Feasibility and Safety of Intranasally Administered Breast Milk in HIE

NCT06747260 | Recruiting Early Phase 1

• 1 other identifier: SE-NEONAT-03/2024
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypoxic Ischaemic Encephalopathy (HIE); Hypoxic Ischemic Encephalopathy of Newborn; Neonatal Encephalopathy; Neonatal Hypoxic Ischemic Encephalopathy; Brain Injury; Perinatal Asphyxia; Perinatal Asphyxia , Moderate to Severe HIE

Keywords

Hypoxic-ischaemic encephalopathy; Neonatal encephalopathy; Perinatal asphyxia; Breast milk; Breast milk stem cells; Intranasal breast milk

Outcome Measures

Primary Outcomes (1)

• Proportion of patients where treatment was initiated within 48 hours

  Feasibility will be based on the ability to initiate treatment within 48 hours of birth using own mother's fresh milk.

  1 months

Secondary Outcomes (4)

• Number of adverse events associated with breast milk administration

  1 month

• Time to reach full enteral feeding

  1 month

• Length of exclusive breast feeding

  2 years

• Total number of treatments during first months of life

  1 months

Study Arms (1)

Intranasal breast milk

EXPERIMENTAL

Study participants receive their own mother's fresh breast milk, expressed within 4 hours, administered 2 times daily, 0.4 ml in each nostril for 28 days.

Biological: Intranasal breast milk

Interventions

Intranasal breast milk BIOLOGICAL

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).

Intranasal breast milk

Eligibility Criteria

• Age: Up to 48 Hours
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Moderate or severe hypoxic- ischaemic encephalopathy, receiving therapeutic hypothermia
• ≥ 35. gestational week
• \< 48 hours of life
• Hypothermia treatment for 72 hours
• Parental consent form

You may not qualify if:

• Congenital malformation
• Concurrent cerebral lesions
• ECMO therapy
• Contraindication of lactation
• Mother unable or unwilling to provide fresh breast milk
• Postpartum asphyxia

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary

Budapest, 1083, Hungary

RECRUITING

Related Publications (3)

• 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 Netherlands (PASSIoN): a first-in-human, open-label intervention study. Lancet Neurol. 2022 Jun;21(6):528-536. doi: 10.1016/S1474-4422(22)00117-X.

  PMID: 35568047 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Unoke Meder, MD, PhD

  Department of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Unoke Meder, MD, PhD

CONTACT

+36303987970; mederunoke@gmail.com

Agnes Jermendy, MD, PhD

CONTACT

+36204600798; jermendy@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2024
• First Posted: December 24, 2024
• Study Start: November 22, 2024
• Primary Completion: September 22, 2025
• Study Completion (Estimated): January 1, 2030
• Last Updated: May 22, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 20.12.2024.-01.01.2026.
• Access Criteria: Sharing upon reasonable request.

Locations

HU (1)