Breast Feeding, Newborn; Vitality, Nursing Caries
Conditions
Keywords
Breast milk, Newborn Nursing, Oral Nutrition, Physiological parameters, Preterm infant
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.
Interventions
OTHERIntranasal human breast milk
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).
Sponsors
Selcuk University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
Randomized controlled design
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 37 Weeks
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Physiologic Parameter Follow-up Form -Cerebral rSO2 | Second measurement- 5. minutes after the intervention (T1) | Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention. |
| 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. |
| 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. |
| Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2) | Second measurement- 5. minutes after the intervention (T1) | Oxygen saturation (sPO2) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention. |
| Physiologic Parameter Follow-up Form -Heart Rate (HR) | Second measurement- 5. minutes after the intervention (T1) | Heart Rate (HR) in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention. |
| Physiologic Parameter Follow-up Form -Respiratory rate | Second measurement- 5. minutes after the intervention (T1) | Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 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. |
Countries
Turkey (Türkiye)
Contacts
Primary ContactSibel Kucukoglu, Prof
Backup ContactAdalet Yücel, Assistant
Outcome results
None listed