Feasibility and Safety of Intranasally Administered Breast Milk in HIE
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intranasal breast milk.
- Who it may be relevant to
- Registry conditions: Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy. Basic parameters: up to 48 Hours · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Hungary
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Feasibility and Safety of Intranasal Breast Milk in Hypoxic-ischaemic Encephalopathy
Overview
This is a prospective intervention single center study to evaluate the feasibility and safety of intranasal breast milk in hypoxic-ischaemic encephalopathic neonates receiving therapeutic hypothermia.
Detailed description
Perinatal asphyxia and the resulting hypoxic-ischemic encephalopathy (HIE) are the leading cause of neonatal mortality and long-term neurodevelopmental disabilities. Based on our current knowledge, therapeutic hypothermia is the only therapy that has been proven to reduce central nervous system damage in HIE neonates. Improving neurodevelopmental outcomes of newborns with HIE has been an intense area of research over the past decade.
Breast milk is a complex biological substance that contains a variety of bioactive components including neurotrophic growth factors, cytokines, immunoglobulins, and multipotent stem cells. Studies have shown that exclusive breastfeeding in the early stages of development has a positive impact on cognitive outcomes. Animal studies support that mesenchymal stem cells and neurotrophic substances found in breast milk, when administered intranasally enter the central nervous system and reduce the extent of neurological damage. In preterm infants, it has been shown that intranasally administered breast milk is safe and well-tolerated.
In this prospective study our aim is to assess the feasibility and safety of intranasally delivered breast milk to HIE infants treated with hypothermia. Our objective is to administer fresh, own-mother's breast milk intranasally to neonates with HIE starting from the first day of life and continuing for 1 month.
Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk expressed within 4 hours and continuing treatment after discharge until day 28. Safety will be assessed through monitoring vital signs and documenting any adverse events. Time to reach full enteral feeding and lengths of exclusive breast feeding will be recorded and analyzed.
Interventions
- Biological Intranasal breast milk
Neonates with hypoxic-ischemic encephalopathy receive their own-mother's fresh breast milk intranasally, starting from the first 48 hours of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril (15 minutes apart).
Primary outcome measures
- Proportion of patients where treatment was initiated within 48 hours [Time frame: 1 months]
Secondary outcome measures (4)
- Number of adverse events associated with breast milk administration [Time frame: 1 month]
- Time to reach full enteral feeding [Time frame: 1 month]
- Length of exclusive breast feeding [Time frame: 2 years]
- Total number of treatments during first months of life [Time frame: 1 months]
Eligibility criteria
Inclusion criteria
- Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
- ≥ 35. gestational week
- < 48 hours of life
- Hypothermia treatment for 72 hours
- Parental consent form
Exclusion criteria
- Congenital malformation
- Concurrent cerebral lesions
- ECMO therapy
- Contraindication of lactation
- Mother unable or unwilling to provide fresh breast milk
- Postpartum asphyxia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Hungary · 1 center
- Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary — Budapest
Publications
- Baak LM, Wagenaar N, van der Aa NE, Groenendaal F, Dudink J, Tataranno ML, Mahamuud U, Verhage CH, Eijsermans RMJC, Smit LS, Jellema RK, de Haan TR, Ter Horst HJ, de Boode WP, Steggerda SJ, Prins HJ, de Haar CG, de Vries LS, van Bel F, Heijnen CJ, Nijboer CH, Benders MJNL. Feasibility and safety of intranasally administered mesenchymal stromal cells after perinatal arterial ischaemic stroke in the PMID 35568047
- Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30. PMID 38688998
- Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1. PMID 30386923
Identifiers
NCT: NCT06747260 · SE-NEONAT-03/2024