Effect of Rectal Administration of Breast Milk on Gut Microbiota in Preterm Infants (premic)
Effect of Rectal Administration of Human Milk on Gut Microbiota and Clinical Outcomes in Preterm Infants: A Randomized Controlled Study
Přehled studie
Postavení
Detailní popis
Preterm infants are highly vulnerable to alterations in gut microbiota due to immaturity, delayed enteral feeding, antibiotic exposure, and environmental factors. Early-life dysbiosis has been associated with adverse outcomes including necrotizing enterocolitis, sepsis, and impaired immune development. Strategies to promote healthy microbiota colonization in preterm infants are therefore of significant clinical interest.
Breast milk contains beneficial bacteria, prebiotics, and bioactive components that play a critical role in shaping neonatal gut microbiota. However, in the early postnatal period, especially in very preterm infants, enteral feeding may be limited or delayed. Alternative routes of exposure to breast milk components may offer a potential strategy to influence microbiota development.
This randomized controlled study aims to investigate the effects of rectal administration of maternal breast milk on gut microbiota in preterm infants. Participants will be randomly assigned to receive either rectal maternal breast milk or normal saline. Stool samples will be collected at predefined time points to assess microbiota composition.
The study is designed to explore whether rectal exposure to breast milk can modulate early microbial colonization and provide a feasible, safe, and innovative approach to support gut microbiota development in preterm infants.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Preterm infants with a gestational age ≤32 weeks and birth weight ≤1500 g
Infants without meconium passage within the first 48 hours of life
Infants whose parents have provided written informed consent
Exclusion Criteria:
nfants with major congenital anomalies
Infants with gastrointestinal system anomalies
Infants in whom administration of maternal breast milk is contraindicated
Infants whose parents do not provide consent for participation
Infants who die within the first 72 hours of life
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Singl
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Experimentální: Rectal irrigation with maternal breast milk
Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00.
A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used.
The enema volume will be calculated as 5 mL/kg and warmed to 37°C.
One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication.
The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.
Maternal breast milk will be used for rectal irrigation.
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Maternal breast milk will be used for rectal irrigation .
Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00.
A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used.
The enema volume will be calculated as 5 mL/kg and warmed to 37°C.
One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication.
The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.
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Aktivní komparátor: Rectal irrigation with normal saline
Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00.
A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used.
The enema volume will be calculated as 5 mL/kg and warmed to 37°C.
One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication.
The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.Normal saline will be used for rectal irrigation as an active comparator.
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Rectal irrigation will be performed starting 48 hours after birth, twice daily for 5 consecutive days at 09:00 and 21:00.
A 6 Fr feeding tube, 5 mL syringe, thermostatically controlled water bath (set at 37°C), sterile water-based lubricant, and sterile gloves will be used.
The enema volume will be calculated as 5 mL/kg and warmed to 37°C.
One end of the feeding tube will be connected to the syringe, and the other end will be gently inserted into the rectum after lubrication.
The solution will be administered slowly over approximately 3 minutes, and the tube will then be carefully removed.
Normal saline will be used for rectal irrigation as an active comparator.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Gut microbiota composition in preterm infants
Časové okno: 1 year
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Gut microbiota composition will be analyzed using stool samples collected from preterm infants at 7 days and 1 month of life, including assessment of microbial diversity and relative abundance of bacterial taxa, to evaluate differences between study groups.
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1 year
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Time to full enteral feeding
Časové okno: 1 year
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Time to achieve full enteral feeding will be defined as the number of days from birth until the infant tolerates full enteral nutrition without the need for parenteral nutrition.
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1 year
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Feeding intolerance
Časové okno: 1 year
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Feeding intolerance will be defined as the occurrence of bilious emesis, gastric residuals, visibly bloody stools, abdominal distension or tenderness, abdominal discoloration, gastric residual volume exceeding 50% of the previous feeding volume, emesis occurring three or more times within a 24-hour period, or clinical or radiological evidence of necrotizing enterocolitis (NEC).
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1 year
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Necrotizing enterocolitis
Časové okno: 1 year
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Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher.
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1 year
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Urogenitální onemocnění
- Ženské urogenitální onemocnění a těhotenské komplikace
- Střevní nemoci
- Porodnický porod, předčasný
- Porodnické porodní komplikace
- Těhotenské komplikace
- Nemoci trávicího systému
- Gastrointestinální onemocnění
- Gastroenteritida
- Enterokolitida
- Předčasný porod
- Enterokolitida, nekrotizující
Další identifikační čísla studie
- PREMIC-2026
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