Effect of Intranasal Breast Milk Administration in Preterm Infants

Selcuk University

Status: Enrolling

Conditions: Breast Feeding; Newborn; Vitality; Nursing Caries

Treatments: Other: Intranasal human breast milk

Study type: Interventional

Funder types: Other

Identifiers

NCT06706115

SelcukUni2545

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 28 to 37 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

40 participants in 2 patient groups

Intranasal Breast Milk Group

Experimental group

Description:

Preterm infants (28-37 gestation week) in the intervention group will receive 0.2 ml of breast milk intranasally three times a day for three days.

Treatment:

Other: Intranasal human breast milk

Control Group

No Intervention group

Description:

Preterm newborns in the control group will not receive any intervention.