Department of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
Newborn Care Group at Pennsylvania Hospital, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania.
JAMA Ophthalmol. 2019 Feb 1;137(2):160-166. doi: 10.1001/jamaophthalmol.2018.5520.
Most premature infants will not develop retinopathy of prematurity (ROP) of clinical relevance, yet screening evaluations often continue beyond hospital discharge, even for those infants without ROP.
To identify the characteristics of infants at low risk for ROP, for whom further postdischarge screening may be of limited value.
DESIGN, SETTING, AND PARTICIPANTS: This study took place in North American neonatal intensive care units where clinicians had expertise in ROP. Infants with birth weight less than 1251 g who were born at or transferred into an Telemedicine Approaches to Evaluating Acute-Phase ROP (e-ROP) study center were enrolled. The study included post hoc analysis of prospectively collected in-hospital ROP examination results among infants enrolled in the e-ROP study. We characterized infants without ROP and performed logistic regression on the subset of infants who were 27 to 33 weeks' gestational age to determine characteristics associated with the absence of ROP during all in-hospital examinations.
The main measure was the absence of ROP prior to hospital discharge; the main outcome was treatment for ROP.
A total of 1257 infants born at 22 to 35 weeks' gestation (median [interquartile range (IQR)], 26 [25-28] weeks) with birth weights less than 1251 g (median [IQR], 860 [690-1040] g) underwent 4113 ROP examinations between 31 and 47 weeks' postmenstrual age. Overall, 1153 examinations (38%) showed no ROP, and 456 infants (36%) did not have ROP prior to study center discharge or study end point. Among infants without ROP during examinations at 32 and 33 weeks' postmenstrual age, 16 (9.4%) and 14 (5.3%) subsequently underwent ROP treatment, respectively. At hospital discharge, there was no ROP in 59% of infants of 27 to 33 weeks' gestational age, compared with 15% of those who were less than 27 weeks' gestational age (difference, 44% [95% CI, 38.5%-48.1%]; P ≤ .001). With more than 85% follow-up among infants without ROP by 37 weeks' postmenstrual age, none (95% CI, 0%-0.98%) were treated for ROP. In multivariate analysis of infants born at 27 to 33 weeks' gestation, larger birth weight (OR, 4.1 [95% CI, 1.6-10.3]) and higher gestational age (OR, 4.0 [95% CI, 1.5-10.8]) were significantly associated with absence of ROP.
These findings suggest that, for infants of 27 weeks' gestational age or greater and birth weights larger than 750 g, if no ROP has been detected by discharge at near-term postmenstrual age, then further ROP surveillance has limited value. Studies of all infants at risk are needed to develop more specific, objective criteria for termination of ROP surveillance and focus resources on infants at higher risk of ROP.
ClinicalTrials.gov Identifier: NCT01264276.
大多数早产儿不会出现临床相关的早产儿视网膜病变(ROP),但即使对于没有 ROP 的婴儿,筛查评估通常也会在出院后继续进行。
确定 ROP 风险较低的婴儿的特征,对于这些婴儿,进一步的出院后筛查可能价值有限。
设计、地点和参与者:本研究在美国和加拿大的新生儿重症监护病房进行,那里的临床医生具有 ROP 专业知识。出生体重小于 1251 克且出生或转入远程医疗评估急性 ROP(e-ROP)研究中心的婴儿被纳入研究。本研究对 e-ROP 研究中前瞻性收集的住院期间 ROP 检查结果进行了事后分析。我们对没有 ROP 的婴儿进行了特征描述,并对 27 至 33 周胎龄的婴儿进行了逻辑回归,以确定与所有住院期间检查中没有 ROP 相关的特征。
主要指标是在出院前没有 ROP;主要结果是 ROP 的治疗。
共有 1257 名胎龄 22 至 35 周(中位数[四分位间距(IQR)],26 [25-28] 周)、出生体重小于 1251 克(中位数[IQR],860 [690-1040] 克)的婴儿在 31 至 47 周的胎龄时接受了 4113 次 ROP 检查。总体而言,1153 次检查(38%)未发现 ROP,456 名婴儿(36%)在研究中心出院或研究终点前没有 ROP。在 32 和 33 周胎龄的检查中没有 ROP 的婴儿中,分别有 16 名(9.4%)和 14 名(5.3%)随后接受了 ROP 治疗。在出院时,27 至 33 周胎龄的婴儿中 59%没有 ROP,而胎龄小于 27 周的婴儿中 15%没有 ROP(差异,44%[95%CI,38.5%-48.1%];P≤0.001)。在没有 ROP 的婴儿中,有超过 85%在 37 周的胎龄时接受了随访,没有一个婴儿(95%CI,0%-0.98%)接受了 ROP 治疗。在对 27 至 33 周胎龄出生的婴儿进行的多变量分析中,较大的出生体重(比值比[OR],4.1[95%CI,1.6-10.3])和较高的胎龄(OR,4.0[95%CI,1.5-10.8])与没有 ROP 显著相关。
这些发现表明,对于胎龄 27 周及以上且出生体重大于 750 克的婴儿,如果在接近足月的胎龄时没有发现 ROP,则进一步的 ROP 监测价值有限。需要对所有有风险的婴儿进行研究,以制定更具体、更客观的终止 ROP 监测标准,并将资源集中在 ROP 风险较高的婴儿身上。
ClinicalTrials.gov 标识符:NCT01264276。