Clinical trial NCT06706115: Effect of Intranasal Breast Milk Administration in Preterm Infants
Official title: : Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Newborn; Vitality
Nursing Caries
Breast Feeding
Keywords: Breast milk
Newborn Nursing
Oral Nutrition
Physiological parameters
Preterm infant
Lead sponsor: Selcuk University
Sponsor class: OTHER
First posted: 2024-11-26
Enrollment: 40
Sex: ALL
Minimum age (years): 28
Maximum age (years): 37
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled design
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Infant Information Form
timeFrame: First measurement-First day of hospitalization
measure: Physiologic Parameter Follow-up Form-Cerebral rSO2
timeFrame: First measurement- 5 minutes before the intervention (T0)
measure: Physiologic Parameter Follow-up Form-Oxygen saturation (sPO2)
timeFrame: First measurement- 5 minutes before the intervention (T0)
measure: Physiologic Parameter Follow-up Form-Heart Rate (HR)
timeFrame: First measurement- 5 minutes before the intervention (T0)
measure: Physiologic Parameter Follow-up Form-Respiratory rate
timeFrame: First measurement- 5 minutes before the intervention (T0)
measure: Nutrition Follow-up Form-intranasal breast milk content
timeFrame: First measurement- intranasal breast milk content
Secondary outcomes:
measure: Physiologic Parameter Follow-up Form -Cerebral rSO2
timeFrame: Second measurement- 5. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Cerebral rSO2
timeFrame: Second measurement- 15. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Cerebral rSO2
timeFrame: Second measurement- 30. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
timeFrame: Second measurement- 5. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
timeFrame: Second measurement- 15. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Oxygen saturation (sPO2)
timeFrame: Second measurement- 30. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Heart Rate (HR)
timeFrame: Second measurement- 5. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Heart Rate (HR)
timeFrame: Second measurement- 15. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Heart Rate (HR)
timeFrame: Second measurement- 30. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Respiratory rate
timeFrame: Second measurement- 5. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Respiratory rate
timeFrame: Second measurement- 15. minutes after the intervention (T1)
measure: Physiologic Parameter Follow-up Form -Respiratory rate
timeFrame: Second measurement- 30. minutes after the intervention (T1)
measure: Nutrition Follow-up Form-Nutrient content
timeFrame: Second measurement-Nutrient content
measure: Nutrition Follow-up Form-Number of vomits
timeFrame: Second measurement- Number of vomits
measure: Nutrition Follow-up Form-Number of defecations
timeFrame: Second measurement- Number of defecations
measure: Nutrition Follow-up Form-The time of transition to full oral feeding
timeFrame: Second measurement- The time of transition to full oral feeding
measure: Nutrition Follow-up Form-Discharge time
timeFrame: Second measurement- Discharge time
Other outcomes:
Locations:
city: Konya
country: Turkey
facility: Selcuk University
Study officials:
affiliation: Selcuk University
name: Sibel Kucukoglu, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.