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Clinical Trials in Turkey / NCT06706115
Recruiting Not applicable

Effect of Intranasal Breast Milk Administration in Preterm Infants

NCT06706115 · tracked via the Priya Life Science Turkey tracker
Phase
Not applicable
Started
2024-06-30
Last updated
2024-11-26

Condition(s) studied

Newborn; VitalityNursing CariesBreast Feeding

Investigational drug(s) / intervention(s)

Intranasal human breast milk

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 Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00).

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

Sex
ALL
Min age
28 Weeks
Max age
37 Weeks
Healthy volunteers
Accepted
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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Selcuk University Konya Turkey (Türkiye) Recruiting

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06706115 on ClinicalTrials.gov ↗ ← All trials in Turkey