuch ; RN ; MSN ; NNP-BC ; Rachel Keith ; PhD ; Erick D. Bothun ; MD (PI) ; Inge DeBecker ; MD ; Jill Anderson ; MD ; Ann Marie Holleschau ; BA ; CCRP ; Nichole E. Miller ; MA ; RN ; NNP ; Darla N. Nyquist ; MA ; RN ; NNP ; R. Michael Siatkowski ; MD (PI) ; Lucas Trigler ; MD ; Marilyn Escobedo ; MD ; Karen Corff ; MS ; ARNP ; NNP-BC ; Michelle Huynh ; MS ; ARNP ; Kelli Satnes ; MS ; ARNP ; NNP-BC ; Monte D. Mills ; MD (PI) ; Will Anninger ; MD ; Gil Binenbaum ; MD ; MSCE ; Graham Quinn ; MD ; MSCE ; Karen A. Karp ; BSN ; Denise Pearson ; COMT ; Alice Gong ; MD (PI) ; John Stokes ; MD ; Clio Armitage Harper ; MD ; Laurie Weaver ; Carmen McHenry ; BSN ; Kathryn Conner ; Rosalind Heemer ; Elnora Cokley ; RNC ; Robert Hoffman ; MD (PI) ; David Dries ; MD ; Katie Jo Farnsworth ; Deborah Harrison ; MS ; Bonnie Carlstrom ; Cyrie Ann Fry ; CRA ; OCT-C ; David Morrison ; MD ; Sean Donahue ; MD ; Nancy Benegas ; MD ; Sandy Owings ; COA ; CCRP ; Sandra Phillips ; COT ; CRI ; Scott Ruark ; Anna Ells ; MD ; FRCS (PI) ; Patrick Mitchell ; MD ; April Ingram ; Rosie Sorbie ; RN ; Gui-shuang Ying ; PhD (PI) ; Maureen Maguire ; PhD ; Mary Brightwell-Arnold ; BA ; SCP ; Max Pistilli ; MS ; Kathleen McWilliams ; CCRP ; Sandra Harkins ; Ebenezer Daniel ; MBBS ; MS ; MPH (PI) ; E. Revell Martin ; BA ; Candace R. Parker Ostroff ; Krista Sepielli ; Eli Smith ; Claressa Whearry ; Antonio Capone ; MD ; G. Baker Hubbard ; MD ; Anna Ells ; MD ; FRCS ; Peter Lloyd Hildebrand ; MD (PI) ; Kerry Davis ; G. Carl Gibson ; Regina Hansen ; Alex R. Kemper ; MD ; MPH ; MS (PI) ; Lisa Prosser ; PhD ; David C. Musch ; PhD ; MPH (Chair) ; Stephen P. Christiansen ; MD ; Ditte J. Hess ; CRA ; Steven M. Kymes ; PhD ; SriniVas R. Sadda ; MD ; Ryan Spaulding ; PhD
• 关键词：AE ; Adverse event ; BIO ; Binocular indirect ophthalmoscopy ; BW ; Birth weight ; CPAP ; Continuous positive airway pressure ; e-ROP ; Telemedicine Approaches to Evaluating Acute Phase-ROP ; GA ; Gestational age ; NICU ; Neonatal intensive care unit ; PMA ; Postmenstrual age ; ROP ; Retinopathy of prematurity ; SAE ; Serious adverse event
• 刊名：The Journal of Pediatrics
• 出版年：2015
• 出版时间：November 2015
• 年：2015
• 卷：167
• 期：5
• 页码：994-1000.e2
• 全文大小：175 K

文摘

To describe adverse events (AEs) and noteworthy clinical or ocular findings associated with retinopathy of prematurity (ROP) evaluation procedures.

Study design

Descriptive analysis of predefined AEs and noteworthy findings reported in a prospective observational cohort study of infants <1251 g birth weight who had ROP study visits consisting of both binocular indirect ophthalmoscopy (BIO) and digital retinal imaging. We compared infant characteristics during ROP visits with and without AEs. We compared respiratory support, nutrition, and number of apnea, bradycardia, or hypoxia events 12 hours before and after ROP visits.

Results

A total of 1257 infants, mean birth weight 802 g, had 4263 BIO and 4048 imaging sessions (total 8311 procedures). No serious AEs were related to ROP visits. Sixty-five AEs were reported among 61 infants for an AE rate of 4.9% infants (61/1257) or 0.8% total procedures (65/8311 BIO + imaging). Most AEs were due to apnea, bradycardia, and/or hypoxia (68%), tachycardia (16%), or emesis (8%). At ROP visit, infants with AEs, compared with those without, were more likely to be on mechanical ventilation (26% vs 12%, P = .04) even after adjustment for weight and postmenstrual age. Noteworthy clinical findings were reported during 8% BIO and 15% imaging examinations. Respiratory and nutrition support were not significantly different before and after ROP evaluations.

Conclusions

Retinal imaging by nonphysicians combined with BIO was safe. Noteworthy clinical findings occurred during both procedures. Ventilator support was a risk factor for AEs. Monitoring rates of AEs and noteworthy findings are important to the safe implementation of ROP imaging protocols.

Trial registration

Clinicaltrials.gov: NCT01264276.