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RecruitingNCT06706115Updated Nov 26, 2024

Effect of Intranasal Breast Milk Administration in Preterm Infants

An interventional study of Intranasal human breast milk in Newborn; Vitality, Nursing Caries and Breast Feeding, sponsored by Selcuk University. Recruiting at 1 site in Turkey (Türkiye). Open to participants aged 28 Weeks to 37 Weeks, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-11-26.

Sponsored by Selcuk University · Not applicable, Interventional, and Supportive care

From the registry’s dates

  • Primary completion was expected by Sep 2025, 1 year 1 month ago, but the record still lists the study as recruiting.
  • Started Jun 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
28 Weeks to 37 Weeks
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Newborn; Vitality
  • Nursing Caries
  • Breast Feeding

Keywords

  • Breast milk
  • Newborn Nursing
  • Oral Nutrition
  • Physiological parameters
  • Preterm infant
03

In context

Breast Feeding

289 studies on the registry are indexed under Breast Feeding; 119 are open to participants now.

This study's planned enrollment of 40 is below the median of 97 across 228 interventional studies indexed under Breast Feeding.

Browse Breast Feeding studies →

Lead sponsor

Selcuk University is the lead sponsor of 255 studies on the registry; 66 are open to participants now.

Browse Selcuk University studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
28 Weeks to 37 Weeks
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (estimated)

Study arms

  • 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

  • No intervention
    Control Group

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

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).

06

What researchers measure

Primary outcomes

  1. 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)

    Time frame: First measurement-First day of hospitalization

  2. Physiologic Parameter Follow-up Form-Cerebral rSO2

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

    Time frame: First measurement- 5 minutes before the intervention (T0)

  3. 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.

    Time frame: First measurement- 5 minutes before the intervention (T0)

  4. Physiologic Parameter Follow-up Form-Heart Rate (HR)

    Heart rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

    Time frame: First measurement- 5 minutes before the intervention (T0)

  5. Physiologic Parameter Follow-up Form-Respiratory rate

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes before the intervention.

    Time frame: First measurement- 5 minutes before the intervention (T0)

  6. 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.

    Time frame: First measurement- intranasal breast milk content

Secondary outcomes

  1. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

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

  2. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

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

  3. Physiologic Parameter Follow-up Form -Cerebral rSO2

    Cerebral rSO2 in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

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

  4. 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.

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

  5. 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.

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

  6. 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.

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

  7. 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.

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

  8. 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.

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

  9. 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.

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

  10. Physiologic Parameter Follow-up Form -Respiratory rate

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 5 minutes after the intervention.

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

  11. Physiologic Parameter Follow-up Form -Respiratory rate

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 15 minutes after the intervention.

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

  12. Physiologic Parameter Follow-up Form -Respiratory rate

    Respiratory rate in the Physiological Parameter Monitoring Form will be measured 30 minutes after the intervention.

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

  13. 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.

    Time frame: Second measurement-Nutrient content

  14. Nutrition Follow-up Form-Number of vomits

    Number of vomits in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

    Time frame: Second measurement- Number of vomits

  15. Nutrition Follow-up Form-Number of defecations

    Number of defecations in the Nutrition Follow-up Form will be recorded 24 hours after the intervention.

    Time frame: Second measurement- Number of defecations

  16. 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.

    Time frame: Second measurement- The time of transition to full oral feeding

  17. 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.

    Time frame: Second measurement- Discharge time

07

Study locations

1 of 1 sites recruiting
08

References and documents

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. PubMed 30386923 ↗
  • 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. PubMed 38688998 ↗
  • 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. PubMed 33503882 ↗
  • 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. PubMed 37682253 ↗
  • 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. PubMed 41986747 ↗
  • 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. PubMed 41542903 ↗

Individual participant data

Plan to share: No — It will be shared after the article is published.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2024 (actual). Primary completion is estimated for Sep 2025, 14 months after the start.

Of 158 non-industry interventional studies with no phase under Breast Feeding, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 25. This study's planned 14 months is above that.

Counting every sponsor, half of 159 studies reached it within 12 months; a quarter within 5 and three quarters within 29.

How these figures are worked out, and which studies are left out of them.

Registered
May 21, 2024
First posted
Nov 26, 2024
StartActual
Jun 30, 2024
Primary completionEst.
Sep 15, 2025
CompletionEst.
Dec 30, 2025
Last update
Nov 26, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 26, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06706115
Lead sponsor
Selcuk University
Responsible party
Sibel Küçükoğlu (Prof, Selcuk University) — Principal investigator
First posted
Nov 26, 2024
Start date
Jun 30, 2024
Primary completion
Sep 15, 2025 (estimated)
Completion
Dec 30, 2025 (estimated)
Last update
Nov 26, 2024

Study contacts

Sibel Kucukoglu, Prof
Contact
s_nadaroglu@hotmail.com
+903322230789 ext. 31623
Adalet Yücel, Assistant
Contact
adalet.yucel0@gmail.com
+903322230770
Sibel Kucukoglu, Prof
principal investigator · Selcuk University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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