Effect of intranasal breast milk administration on cerebral oxygenation, vital signs and transition time to full oral feeding in preterm infants: Randomized controlled stud

The first aim of the study was to investigate the effects of intranasal breast milk administration on cerebral oxygenation levels, vital signs, and the time required to transition to full oral feeding in preterm infants. The secondary aim of the study was to determine the effect of intranasal breast milk administration on the daily number of vomiting, daily number of defecations and discharge time of preterm infants. The study, which was a parallel group randomized controlled experimental design, was conducted between June 2024 and October 2025 in the Neonatal Intensive Care Unit of Selçuk University Medical Faculty Hospital in Konya. Study data were collected from 40 preterm infants between 28+0 and 36+6 weeks of gestation. Preterm infants were randomly assigned to intervention (n=20) and control (n=20) groups using stratified randomization. Study data were collected using "Infant Information Form", "Physiological Parameter Follow-up Form" and "Nutrition Follow-up Form" developed by the researchers. Intranasal breast milk was administered to infants in the intervention group before three consecutive feedings per day (09.00, 12.00 and 15.00) for three days. In the intervention group, 0.1 ml of breast milk was administered intranasally into the right nostril and 0.1 ml into the left nostril. The control group continued to receive routine clinical care. During each intervention period, physiological parameters (cerebral oxygenation, oxygen saturation, heart rate, and respiratory rate) were recorded at baseline (T0), 5 minutes after the intervention (T1), 15 minutes after the intervention (T2), and 30 minutes after the intervention (T3). The time required for preterm infants to achieve full oral feeding was monitored until discharge. Vomiting and defecation frequency were observed daily for three consecutive days. The study was registered at ClinicalTrials.gov (NCT06706115). As a result of the study, it was determined that cerebral rSO₂ levels of preterm infants who received intranasal breast milk were significantly higher than the control group (F=64.894; p<0.001; η2=0.631) and respiratory rate (F=8.544; p<0.001; η2=0.184) was lower at some measurement times. On the other hand, no significant difference was found between the groups in terms of oxygen saturation (p>0,005), heart rate (p>0,005), time to transition to full oral feeding (p>0,005), discharge time (p>0,005), vomiting frequency (p>0,005) and defecation frequency (p>0,005). The findings of this study indicate that intranasal breast milk administration has the potential to increase cerebral rSO₂ in preterm infants. The decrease in respiratory rate within normal limits during administration, the maintenance of oxygen saturation and heart rate, and the infants' tolerance of the procedure suggest that intranasal breast milk administration may be a reliable approach in terms of physiological stability. However, studies investigating the long-term effects of intranasal breast milk administration at different administration frequencies and durations are needed to more clearly demonstrate the safety and efficacy profile of intranasal breast milk administration.