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Clinical Trial
. 2025 Feb;45(2):202-207.
doi: 10.1038/s41372-024-02147-3. Epub 2024 Oct 9.

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

Alessia Gallipoli  1 , Sharon Unger  2 , Amr El Shahed  1   3 , Chun-Po Steve Fan  4 , Marisa Signorile  4 , Diane Wilson  1 , Rebecca Hoban  5   6   7
Affiliations
Clinical Trial

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

Alessia Gallipoli et al. J Perinatol. 2025 Feb.

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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Conflict of interest statement

Competing interests: 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.) Consent to participate statement: Written informed consent was obtained from the guardian of eligible participants prior to participation in the intervention portion of the study. Ethics approval: This study protocol was reviewed and approved by Clinical Trials Ontario, project ID 1911.

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