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
연구 개요
상태
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: 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.
|
|
활성 비교기: 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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gut microbiota composition in preterm infants
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Time to full enteral feeding
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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