Effect of Intranasal Breast Milk Administration in Preterm Infants

: Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Feeding; Nursing Caries; Newborn; Vitality
• Intervention / Treatment: Other: Intranasal human breast milk

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sibel Kucukoglu, Prof; Phone Number: 31623 +903322230789; Email: s_nadaroglu@hotmail.com
• Study Contact Backup: Name: Adalet Yücel, Assistant; Phone Number: +903322230770; Email: adalet.yucel0@gmail.com

Study Locations

• Turkey
  • Konya, Turkey
    • Recruiting
    • Selcuk University
    • Contact: Sibel Küçükoğlu, Prof; Email: s_nadaroglu@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal Breast Milk Group; 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.	Other: Intranasal 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).
No Intervention: Control Group; Preterm newborns in the control group will not receive any intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.	First measurement- intranasal breast milk content

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Selcuk University
• Investigators: Principal Investigator: Sibel Kucukoglu, Prof, Selcuk University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2024
• Primary Completion (Estimated): September 15, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: May 21, 2024
• First Submitted That Met QC Criteria: November 22, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 22, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Preterm infant; Breast milk; Physiological parameters; Oral Nutrition; Newborn Nursing
• Additional Relevant MeSH Terms: Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Premature Birth
• Other Study ID Numbers: SelcukUni2545

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: It will be shared after the article is published.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No