Intranasal Breast Milk Therapy in HIE

NCT06746532 | Recruiting Early Phase 1

• 1 other identifier: NNGYK/40202-5/2024
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label prospective single-center randomized controlled trial to evaluate the effect of intranasal breast milk in hypoxic-ischemic encephalopathic neonates receiving therapeutic hypothermia on long term neurodevelopmental outcome compared to standard care.

Conditions

Hypoxic-Ischaemic Encephalopathy; Neonatal Encephalopathy; Perinatal Asphyxia; Neonatal Hypoxic Ischemic Encephalopathy

Keywords

HIE; intranasal breast milk; perinatal asphyxia; brain; breast milk stem cells; hypoxic-ischemic encephalopathy

Outcome Measures

Primary Outcomes (1)

• Neurodevelopmental outcome

  The primary outcome will be the 2 year neurodevelopmental outcome comparing standard care and intranasal breast milk therapy groups. The Bayley Scales of Infant Development, Third Edition (Bayley-III) score will be used to assess neurodevelopmental outcome, favorable outcome is defined as having composite scores for cognitive, language and motor scales \>85, while adverse outcome is defined as composite scores \<80 or death.

  2 years

Secondary Outcomes (2)

• Time to reach full enteral feeding

  1 month

• Length of exclusive breast feeding

  2 years

Study Arms (2)

Control

NO INTERVENTION

Standard care for moderate or severe hypoxic-ischemic encephalopathy with hypothermia.

Intranasal breast milk

EXPERIMENTAL

Fresh own mother's breast milk expressed within 4 hours, will be administered 2 times daily, 0.4 ml in each nostril for 28 days.

Biological: Intranasal breast milk

Interventions

Intranasal breast milk BIOLOGICAL

Own-mother's fresh breast milk (within 4 hours of having been expressed), is administered intranasally to neonates with hypoxic-ischemic encephalopathy receiving therapeutic hypothermia, starting from the first day of life and continuing for 28 days. Dose: 2 times daily, 0.4 ml in each nostril.

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- ischemic 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)

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

Budapest, 1083, Hungary

RECRUITING

Related Publications (4)

• Chen Y, Zhang C, Huang Y, Ma Y, Song Q, Chen H, Jiang G, Gao X. Intranasal drug delivery: The interaction between nanoparticles and the nose-to-brain pathway. Adv Drug Deliv Rev. 2024 Apr;207:115196. doi: 10.1016/j.addr.2024.115196. Epub 2024 Feb 7.

  PMID: 38336090 BACKGROUND

• 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

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

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 24, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: December 24, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 20.12.2024.-01.01.2030.
• Access Criteria: On special request pending data transfer agreement approval by Semmelweis University. Sharing upon reasonable request.

Locations

HU (1)