Effect of Intranasal Breast Milk Administration in Preterm Infants

Not Applicable

Recruiting

• Conditions: Newborn; Vitality; Nursing Caries; Breast Feeding

• Registration Number: NCT06706115
• Lead Sponsor: Selcuk University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-05-21
• Study Start: 2024-06-30
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-09-15
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Infant Information Form	First measurement-First day of hospitalization	The form developed by the researchers in line with the literature includes the identifying information of the preterm infant (gender, date of birth, gestational week at birth, mode of delivery, APGAR score, birth weight, postmenstrual age)
Physiologic Parameter Follow-up Form-Cerebral rSO2	First measurement- 5 minutes before the intervention (T0)	Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)	First measurement- 5 minutes before the intervention (T0)	Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Heart Rate (HR)	First measurement- 5 minutes before the intervention (T0)	Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Physiologic Parameter Follow-up Form-Respiratory rate	First measurement- 5 minutes before the intervention (T0)	Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.
Nutrition Follow-up Form-intranasal breast milk content	First measurement- intranasal breast milk content	Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.

Secondary Outcome Measures

Name	Time	Method
Physiologic Parameter Follow-up Form -Cerebral rSO2	Second measurement- 30. minutes after the intervention (T1)	Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)	Second measurement- 30. minutes after the intervention (T1)	Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Physiologic Parameter Follow-up Form -Heart Rate (HR)	Second measurement- 30. minutes after the intervention (T1)	Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Physiologic Parameter Follow-up Form -Respiratory rate	Second measurement- 30. minutes after the intervention (T1)	Respiratory rate in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.
Nutrition Follow-up Form-Nutrient content	Second measurement-Nutrient content	Nutrient content (exclusive breast milk/formula+ breast milk feeding) in the Nutrition Follow-up Form will be recorded 5 minutes after the intervention.
Nutrition Follow-up Form-Number of vomits	Second measurement- Number of vomits	Number of vomits in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.
Nutrition Follow-up Form-Number of defecations	Second measurement- Number of defecations	Number of defecations in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.
Nutrition Follow-up Form-The time of transition to full oral feeding	Second measurement- The time of transition to full oral feeding	The time of transition to full oral feeding, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.
Nutrition Follow-up Form-Discharge time	Second measurement- Discharge time	Discharge time, which is found on the Feeding Follow-up Form, will be monitored and recorded in medical records until the baby is discharged.

Trial Locations

Locations (1)

Selcuk University; 🇹🇷 Konya, Turkey