Effect of Intranasal Breast Milk Administration in Preterm Infants

Selcuk University40 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Newborn; Vitality Nursing Caries Breast Feeding

Interventions

Intranasal human breast milkOTHER

The information in the "Physiologic Parameter Follow-up Form" will be recorded by the investigator just 5 minutes before the intervention. The researcher will drip 0.2 ml of breast milk at room temperature (approximately 22 °C) into the nose of the infant lying in the supine position, 0.1 ml in the right nose-0.1 ml in the left nose. 5 minutes after the intervention (T1), 15 minutes after the intervention (T2) and 30 minutes after the intervention (T3), the data in the "Physiologic Parameter Follow-up Form" will be recorded by the researcher. After intranasal breast milk administration, the baby will be fed by the neonatal nurse as in routine practice. The implementation of the intervention in the study will last for three days and this process will be repeated three times every day (09.00, 12.00 and 15.00).

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 37 WeeksHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

Outcomes

Primary Outcomes

Infant Information Form

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)

Time frame: First measurement-First day of hospitalization

Physiologic Parameter Follow-up Form-Cerebral rSO2

Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

Time frame: First measurement- 5 minutes before the intervention (T0)

Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)

Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

Time frame: First measurement- 5 minutes before the intervention (T0)

Physiologic Parameter Follow-up Form-Heart Rate (HR)

Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

Time frame: First measurement- 5 minutes before the intervention (T0)

Physiologic Parameter Follow-up Form-Respiratory rate

Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

Time frame: First measurement- 5 minutes before the intervention (T0)

Nutrition Follow-up Form-intranasal breast milk content

Intranasal breast milk content (fresh/thawed) in the Nutrition Follow-up Form will be recorded before the intervention.

Time frame: First measurement- intranasal breast milk content

Secondary Outcomes

Central Contacts

Sibel Kucukoglu, Prof

CONTACT

+903322230789 s_nadaroglu@hotmail.com

Adalet Yücel, Assistant

CONTACT

+903322230770 adalet.yucel0@gmail.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Physiologic Parameter Follow-up Form -Cerebral rSO2

Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

Time frame: Second measurement- 5. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Cerebral rSO2

Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

Time frame: Second measurement- 15. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Cerebral rSO2

Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

Time frame: Second measurement- 30. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

Time frame: Second measurement- 5. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

Time frame: Second measurement- 15. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)

Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

Time frame: Second measurement- 30. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Heart Rate (HR)

Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

Time frame: Second measurement- 5. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Heart Rate (HR)

Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

Time frame: Second measurement- 15. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Heart Rate (HR)

Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

Time frame: Second measurement- 30. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Respiratory rate

Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

Time frame: Second measurement- 5. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Respiratory rate

Respiratory rate in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

Time frame: Second measurement- 15. minutes after the intervention (T1)

Physiologic Parameter Follow-up Form -Respiratory rate

Respiratory rate in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

Time frame: Second measurement- 30. minutes after the intervention (T1)

Nutrition Follow-up Form-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.

Time frame: Second measurement-Nutrient content

Nutrition Follow-up Form-Number of vomits

Number of vomits in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

Time frame: Second measurement- Number of vomits

Nutrition Follow-up Form-Number of defecations

Number of defecations in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

Time frame: Second measurement- Number of defecations

Nutrition Follow-up Form-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.

Time frame: Second measurement- The time of transition to full oral feeding

Nutrition Follow-up Form-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.

Time frame: Second measurement- Discharge time