Intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage: Safety, feasibility and short-term outcomes

DENVER, April 22, 2022 – A new study demonstrates that intranasal human milk is a safe and feasible intervention for intraventricular hemorrhage, a serious cause of morbidity in preterm infants. Findings from the study will be presented during the Pediatric Academic Societies (PAS) 2022 Meeting, taking place April 21-25 in Denver. This is the first prospective trial on safety and feasibility of intranasal human milk administration in neonates with intraventricular hemorrhage.

 

Intraventricular hemorrhage is a common cause of brain injury with potential resultant neurodevelopmental sequalae for preterm infants. Stem cell therapies are being developed as a novel brain injury treatment. Fresh human milk contains pluripotent stem cells that produce neuronal cells in vitro. Animal models of neonatal brain injury have found milk stem cells in brain tissue of suckling mice with neuroprotective effects. Nasal vascularity and the permeable neonatal blood brain barrier potentially allow stem cell delivery to brain tissue via fresh intranasal human milk administration.

 

"Our study, ‘Intranasal Human Milk as Stem Cell Therapy in Preterm Infants with Intraventricular Hemorrhage: Safety, Feasibility and Short-Term Outcomes,’ attempts to harness the power of fresh human milk, which has stem cells and growth factors, as an intervention for very preterm babies with brain bleeds, a condition currently with no effective therapy,” said Alessia Gallipoli, MD, neonatal-perinatal medicine fellow at the University of Toronto. “Our prospective trial in Toronto, the first in the world, showed that these preterm infants were able to tolerate nasal milk therapy through 28 days of life without major safety events. We hope to use this preliminary data to plan a larger trial to gain more information on the effect of intranasal breastmilk on short- and long-term outcomes for this patient population."

 

Short-term outcomes are currently being compared to a historical control. Next steps will explore long-term neurodevelopmental outcomes at 18 months to plan for larger multicenter trials.

 

Dr. Gallipoli will present “Intranasal Human Milk as Stem Cell Therapy in Preterm Infants with Intraventricular Hemorrhage: Safety, Feasibility and Short-Term Outcomes” on Saturday, April 23 at 10:15 a.m. MDT. Reporters interested in an interview with Dr. Gallipoli should contact PAS2022@piercom.com.

 

The PAS Meeting connects thousands of pediatricians and other health care providers worldwide. For more information about the PAS Meeting, please visit www.pas-meeting.org.

 

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About the Pediatric Academic Societies Meeting

The Pediatric Academic Societies (PAS) Meeting is the premier North American scholarly child health meeting. The PAS Meeting connects thousands of pediatricians and other health care providers worldwide. The PAS Meeting is produced through a partnership of four pediatric organizations that are leaders in the advancement of pediatric research and child advocacy: American Pediatric Society, Society for Pediatric Research, Academic Pediatric Association and American Academy of Pediatrics. For more information, please visit www.pas-meeting.org. Follow us on Twitter @PASMeeting, Instagram PASMeeting and #PAS2022, and like us on Facebook PASMeeting. 

 

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Abstract: Intranasal Human Milk as Stem Cell Therapy in Preterm Infants with Intraventricular Hemorrhage: Safety, Feasibility and Short-Term Outcomes

 

Topic

Breastfeeding/Human Milk

 

Presenting Author

Alessia Gallipoli, MD

 

Organization

University of Toronto Temerty Faculty of Medicine

 

Background

Intraventricular hemorrhage (IVH) is a common cause of brain injury with potential resultant neurodevelopmental sequalae for preterm infants. Stem cell (SC) therapies are being developed as a novel brain injury treatment. Fresh human milk (HM) contains pluripotent SCs that produce neuronal cells in vitro. Animal models of neonatal brain injury have found milk SCs in brain tissue of suckling mice with neuroprotective effects. Nasal vascularity and the permeable neonatal blood brain barrier potentially allow SC delivery to brain tissue via fresh intranasal HM (IHM) administration. This is the first prospective trial on safety and feasibility of IHM administration in neonates with IVH.

 

Objective

To determine the safety and feasibility of IHM administration and to describe the frequency of short-term adverse clinical outcomes compared with historical controls.

 

Design/Methods

Recruitment took place at two tertiary care NICUs in Toronto. Infants < 33 weeks gestation with IVH diagnosed in the first 10 days of age with a parent who planned to lactate were eligible. An initial HM dose of 0.2 ml into one nostril was administered within 3 hours of pumping by a trained nurse or respiratory therapist. If tolerated, the dose was increased to 0.4mL given before and after nursing care, ideally twice daily for a goal of 1.6mL/day. Records of tolerance and adverse effects were collected for each administration. Short-term morbidity data on infants (post hemorrhagic ventricular dilation [PHVD], need for lumbar puncture (LP), shunt/reservoir, cystic changes on imaging) were collected and will be compared (not powered) to a historical HM fed cohort from the year prior. Administering providers were surveyed to determine acceptability and feasibility.

 

Results

Table 1 shows patient (n=37) characteristics and IHM dosing. Six infants required LPs for PHVD; 1 of these later required a shunt. There were no major safety events. 162 provider surveys (Table 2) from 34 patients were collected suggesting acceptability, although potential provider and subject stress requires further study. Historical cohort analysis is underway.

 

Conclusion(s)

This phase 1 study demonstrated that IHM is a safe and feasible intervention for IVH, a serious cause of morbidity in preterm infants. Short-term outcomes are currently being compared to a historical control. Next steps will explore long-term neurodevelopmental outcomes at 18 months to plan for larger multicentre trials.

 

Tables and Images

Table 1: Patient Characteristics and IHM Dosing Information

IVH: Intraventricular hemorrhage; IHM: intranasal human milk

Table 2: Clinical Provider Survey Results

HM: human milk; NICU: neonatal intensive care unit; (1) survey answer options: yes/no; (2) survey answer options: strongly agree/agree/neutral/disagree/strongly disagree

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