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

期刊论文
发表日期：

2024年10月9日

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

摘要

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