Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment

Girija Natarajan; Seetha Shankaran; Tracy L. Nolen; Amaanti Sridhar; Kathleen A. Kennedy; Susan R. Hintz; Dale L. Phelps; Sara B. DeMauro; Waldemar A. Carlo; Marie G. Gantz; Abhik Das; Rachel G. Greenberg; Noelle E. Younge; Joseph M. Bliss; Ruth Seabrook; Pablo J. Sánchez; Myra H. Wyckoff; Edward F. Bell; Betty R. Vohr; Rosemary D. Higgins

doi:10.1542/peds.2018-3537

Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment

Girija Natarajan, Seetha Shankaran, Tracy L. Nolen, Amaanti Sridhar, Kathleen A. Kennedy, Susan R. Hintz, Dale L. Phelps, Sara B. DeMauro, Waldemar A. Carlo, Marie G. Gantz, Abhik Das, Rachel G. Greenberg, Noelle E. Younge, Joseph M. Bliss, Ruth Seabrook, Pablo J. Sánchez, Myra H. Wyckoff, Edward F. Bell, Betty R. Vohr, Rosemary D. Higgins

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Abstract

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 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver 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 (N = 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; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .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]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .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.

Original language	English (US)
Article number	e20183537
Journal	Pediatrics
Volume	144
Issue number	2
DOIs	https://doi.org/10.1542/peds.2018-3537
State	Published - 2019

ASJC Scopus subject areas

Pediatrics, Perinatology, and Child Health

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Natarajan, G., Shankaran, S., Nolen, T. L., Sridhar, A., Kennedy, K. A., Hintz, S. R., Phelps, D. L., DeMauro, S. B., Carlo, W. A., Gantz, M. G., Das, A., Greenberg, R. G., Younge, N. E., Bliss, J. M., Seabrook, R., Sánchez, P. J., Wyckoff, M. H., Bell, E. F., Vohr, B. R., & Higgins, R. D. (2019). Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment. Pediatrics, 144(2), Article e20183537. https://doi.org/10.1542/peds.2018-3537

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 2019, 'Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment', Pediatrics, vol. 144, no. 2, e20183537. https://doi.org/10.1542/peds.2018-3537

@article{2eb63bd594ac49179261d1a967db7ba8,

title = "Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment",

abstract = "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 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver 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 (N = 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; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .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]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .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.",

author = "Girija Natarajan and Seetha Shankaran and Nolen, {Tracy L.} and Amaanti Sridhar and Kennedy, {Kathleen A.} and Hintz, {Susan R.} and Phelps, {Dale L.} and DeMauro, {Sara B.} and Carlo, {Waldemar A.} and Gantz, {Marie G.} and Abhik Das and Greenberg, {Rachel G.} and Younge, {Noelle E.} and Bliss, {Joseph M.} and Ruth Seabrook and S{\'a}nchez, {Pablo J.} and Wyckoff, {Myra H.} and Bell, {Edward F.} and Vohr, {Betty R.} and Higgins, {Rosemary D.}",

note = "Publisher Copyright: Copyright {\textcopyright} 2019 by the American Academy of Pediatrics",

year = "2019",

doi = "10.1542/peds.2018-3537",

language = "English (US)",

volume = "144",

journal = "Pediatrics",

issn = "0031-4005",

publisher = "American Academy of Pediatrics",

number = "2",

}

TY - JOUR

T1 - Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment

AU - Natarajan, Girija

AU - Shankaran, Seetha

AU - Nolen, Tracy L.

AU - Sridhar, Amaanti

AU - Kennedy, Kathleen A.

AU - Hintz, Susan R.

AU - Phelps, Dale L.

AU - DeMauro, Sara B.

AU - Carlo, Waldemar A.

AU - Gantz, Marie G.

AU - Das, Abhik

AU - Greenberg, Rachel G.

AU - Younge, Noelle E.

AU - Bliss, Joseph M.

AU - Seabrook, Ruth

AU - Sánchez, Pablo J.

AU - Wyckoff, Myra H.

AU - Bell, Edward F.

AU - Vohr, Betty R.

AU - Higgins, Rosemary D.

PY - 2019

Y1 - 2019

N2 - 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 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver 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 (N = 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; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .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]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .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.

AB - 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 1 6/7 weeks' gestational age) infants admitted to the Eunice Kennedy Shriver 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 (N = 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; P = .02) and longer durations of conventional ventilation (35 [21-58] vs 33 [18-49] days; P = .04) and supplemental oxygen (112 [94-120] vs 105 [84.5-120] days; P = .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]; P = .002), a cognitive score,85 (aOR 1.78 [95% CI 1.09 to 2.91]; P = .02), and a Gross Motor Functional Classification Scale level $2 (aOR 1.73 [95% CI 1.04 to 2.88]; P = .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.

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Neurodevelopmental outcomes of preterm infants with retinopathy of prematurity by treatment

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