Gallipoli Alessia, Unger Sharon, El Shahed Amr, Fan Chun-Po Steve, Signorile Marisa, Wilson Diane, Hoban Rebecca
Division of Neonatology, The Hospital for Sick Children, Toronto, ON, Canada.
Department of Paediatrics, Izaak Walton Killam Hospital, Halifax, NS, Canada.
J Perinatol. 2025 Feb;45(2):202-207. doi: 10.1038/s41372-024-02147-3. Epub 2024 Oct 9.
Intraventricular hemorrhage (IVH) is a common cause of brain injury in preterm infants. Fresh human milk (HM) contains stem cells (SCs) that could potentially be delivered via intranasal HM (IHM). In this IHM pilot study, we describe outcomes.
Infants <33 weeks gestation with IVH were given IHM until maximum 28 days of age. Short-term neurologic outcomes and follow-up testing were compared to historic HM-fed infants. Longitudinal outcomes were plotted using linear mixed models. Weighted G-computation quantified treatment effects. Propensity score models calculated inverse probability weights for IVH grade, gestational age, and sex.
37 infants (35.1% grade 3-4 IVH) were compared to 191 historic controls (17.8% grade 3-4 IVH). Post-hemorrhagic ventricular dilatation was common (25.7% IHM patients). Most weighted outcomes, although not significant, favored IHM at 4-12 and 18 months corrected age.
This phase 1 study suggests powered trials of IHM for brain injury are needed. CLINICAL TRIAL REGISTRY NAME: clinicaltrials.gov identifier NCT04225286.
脑室内出血(IVH)是早产儿脑损伤的常见原因。新鲜人乳(HM)含有干细胞(SCs),可通过鼻内给予人乳(IHM)来输送。在这项IHM初步研究中,我们描述了研究结果。
对孕周<33周且患有IVH的婴儿给予IHM,直至最大28日龄。将短期神经学结果和随访测试与历史上接受HM喂养的婴儿进行比较。使用线性混合模型绘制纵向结果。加权G计算量化治疗效果。倾向评分模型计算IVH分级、孕周和性别的逆概率权重。
将37例婴儿(35.1%为3-4级IVH)与191例历史对照(17.8%为3-4级IVH)进行比较。出血后脑室扩张很常见(25.7%的IHM患者)。大多数加权结果,尽管不显著,但在矫正年龄4-12个月和18个月时有利于IHM。
这项1期研究表明,需要对IHM治疗脑损伤进行有足够样本量的试验。临床试验注册名称:clinicaltrials.gov标识符NCT04225286。