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Recruiting NCT06706115

Effect of Intranasal Breast Milk Administration in Preterm Infants

No phase Interventional Newborn; Vitality Nursing Caries Breast Feeding

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 human breast milk.
Who it may be relevant to
Registry conditions: Newborn; Vitality, Nursing Caries, Breast Feeding. Basic parameters: 28 Weeks — 37 Weeks · 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
Turkey (Türkiye)
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

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

Overview

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.

Detailed description

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.

Interventions

  • Other 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

Primary outcome measures

  • Infant Information Form [Time frame: First measurement-First day of hospitalization]
  • Physiologic Parameter Follow-up Form-Cerebral rSO2 [Time frame: First measurement- 5 minutes before the intervention (T0)]
  • Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2) [Time frame: First measurement- 5 minutes before the intervention (T0)]
  • Physiologic Parameter Follow-up Form-Heart Rate (HR) [Time frame: First measurement- 5 minutes before the intervention (T0)]
  • Physiologic Parameter Follow-up Form-Respiratory rate [Time frame: First measurement- 5 minutes before the intervention (T0)]
  • Nutrition Follow-up Form-intranasal breast milk content [Time frame: First measurement- intranasal breast milk content]
Secondary outcome measures (12)
  • Physiologic Parameter Follow-up Form -Cerebral rSO2 [Time frame: Second measurement- 5. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Cerebral rSO2 [Time frame: Second measurement- 15. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Cerebral rSO2 [Time frame: Second measurement- 30. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Time frame: Second measurement- 5. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Time frame: Second measurement- 15. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) [Time frame: Second measurement- 30. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Heart Rate (HR) [Time frame: Second measurement- 5. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Heart Rate (HR) [Time frame: Second measurement- 15. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Heart Rate (HR) [Time frame: Second measurement- 30. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Respiratory rate [Time frame: Second measurement- 5. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Respiratory rate [Time frame: Second measurement- 15. minutes after the intervention (T1)]
  • Physiologic Parameter Follow-up Form -Respiratory rate [Time frame: Second measurement- 30. minutes after the intervention (T1)]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Selcuk University — Konya

Publications

  • 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

Identifiers

NCT: NCT06706115 · SelcukUni2545

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗