Effect of Intranasal Breast Milk Administration in Preterm Infants

Last updated: November 22, 2024
Sponsor: Selcuk University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Feeding

Treatment

Intranasal human breast milk

Clinical Study ID

NCT06706115
SelcukUni2545
  • Ages 28-37
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

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

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 activetuberculosis, chemotherapy or radiotherapy treatment,

  • The mother has mastitis, breast trauma, abscesses or is taking any medication thatpasses into the milk,

  • The mother does not want to express milk.

Study Design

Total Participants: 40
Treatment Group(s): 1
Primary Treatment: Intranasal human breast milk
Phase:
Study Start date:
June 30, 2024
Estimated Completion Date:
December 30, 2025

Study 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.

Connect with a study center

  • Selcuk University

    Konya,
    Turkey

    Active - Recruiting

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