|Title||Neurodevelopmental Outcomes of Preterm Infants With Retinopathy of Prematurity by Treatment.|
|Publication Type||Journal Article|
|Year of Publication||2019|
|Authors||Natarajan G, Shankaran S, Nolen TL, Sridhar A, Kennedy KA, Hintz SR, Phelps DL, DeMauro SB, Carlo WA, Gantz MG, Das A, Greenberg RG, Younge NE, Bliss JM, Seabrook R, Sánchez PJ, Wyckoff MH, Bell EF, Vohr BR, Higgins RD|
|Date Published||2019 08|
|Keywords||Adult, Angiogenesis Inhibitors, Bevacizumab, Child Development, Cohort Studies, Female, Humans, Infant, Newborn, Infant, Premature, Male, Neurodevelopmental Disorders, Prospective Studies, Retinopathy of Prematurity, Retrospective Studies|
OBJECTIVE: Among extremely preterm infants, we evaluated whether bevacizumab therapy compared with surgery for retinopathy of prematurity (ROP) is associated with adverse outcomes in early childhood.
METHODS: This study was a retrospective analysis of prospectively collected data on preterm (22-26 + 6/7 weeks' gestational age) infants admitted to the National Institute of Child Health and Human Development Neonatal Research Network centers who received bevacizumab or surgery exclusively for ROP. The primary outcome was death or severe neurodevelopmental impairment (NDI) at 18 to 26 months' corrected age (Bayley Scales of Infant and Toddler Development, Third Edition cognitive or motor composite score <70, Gross Motor Functional Classification Scale level ≥2, bilateral blindness or hearing impairment).
RESULTS: The cohort ( = 405; 214 [53%] boys; median [interquartile range] gestational age: 24.6 [23.9-25.3] weeks) included 181 (45%) infants who received bevacizumab and 224 (55%) who underwent ROP surgery. Infants treated with bevacizumab had a lower median (interquartile range) birth weight (640 [541-709] vs 660 [572.5-750] g; = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; = .01). Death or severe NDI (adjusted odds ratio [aOR] 1.42; 95% confidence interval [CI] 0.94 to 2.14) and severe NDI (aOR 1.14; 95% CI 0.76 to 1.70) did not differ between groups. Odds of death (aOR 2.54 [95% CI 1.42 to 4.55]; = .002), a cognitive score <85 (aOR 1.78 [95% CI 1.09 to 2.91]; = .02), and a Gross Motor Functional Classification Scale level ≥2 (aOR 1.73 [95% CI 1.04 to 2.88]; = .04) were significantly higher with bevacizumab therapy.
CONCLUSIONS: In this multicenter cohort of preterm infants, ROP treatment modality was not associated with differences in death or NDI, but the bevacizumab group had higher mortality and poor cognitive outcomes in early childhood. These data reveal the need for a rigorous appraisal of ROP therapy.
|PubMed Central ID||PMC6855825|
|Grant List||K23 DK120960 / DK / NIDDK NIH HHS / United States |
UG1 HD027853 / HD / NICHD NIH HHS / United States
U10 HD040689 / HD / NICHD NIH HHS / United States
UG1 HD027904 / HD / NICHD NIH HHS / United States
UG1 HD027880 / HD / NICHD NIH HHS / United States
UG1 HD087229 / HD / NICHD NIH HHS / United States
UG1 HD040689 / HD / NICHD NIH HHS / United States