Using intranasal breast milk to help preterm infants
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
Run by Selcuk University · NCT06706115 · Data updated 2026-11-12
This study is testing if giving breast milk through the nose can help preterm infants improve their brain health and feeding times.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 28 Weeks to 37 Weeks |
| Sex | All |
| Enrollment | 40 (estimated) |
| Sponsor | Selcuk University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Konya) |
| Status | Recruiting |
| Started | June 30, 2024 |
| Main results expected | September 15, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | November 26, 2024 |
| Trial ID | NCT06706115 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are preterm infants with a birth weight greater than 1000 grams and an APGAR score above 7 at 5 minutes after birth.
✕Probably not a fit
Patients who are able to feed orally in all feedings or are entirely formula-fed will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the effects of administering breast milk intranasally to preterm infants to assess its impact on cerebral oxygenation levels, vital signs, and the time taken to achieve full oral feeding. The approach leverages the potential of breast milk, which contains pluripotent stem cells, to enhance brain health by facilitating the transport of beneficial cells and molecules through the nasal vasculature. Previous studies suggest that this method may help reduce cerebral damage in preterm infants following intracranial hemorrhage and is generally well-tolerated by this population.
Why it matters
Potential benefit: If successful, this approach could improve brain health and feeding outcomes in preterm infants.
How similar studies have gone: There is emerging evidence from recent studies suggesting that intranasal breast milk administration may be effective, indicating a promising area of research.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Selcuk University
Konya, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Sibel Kucukoglu, Prof — Selcuk University
- Study coordinator: Sibel Kucukoglu, Prof
- Email: s_nadaroglu@hotmail.com
- Phone: +903322230789
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.