RecruitingNot Applicable

Effect of Intranasal Breast Milk Administration in Preterm Infants

Turkey (Türkiye)40 participantsStarted 2024-06-30

Plain-language 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.

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Infant Information Form

Timeframe: First measurement-First day of hospitalization

Physiologic Parameter Follow-up Form-Cerebral rSO2

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

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

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

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

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

Physiologic Parameter Follow-up Form-Respiratory rate

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

Nutrition Follow-up Form-intranasal breast milk content

Timeframe: First measurement- intranasal breast milk content

Trial details

NCT IDNCT06706115

SponsorSelcuk University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-09-15

Contact for this trial

Sibel Kucukoglu, Prof

+903322230789 s_nadaroglu@hotmail.com

View on ClinicalTrials.gov More Newborn; Vitality trials

Who can participate

Age range

28 Weeks – 37 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Infant Information Form

Timeframe: First measurement-First day of hospitalization

Physiologic Parameter Follow-up Form-Cerebral rSO2

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

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

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

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

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

Physiologic Parameter Follow-up Form-Respiratory rate

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

Nutrition Follow-up Form-intranasal breast milk content

Timeframe: First measurement- intranasal breast milk content