Effect of Intranasal Breast Milk Administration in Preterm Infants

NCT06706115 | Recruiting

• 1 other identifier: SelcukUni2545
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Newborn; Vitality; Nursing Caries; Breast Feeding

Keywords

Breast milk; Newborn Nursing; Oral Nutrition; Physiological parameters; Preterm infant

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (17)

• Physiologic Parameter Follow-up Form -Cerebral rSO2

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

• Physiologic Parameter Follow-up Form -Cerebral rSO2

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

• Physiologic Parameter Follow-up Form -Cerebral rSO2

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

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

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

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

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

Study Arms (2)

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.

Other: Intranasal human breast milk

Control Group

NO INTERVENTION

Preterm newborns in the control group will not receive any intervention.

Interventions

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).

Intranasal Breast Milk Group

Eligibility Criteria

• Age: 28 Weeks - 37 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Selcuk University: lead

Study Sites (1)

Selcuk University

Konya, Turkey (Türkiye)

RECRUITING

Related Publications (5)

• 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.

  PMID: 30386923 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.

  PMID: 38688998 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.

  PMID: 33503882 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.

  PMID: 37682253 BACKGROUND

• 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.

  PMID: 41542903 DERIVED

MeSH Terms

Conditions

Breast Feeding; Premature Birth

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Sibel Kucukoglu, Prof

  Selcuk University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sibel Kucukoglu, Prof

CONTACT

+903322230789; s_nadaroglu@hotmail.com

Adalet Yücel, Assistant

CONTACT

+903322230770; adalet.yucel0@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Randomized controlled design

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: November 26, 2024
• Study Start: June 30, 2024
• Primary Completion: September 15, 2025
• Study Completion: December 30, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)