Intranasal breast milk for premature infants with severe intraventricular hemorrhage-an observation.
Titus Keller, Friederike Körber, André Oberthuer...
https://pubmed.ncbi.nlm.nih.gov/30386923Actively Recruiting
Phase Not Applicable
Age: 28Weeks - 37Weeks
All Genders
Healthy Volunteers
ID06706115
Effect of Intranasal Breast Milk Administration on Cerebral Oxygenation, Vital Signs and Transition Time to Full Oral Feeding in Preterm Babies: Randomized Controlled Study
Led by Selcuk University · Updated on 2024-11-26
40
Participants Needed
1
Research Sites
15 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effect of giving breast milk through the nose on brain oxygen levels, vital signs, and the time it takes for preterm infants to start full oral feeding. The study focuses on preterm babies born between 28 and 37 weeks of gestation. Breast milk contains special stem cells that may reach the brain through the nasal passages and help protect against brain damage in newborns. Previous research suggests this method could be tolerated well by preterm infants and might reduce brain injury after bleeding in the brain. In this randomized study, preterm infants in the intervention group will receive 0.2 ml of breast milk administered intranasally three times a day for three days. Breast milk is given by dripping 0.1 ml into each nostril while the baby lies on their back. The control group will not receive any intervention. After the breast milk administration, babies will be fed as usual by the neonatal nurse. This process is repeated at set times (9:00 AM, 12:00 PM, and 3:00 PM) over the three-day period. During the study, researchers will monitor brain oxygen levels, oxygen saturation, heart rate, and breathing rate before and at intervals after the breast milk administration. They will also track feeding details, vomiting, bowel movements, time to full oral feeding, and discharge timing. Data are collected on the first day of hospitalization and throughout the intervention days to assess the effects. The study lasts for the three-day intervention period, with careful observation and recording of vital signs and feeding progress.
CONDITIONS
Brief Title
Effect of Intranasal Breast Milk Administration in Preterm Infants
Who Can Participate
Age: 28Weeks - 37Weeks
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Birth weight greater than 1000 grams
- APGAR score greater than 7 at 5 minutes after birth
- Availability of breast milk
- No medical diagnosis affecting cerebral oxygenation such as intraventricular hemorrhage, cardiovascular or neurological disorders, anemia
- No congenital anomalies or chromosomal abnormalities
- No congenital anomaly affecting nasal patency, such as cleft palate
You will not qualify if you...
- 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 or alcohol abuse, HIV infection, untreated active tuberculosis, chemotherapy or radiotherapy treatment
- Mother has mastitis, breast trauma, abscesses, or is taking any medication that passes into the milk
- Mother does not want to express milk
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 days
Participants in the intervention group receive 0.2 ml of breast milk intranasally three times a day for three days. Participants in the control group do not receive any intervention. Physiologic parameters and feeding outcomes are monitored closely around each administration.
3 visits per day (in-person) for 3 days
Trial Site Locations
Total: 1 location
1
Selcuk University
Konya, Turkey (Türkiye)
Actively Recruiting
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Research Team
S
Sibel Kucukoglu, Prof
A
Adalet Yücel, Assistant
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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Published Research Related To This Trial
Feasibility of intranasal human milk as stem cell therapy in preterm infants with intraventricular hemorrhage.
Rebecca Hoban, Alessia Gallipoli, Marisa Signorile...
https://pubmed.ncbi.nlm.nih.gov/38688998Cortical Oxygenation Changes during Gastric Tube Feeding in Moderate- and Late-Preterm Babies: A NIRS Study.
Mariana Muelbert, Tanith Alexander, Chris Pook...
https://pubmed.ncbi.nlm.nih.gov/33503882The Effect of Breast Milk Odor on Feeding Cues, Transition Time to Oral Feeding, and Abdominal Perfusion in Premature Newborns: A Randomised Controlled Trial.
Adalet Yücel, Sibel Küçükoğlu, Hanifi Soylu
https://pubmed.ncbi.nlm.nih.gov/37682253Effect of intranasal breast milk administration on cerebral oxygenation, vital signs, and transition time to full oral feeding in preterm infants: a randomized controlled study.
Adalet Yücel, Sibel Küçükoğlu, Murat Konak
https://pubmed.ncbi.nlm.nih.gov/41986747The 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.
Adalet Yücel, Sibel Küçükoğlu, Murat Konak
https://pubmed.ncbi.nlm.nih.gov/41542903