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Идёт набор NCT06747260

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

Ранняя фаза I С лечением Hypoxic Ischaemic Encephalopathy (HIE) Hypoxic Ischemic Encephalopathy of Newborn Neonatal Encephalopathy Neonatal Hypoxic Ischemic Encephalopathy

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Intranasal breast milk.
Кому может быть актуально
Состояния в реестре: Hypoxic Ischaemic Encephalopathy (HIE), Hypoxic Ischemic Encephalopathy of Newborn, Neonatal Encephalopathy, Neonatal Hypoxic Ischemic Encephalopathy. Базовые параметры: до 48 Hours · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Венгрия
Следующий шаг
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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

  • Биопрепарат 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).

Первичные конечные точки

  • Proportion of patients where treatment was initiated within 48 hours [Срок оценки: 1 months]
Вторичные конечные точки (4)
  • Number of adverse events associated with breast milk administration [Срок оценки: 1 month]
  • Time to reach full enteral feeding [Срок оценки: 1 month]
  • Length of exclusive breast feeding [Срок оценки: 2 years]
  • Total number of treatments during first months of life [Срок оценки: 1 months]

Критерии участия

Критерии включения

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

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Венгрия · 1 центр
  • Division of Neonatology, Pediatric Center, Semmelweis University, Budapest, Hungary — Budapest

Публикации

  • 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

Идентификаторы

NCT: NCT06747260 · SE-NEONAT-03/2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗