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

IF 2.4 3区医学 Q2 OBSTETRICS & GYNECOLOGY

Journal of Perinatology Pub Date : 2024-10-09 DOI:10.1038/s41372-024-02147-3

Alessia Gallipoli, Sharon Unger, Amr El Shahed, Chun-Po Steve Fan, Marisa Signorile, Diane Wilson, Rebecca Hoban

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Abstract

Objective: 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.

Study design: 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.

Result: 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.

Conclusion: This phase 1 study suggests powered trials of IHM for brain injury are needed. CLINICAL TRIAL REGISTRY NAME: clinicaltrials.gov identifier NCT04225286.

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早产儿脑室内出血鼻内人乳疗法后的疗效。

目的：脑室内出血（IVH）是早产儿脑损伤的常见原因。新鲜母乳（HM）中含有干细胞（SCs），可通过鼻内HM（IHM）输送。在这项IHM试点研究中，我们描述了研究结果：结果：37名婴儿（35.1%为3-4级IVH）与191名历史对照组（17.8%为3-4级IVH）进行了比较。出血后心室扩张很常见（25.7% 的 IHM 患者）。大多数加权结果虽然不显著，但在4-12个月和18个月矫正年龄时更倾向于IHM：这项 1 期研究表明，需要对治疗脑损伤的 IHM 进行有动力的试验。临床试验注册名称：clinicaltrials.gov 识别码 NCT04225286。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Journal of Perinatology 医学-妇产科学

CiteScore

5.40

自引率

6.90%

发文量

284

审稿时长

3-8 weeks

期刊介绍： The Journal of Perinatology provides members of the perinatal/neonatal healthcare team with original information pertinent to improving maternal/fetal and neonatal care. We publish peer-reviewed clinical research articles, state-of-the art reviews, comments, quality improvement reports, and letters to the editor. Articles published in the Journal of Perinatology embrace the full scope of the specialty, including clinical, professional, political, administrative and educational aspects. The Journal also explores legal and ethical issues, neonatal technology and product development. The Journal’s audience includes all those that participate in perinatal/neonatal care, including, but not limited to neonatologists, perinatologists, perinatal epidemiologists, pediatricians and pediatric subspecialists, surgeons, neonatal and perinatal nurses, respiratory therapists, pharmacists, social workers, dieticians, speech and hearing experts, other allied health professionals, as well as subspecialists who participate in patient care including radiologists, laboratory medicine and pathologists.