Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intranasal Breast Milk Group | Experimental | 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. |
|
| Control Group | No Intervention | Preterm newborns in the control group will not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intranasal human breast milk | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physiologic Parameter Follow-up Form -Cerebral rSO2 | Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention. | Second measurement- 5. minutes after the intervention (T1) |
| Physiologic Parameter Follow-up Form -Cerebral rSO2 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sibel Kucukoglu, Prof | Contact | +903322230789 | 31623 | s_nadaroglu@hotmail.com |
| Adalet Yücel, Assistant | Contact | +903322230770 | adalet.yucel0@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Sibel Kucukoglu, Prof | Selcuk University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Selcuk University | Recruiting | Konya | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30386923 | Background | Keller T, Korber F, Oberthuer A, Schafmeyer L, Mehler K, Kuhr K, Kribs A. Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation. Eur J Pediatr. 2019 Feb;178(2):199-206. doi: 10.1007/s00431-018-3279-7. Epub 2018 Nov 1. | |
| 38688998 | Background | Hoban R, Gallipoli A, Signorile M, Mander P, Gauthier-Fisher A, Librach C, Wilson D, Unger S. Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage. J Perinatol. 2024 Nov;44(11):1652-1657. doi: 10.1038/s41372-024-01982-8. Epub 2024 Apr 30. |
Not provided
Not provided
It will be shared after the article is published.
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
Not provided
Not provided
Randomized controlled design
Not provided
Not provided
Not provided
|
| First measurement- intranasal breast milk content |
Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention. |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | Second measurement- Discharge time |
| 33503882 | Background | Muelbert M, Alexander T, Pook C, Jiang Y, Harding JE, Bloomfield FH. Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study. Nutrients. 2021 Jan 25;13(2):350. doi: 10.3390/nu13020350. |
| 37682253 | Background | Yucel A, Kucukoglu S, Soylu H. The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial. Biol Res Nurs. 2024 Jan;26(1):160-175. doi: 10.1177/10998004231200784. Epub 2023 Sep 8. |
| 41986747 | Derived | Yucel A, Kucukoglu S, Konak M. Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study. Eur J Pediatr. 2026 Apr 16;185(5):272. doi: 10.1007/s00431-026-06922-6. |
| 41542903 | Derived | Yucel A, Kucukoglu S, Konak M. The Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Time to Full Oral Feeding in Preterm Infants: a Randomised Controlled Study Protocol. Nurs Crit Care. 2026 Jan;31(1):e70262. doi: 10.1111/nicc.70262. |
| D011248 |
| Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |