Postnatal Growth and Retinopathy of Prematurity Study: Rationale, Design, and Subject Characteristics

ABSTRACT

Purpose: Postnatal-growth-based predictive models demonstrate strong potential for improving the low specificity of retinopathy of prematurity (ROP) screening. Prior studies are limited by inadequate sample size. We sought to study a sufficiently large cohort of at-risk infants to enable development of a model with highly precise estimates of sensitivity for severe ROP.

Methods: The Postnatal Growth and ROP (G-ROP) Study was a multicenter retrospective cohort study of infants at 30 North American hospitals during 2006–2012. A total of 65 G-ROP-certified abstractors submitted data to a secure, web-based database. Data included ROP examination findings, treatments, complications, daily weight measurements, daily oxygen supplementation, maternal/infant demographics, medical comorbidities, surgical events, and weekly nutrition. Data quality was monitored with system validation rules, data audits, and discrepancy algorithms.

Results: Of 11,261 screened infants, 8334 were enrolled, and 2927 had insufficient data due to transfer, discharge, or death. Of the enrolled infants, 90% (7483) had a known ROP outcome and were included in the study. Median birth weight was 1070 g (range 310–3000g) and mean gestational age 28 weeks (range 22–35 weeks). Severe ROP (Early Treatment of Retinopathy type 1 or 2) developed in 931 infants (12.5%).

Conclusion: Successful incorporation of a predictive model into ROP screening requires confidence that it will capture cases of severe ROP. This dataset provides power to estimate sensitivity with half-confidence interval width of less than 0.5%, determined by the high number of severe ROP cases. The G-ROP Study represents a large, diverse cohort of at-risk infants undergoing ROP screening. It will facilitate evaluation of growth-based algorithms to improve efficiency of ROP screening.

KEYWORDS:

• Predictive model
• prematurity
• retinopathy of prematurity
• screening

Acknowledgments

Presented in part at the 2016 Annual Meeting of the American Association for Pediatric Ophthalmology and Strabismus in Vancouver, British Columbia, Canada.

Declaration of interest

The authors report no conflicts of interest. The authors alone are responsible for the writing and content of this article.

Funding

Supported by National Institutes of Health grant 1R01EY021137-01A1. The sponsor or funding organization had no role in the design or conduct of this research.

Additional information

Funding

Supported by National Institutes of Health grant 1R01EY021137-01A1. The sponsor or funding organization had no role in the design or conduct of this research.