Effect of Intranasal Breast Milk Administration in Preterm Infants

Официальное название

: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study

Обзор

The aim of the study was to investigate the effect of intranasal breast milk administration on cerebral oxygenation level, vital signs and time to full oral feeding in preterm infants.

Подробное описание

Breast milk is rich in pluripotent stem cells, including pluripotent stem cells that produce neuronal cells in vitro. Therefore, intranasal breast milk administration in neonates may potentially allow the transport of stem cells and other molecules into brain tissue through the nasal vasculature and permeable neonatal blood-brain barrier. In recent years, studies on intranasal breast milk administration in newborns have been published. In studies, there is evidence that intranasal breast milk may be effective in reducing cerebral damage after intracranial hemorrhage in preterm newborns and that the application can be tolerated by preterm newborns.

Вмешательства

• Другое Intranasal human breast milk
  The information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Fol

Первичные конечные точки

• Infant Information Form [Срок оценки: First measurement-First day of hospitalization]
• Physiologic Parameter Follow-up Form-Cerebral rSO2 [Срок оценки: First measurement- 5 minutes before the intervention (T0)]
• Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2) [Срок оценки: First measurement- 5 minutes before the intervention (T0)]
• Physiologic Parameter Follow-up Form-Heart Rate (HR) [Срок оценки: First measurement- 5 minutes before the intervention (T0)]
• Physiologic Parameter Follow-up Form-Respiratory rate [Срок оценки: First measurement- 5 minutes before the intervention (T0)]
• Nutrition Follow-up Form-intranasal breast milk content [Срок оценки: First measurement- intranasal breast milk content]

Вторичные конечные точки (12)

• Physiologic Parameter Follow-up Form -Cerebral rSO2 [Срок оценки: Second measurement- 5. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Cerebral rSO2 [Срок оценки: Second measurement- 15. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Cerebral rSO2 [Срок оценки: Second measurement- 30. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Срок оценки: Second measurement- 5. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Срок оценки: Second measurement- 15. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Срок оценки: Second measurement- 30. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Heart Rate (HR) [Срок оценки: Second measurement- 5. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Heart Rate (HR) [Срок оценки: Second measurement- 15. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Heart Rate (HR) [Срок оценки: Second measurement- 30. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Respiratory rate [Срок оценки: Second measurement- 5. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Respiratory rate [Срок оценки: Second measurement- 15. minutes after the intervention (T1)]
• Physiologic Parameter Follow-up Form -Respiratory rate [Срок оценки: Second measurement- 30. minutes after the intervention (T1)]

Критерии участия

Критерии включения

• Birth weight >1000 gr,
• APGAR score >7 at 5 minutes after birth,
• Availability of breast milk,
• No medical diagnosis affecting cerebral oxygenation (intraventricular hemorrhage, cardiovascular and neurological disorders, anemia),
• No congenital anomalies or chromosomal abnormalities,
• No congenital anomaly (such as cleft palate) affecting nasal patency.

Критерии исключения

• Being able to feed orally in all feedings
• Being fed entirely on formula milk,
• Administration of medication via the nasal route,
• Being intubated or receiving continuous positive air pressure (CPAP) support,
• Maternal substance abuse, alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment,
• The mother has mastitis, breast trauma, abscesses or is taking any medication that passes into the milk,
• The mother does not want to express milk.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Turkey (Türkiye) · 1 центр

• Selcuk University — Konya

Публикации

• 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
• 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
• Muelbert M, Alexander T, Pook C, Jiang Y, Harding JE, Bloomfield FH. Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study. Nutrients. 2021 Jan 25;13(2):350. doi: 10.3390/nu13020350. PMID 33503882
• Yucel A, Kucukoglu S, Soylu H. The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial. Biol Res Nurs. 2024 Jan;26(1):160-175. doi: 10.1177/10998004231200784. Epub 2023 Sep 8. PMID 37682253
• Yucel A, Kucukoglu S, Konak M. Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study. Eur J Pediatr. 2026 Apr 16;185(5):272. doi: 10.1007/s00431-026-06922-6. PMID 41986747
• Yucel A, Kucukoglu S, Konak M. The Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Time to Full Oral Feeding in Preterm Infants: a Randomised Controlled Study Protocol. Nurs Crit Care. 2026 Jan;31(1):e70262. doi: 10.1111/nicc.70262. PMID 41542903

Идентификаторы

NCT: NCT06706115 · SelcukUni2545

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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