Infants with symptomatic congenital cytomegalovirus infection (cCMV) suffer from long-term sequelae. This study aimed at evaluating the efficacy of combining immunoglobulin (Ig) fetal therapy (FT) and neonatal therapy (NT) with antiviral drugs to improve neurological outcomes of affected infants.

Women whose fetuses had symptomatic cCMV received Ig injection into the fetal peritoneal cavity and/or maternal blood as FT, while affected newborns received oral valganciclovir or intravenous ganciclovir as NT. We compared the neurological outcomes at ≥18 months old between infants receiving FT with or without NT (FT group) and those receiving NT only (NT group).

From 2009–2019, 15 women whose fetuses had symptomatic cCMV received FT, while 19 newborns received NT only. In FT group, two newborns died, and two were <18 months old. Neurological outcomes of the remaining 11 infants in FT group were as follows: normal 45.5 %, mild impairments 36.4 %, and severe impairments 18.2 %. In NT group, one newborn died, one’s parents refused the follow-up, one was <18 months old, and two had only chorioretinitis as symptoms. Neurological outcomes of the remaining 14 infants in NT group were as follows: normal 21.4 %, mild impairments 14.3 %, and severe impairments 64.3 %. The proportion of infants with severe impairments in FT group was significantly lower than that in NT group (18.2 % vs 64.3 %, p < 0.05).

This is the first trial demonstrating that the combination of Ig FT and NT with antiviral drugs may be more effective in improving neurological outcomes of newborns with symptomatic cCMV as compared to NT only.

有症状的先天性巨细胞病毒感染 (cCMV) 的婴儿患有长期后遗症。本研究旨在评估将免疫球蛋白 (Ig) 胎儿疗法 (FT) 和新生儿疗法 (NT) 与抗病毒药物相结合以改善受影响婴儿的神经系统结局的功效。

胎儿有症状性 cCMV 的妇女接受 Ig 注射到胎儿腹腔和/或母血作为 FT，而受影响的新生儿接受口服缬更昔洛韦或静脉注射更昔洛韦作为 NT。我们比较了接受 FT 伴或不伴 NT 的婴儿（FT 组）和仅接受 NT 的婴儿（NT 组）在≥18 个月大时的神经学结果。

从 2009 年到 2019 年，15 名胎儿有症状的 cCMV 的女性接受了 FT，而 19 名新生儿仅接受了 NT。FT组2例新生儿死亡，2例<18月龄。FT组其余11名婴儿的神经学结果如下：正常45.5%，轻度损伤36.4%，重度损伤18.2%。NT组1例新生儿死亡，1例父母拒绝随访，1例<18月龄，2例仅有脉络膜视网膜炎症状。NT组其余14名婴儿的神经学结果如下：正常21.4%，轻度损伤14.3%，重度损伤64.3%。FT组重度损伤婴儿比例显着低于NT组（18.2 % vs 64.3 %，p < 0.05）。

这是第一项试验，证明 Ig FT 和 NT 与抗病毒药物的组合可能比仅使用 NT 更有效地改善有症状的 cCMV 新生儿的神经系统结果。