AbstractObjectiveIntraventricular 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.Study designInfants <33 weeks gestation with IVH were given IHM until maximum 28 days of age.

摘要目的脑室出血（IVH）是早产儿脑损伤的常见原因。新鲜人乳（HM）含有干细胞（SCs），可能通过鼻内HM（IHM）递送。在这项IHM试点研究中，我们描述了结果。研究设计妊娠33周以下的IVH婴儿接受IHM治疗，直至最大28天。

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.Result37 infants (35.1% grade 3-4 IVH) were compared to 191 historic controls (17.8% grade 3-4 IVH).

将短期神经系统结果和随访测试与历史上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计算量化了治疗效果。倾向评分模型计算IVH等级，胎龄和性别的逆概率权重。结果37名婴儿（35.1%为3-4级IVH）与191名历史对照（17.8%为3-4级IVH）进行了比较。

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.ConclusionThis phase 1 study suggests powered trials of IHM for brain injury are needed.Clinical Trial Registry Nameclinicaltrials.gov identifier NCT04225286.

出血后心室扩张很常见（IHM患者占25.7%）。大多数加权结果虽然不显着，但有利于4-12个月和18个月校正年龄的IHM。结论这项1期研究表明，需要IHM治疗脑损伤的动力试验。临床试验注册名称clinicaltrials.gov标识符NCT04225286。

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Download referencesAcknowledgementsWe are grateful to the families who participated, as well as the bedside nursing, medical, and respiratory staff who made this study possible during the pandemic.FundingFunding for this project was obtained through The New Frontiers in Research Fund – Exploration Grant 2018, Canadian Tri-Agencies (grant ID NFRFE-2018-01610).Author informationAuthors and AffiliationsDivision of Neonatology, The Hospital for Sick Children, Toronto, ON, CanadaAlessia Gallipoli, Amr El Shahed, Diane Wilson & Rebecca HobanDepartment of Paediatrics, Izaak Walton Killam Hospital, Halifax, NS, CanadaSharon UngerUniversity of Toronto, Toronto, ON, CanadaAmr El ShahedTed Rogers Computational Program, Peter Munk Cardiac Centre, University Health Network, Toronto, ON, CanadaChun-Po Steve Fan & Marisa SignorileDivision of Neonatology, Seattle Children’s Hospital, Seattle, WA, USARebecca HobanUniversity of Washington, Seattle, WA, USARebecca HobanAuthorsAlessia GallipoliView author publicationsYou can also search for this author in.

下载参考文献致谢我们感谢参与研究的家庭，以及在大流行期间使这项研究成为可能的床边护理，医疗和呼吸工作人员。资助该项目的资金是通过加拿大Tri机构的新前沿研究基金-2018年勘探资助（资助ID NFRFE-2018-01610）获得的。作者信息作者和附属机构新生儿科，多伦多病童医院，安大略省，加拿大加利波利，阿默尔·沙赫德，黛安·威尔逊和丽贝卡·霍班德儿科，伊扎克·沃尔顿·基勒姆医院，哈利法克斯，NS，加拿大多伦多大学，多伦多，安大略省，加拿大阿默尔·沙赫德·罗杰斯计算程序，Peter Munk心脏中心，大学卫生网络，多伦多，安大略省，加拿大达春Po Steve Fan和Marisa SignorileDivision of Neonatology，西雅图儿童医院，西雅图，华盛顿州，美国丽贝卡·霍班纳大学，华盛顿州西雅图，USAREBCCA HobanAuthorsAlessia GALLIPLIVIEW作者出版物您也可以在中搜索这位作者。

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PubMed Google ScholarContributionsRH was responsible for conceptualization, funding acquisition, methodology, project administration, supervision, investigation, data collection, and writing (both original draft and review/editing). AG, a trainee at the time of the study, was responsible for data collection, data visualization, and writing (both original draft and review/editing).

PubMed Google ScholarContributionsRH负责概念化，资金获取，方法论，项目管理，监督，调查，数据收集和写作（原稿和评论/编辑）。AG是研究时的实习生，负责数据收集，数据可视化和写作（原始草案和审查/编辑）。

SU was responsible for funding acquisition, supervision, investigation, data collection, and writing (review/editing). AES and DW were responsible for funding acquisition, investigation, data collection, and writing (review/editing). SF and MS provided computing resources and software, statistical methodology and formal analysis, and writing (both original draft and review/editing).Corresponding authorCorrespondence to.

SU负责资金获取，监督，调查，数据收集和写作（审查/编辑）。AE和DW负责资金获取，调查，数据收集和撰写（审查/编辑）。SF和MS提供了计算资源和软件，统计方法和正式分析，以及写作（原稿和评论/编辑）。对应作者对应。

Rebecca Hoban.Ethics declarations

丽贝卡·霍班。道德宣言

Competing interests

相互竞争的利益

The authors have no conflicts of interest relevant to this article to disclose. RH is currently on the clinical advisory board for Medela America (was not on the board during this study.)

。RH目前是Medela America临床咨询委员会的成员（在本研究期间不在委员会中）

Consent to participate statement

同意参与声明

Written informed consent was obtained from the guardian of eligible participants prior to participation in the intervention portion of the study.

在参与研究的干预部分之前，从合格参与者的监护人那里获得了书面知情同意书。

Ethics approval

This study protocol was reviewed and approved by Clinical Trials Ontario, project ID 1911.

该研究方案已由安大略省临床试验项目ID 1911审查和批准。

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et al. Outcomes after intranasal human milk therapy in preterm infants with intraventricular hemorrhage..

等。早产儿脑室内出血鼻内人乳治疗后的结果。。

J Perinatol (2024). https://doi.org/10.1038/s41372-024-02147-3Download citationReceived: 24 September 2024Revised: 27 September 2024Accepted: 01 October 2024Published: 09 October 2024DOI: https://doi.org/10.1038/s41372-024-02147-3Share this articleAnyone you share the following link with will be able to read this content:Get shareable linkSorry, a shareable link is not currently available for this article.Copy to clipboard.

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