Using intranasal breast milk to help preterm infants
: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
NA · Selcuk University · NCT06706115
This study is testing if giving breast milk through the nose can help preterm infants improve their brain health and feeding times.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 28 Weeks to 37 Weeks |
| Sex | All |
| Sponsor | Selcuk University (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Konya) |
| Trial ID | NCT06706115 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients who are able to feed orally in all feedings or are entirely formula-fed will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve brain health and feeding outcomes in preterm infants.
How similar studies have performed: There is emerging evidence from recent studies suggesting that intranasal breast milk administration may be effective, indicating a promising area of research.
Eligibility criteria
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 this trial is running
Konya
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Newborn, Vitality, Nursing Caries, Breast Feeding, Breast milk, Newborn Nursing, Oral Nutrition, Physiological parameters