Effect of Intranasal Breast Milk Administration in Preterm Infants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-30

Study Completion Date

2025-12-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Oropharyngeal Colostrum Administration in Premature Infants

NCT06631703

Oral Colostrum Administration Early Feeding Skills Transition to Oral Feeding

COMPLETED NA

Feasibility and Safety of Intranasally Administered Breast Milk in HIE

NCT06747260

Hypoxic Ischaemic Encephalopathy (HIE) Hypoxic Ischemic Encephalopathy of Newborn Neonatal Encephalopathy +4 more

RECRUITING EARLY_PHASE1

The Effect of Breast Milk Smell on Nutrition in Preterms

NCT04843293

Breast Milk Digestion Nutrition +2 more

UNKNOWN NA

The Effect of Breast Milk Odor on Feeeding in Preterm Infants

NCT06563973

Bottle Feeding Preterm İnfant

COMPLETED NA

The Effect Of Breast Milk Sniffing And Tasting On Early Feeding Tips

NCT06341153

Breastfeeding Odors, Body Newborn; Vitality

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Newborn; Vitality Nursing Caries Breast Feeding

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled design

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Intranasal human breast milk

Intervention Type 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).

Control Group

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

28 Weeks

Maximum Eligible Age

37 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes