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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
Tar emot friska volontärer
Beskrivning
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
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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.
|
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.
|
|
Aktiv komparator: 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Gut microbiota composition in preterm infants
Tidsram: 1 year
|
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.
|
1 year
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time to full enteral feeding
Tidsram: 1 year
|
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.
|
1 year
|
|
Feeding intolerance
Tidsram: 1 year
|
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).
|
1 year
|
|
Necrotizing enterocolitis
Tidsram: 1 year
|
Necrotizing enterocolitis will be diagnosed according to modified Bell's criteria stage II or higher.
|
1 year
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Urogenitala sjukdomar
- Kvinnliga urogenitala sjukdomar och graviditetskomplikationer
- Tarmsjukdomar
- Obstetrisk förlossning, för tidigt
- Obstetriska förlossningskomplikationer
- Graviditetskomplikationer
- Matsmältningssystemets sjukdomar
- Gastrointestinala sjukdomar
- Gastroenterit
- Enterokolit
- För tidig födsel
- Enterokolit, nekrotiserande
Andra studie-ID-nummer
- PREMIC-2026
Läkemedels- och apparatinformation, studiedokument
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