Department of Pediatrics, University of Washington, Seattle, WA.
Department of Biostatistics, University of Washington, Seattle, WA.
J Pediatr. 2021 Nov;238:102-109.e8. doi: 10.1016/j.jpeds.2021.07.019. Epub 2021 Jul 27.
To test whether an increased iron dose is associated with improved neurodevelopment as assessed by the Bayley Scales of Infant Development, third edition (BSID-III) among infants enrolled in the Preterm Erythropoietin (Epo) Neuroprotection Trial (PENUT).
This is a post hoc analysis of a randomized trial that enrolled infants born at 24-28 completed weeks of gestation. All infants in PENUT who were assessed with BSID-III at 2 years were included in this study. The associations between enteral iron dose at 60 and 90 days and BSID-III component scores were evaluated using generalized estimating equations models adjusted for potential confounders.
In total, 692 infants were analyzed (355 placebo, 337 Epo). Enteral iron supplementation ranged from 0 to 14.7 mg/kg/d (IQR 2.1-5.8 mg/kg/d) at day 60, with a mean of 3.6 mg/kg/d in infants treated with placebo and 4.8 mg/kg/d in infants treated with Epo. A significant positive association was seen between BSID-III cognitive scores and iron dose at 60 days, with an effect size of 0.77 BSID points per 50 mg/kg increase in cumulative iron dose (P = .03). Greater iron doses were associated with greater motor and language scores but did not reach statistical significance. Results at 90 days were not significant. The effect size in the infants treated with Epo compared with placebo was consistently greater.
A positive association was seen between iron dose at 60 days and cognitive outcomes. Our results suggest that increased iron supplementation in infants born preterm, at the doses administered in the PENUT Trial, may have positive neurodevelopmental effects, particularly in infants treated with Epo.
Clinicaltrials.gov: NCT01378273.
通过婴儿发育量表第三版（BSID-III）评估，检验在接受早产儿促红细胞生成素（Epo）神经保护试验（PENUT）的婴儿中，增加铁剂量是否与神经发育改善相关。
这是一项随机试验的事后分析，纳入了妊娠 24-28 周完成的婴儿。所有在 PENUT 中接受 2 年 BSID-III 评估的婴儿都包含在这项研究中。使用广义估计方程模型，在调整了潜在混杂因素后，评估 60 天和 90 天肠内铁剂量与 BSID-III 各成分评分之间的相关性。
共分析了 692 名婴儿（安慰剂组 355 名，Epo 组 337 名）。60 天时肠内铁补充剂范围为 0 至 14.7mg/kg/d（IQR 2.1-5.8mg/kg/d），安慰剂组婴儿的平均剂量为 3.6mg/kg/d，Epo 组婴儿的平均剂量为 4.8mg/kg/d。BSID-III 认知评分与 60 天时的铁剂量呈显著正相关，累积铁剂量每增加 50mg/kg，BSID 评分增加 0.77 分（P=.03）。较大的铁剂量与较大的运动和语言评分相关，但未达到统计学意义。90 天时的结果无统计学意义。Epo 组与安慰剂组相比，其铁剂量的效应大小始终更大。
60 天时铁剂量与认知结果之间存在正相关。我们的研究结果表明，在接受 PENUT 试验剂量的铁补充剂的早产儿中增加铁补充可能具有积极的神经发育效果，特别是在接受 Epo 治疗的婴儿中。
Clinicaltrials.gov：NCT01378273。
