Evidence map›Paper›PMID 38688998›Full record

ArticleJournal of perinatology : official journal of the California Perinatal Association2024

Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage.

Rebecca Hoban, Alessia Gallipoli, Marisa Signorile, Poonam Mander, Andree Gauthier-Fisher, Clifford Librach, Diane Wilson, Sharon Unger

4 registry-linked trialsAbstract readClinical Trial, Phase I
PubMed Publisher
In one paragraph

Article in Journal of perinatology : official journal of the California Perinatal Association, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 4 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04225286 naunknown statusnot on this map

Intranasal Human Milk as Stem Cell Therapy in Preterm Infants With Intraventricular Hemorrhage

TypeinterventionalSponsorThe Hospital for Sick ChildrenRan2020 to 2023Enrolled37ConditionsIntraventricular HemorrhageArmsHuman breast milk
NCT06706115 narecruitingnot on this map

: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study

TypeinterventionalSponsorSelcuk UniversityRan2024 to 2025Enrolled40ConditionsNewborn, Vitality, Nursing Caries, Breast FeedingArmsIntranasal human breast milk
NCT06746532 early_phase1recruitingnot on this mapstarted 2025, after this paper: background citation

Neonatal Intranasal Breast Milk, Impact on Brain Growth in Hypoxic-ischemic Encephalopathy Therapy (NEO-BRIGHT)

TypeinterventionalSponsorSemmelweis UniversityRan2025 to 2030Enrolled80ConditionsHypoxic-Ischaemic Encephalopathy, Neonatal Encephalopathy, Perinatal Asphyxia, Neonatal Hypoxic Ischemic EncephalopathyArmsIntranasal breast milk
NCT06747260 early_phase1recruitingnot on this map

Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy

TypeinterventionalSponsorSemmelweis UniversityRan2024 to 2030Enrolled10ConditionsHypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic EncephalopathyArmsIntranasal breast milk
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Review
  6. Review
  7. Perinatal Neuroprotection in Preterm Birth.Geburtshilfe und Frauenheilkunde · 2025
    Article
  8. Review
  9. They will be famous: Multipotent stem cells in breast milk.World journal of clinical pediatrics · 2025
    Review
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Rebecca HobanDivision of Neonatology, The Hospital for Sick Children/University of Toronto, Toronto, ON, Canada. rebecca.hoban@seattlechildrens.org.ORCID 0000-0001-9457-8791
Alessia GallipoliDivision of Neonatology, The Hospital for Sick Children/University of Toronto, Toronto, ON, Canada.
Marisa SignorileTed Rogers Computational Program, Peter Munk Cardiac Centre, University Health Network, Toronto, ON, Canada.
Poonam ManderCReATe Fertility Centre, Toronto, ON, Canada.
Andree Gauthier-FisherCReATe Fertility Centre, Toronto, ON, Canada.
Clifford LibrachCReATe Fertility Centre, Toronto, ON, Canada.
Diane WilsonDivision of Neonatology, The Hospital for Sick Children/University of Toronto, Toronto, ON, Canada.
Sharon UngerDepartment of Paediatrics, Izaak Walton Killam Hospital, Halifax, NS, Canada.ORCID 0000-0001-8091-5742

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveIntraventricular hemorrhage (IVH) is a common cause of preterm brain injury. Fresh parent's own milk (POM) contains pluripotent stem cells (SCs) that produce neuronal cells in-vitro. The permeable neonatal blood brain barrier potentially allows SC delivery. We performed the first prospective trial (clinicaltrials.gov NCT04225286) of feasibility of intranasal POM (IPOM) in preterm infants with IVH and described SC content of POM samples. STUDY

design37 Infants (mean gestation 27.7 ± 2.6 weeks, birthweight 1030 ± 320 g) with IVH (35.1% grade IV) were recruited from two tertiary Toronto NICUs. IPOM was given ideally twice daily until 28 days of age. Tolerance and adverse reactions were collected and 162 administering providers surveyed.

resultsThere were no major adverse reactions. Provider surveys suggested acceptability, although potential provider and subject stress requires further study. Milk cell analysis suggests wide variability between parents.

conclusionsThis phase 1 study demonstrated IPOM was tolerated and feasible in preterm infants.

Indexed as

Administration, IntranasalFeasibility StudiesInfant, PrematureMilk, HumanCerebral HemorrhageCerebral Intraventricular HemorrhageFemaleHumansInfant, NewbornInfant, Premature, DiseasesIntensive Care Units, NeonatalMaleProspective StudiesStem Cell Transplantation

Identifiers

What Socratic holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.