Milk in Life Conditions (MiLC): Bacterial Composition of Human Milk Pumped and Stored in "Real-Life" Conditions (MiLC)
Milk in Life Conditions (MiLC): Characterizing the Bacterial Composition of Human Milk Pumped and Stored in "Real-life" Conditions
연구 개요
상세 설명
Participants will donate 1 oz of human milk during each of two consecutive pumping sessions, for a total volume of 2 oz donated on one day. To collect this human milk, participants will be asked to fully express one breast during each pumping session. Participants will pump once with the participant's own pump set-up and once with the sterile pump set-up (provided by the research team). Women will be randomized to which pump is used first.
Randomization will be done using stratified randomization as follows: participants were stratified by how their infants were fed, namely whether infants were fed human milk only vs. human milk and complementary foods). Then, randomization was conducted within each strata. The researchers aim to have a minimum of 25 participants in each stratum.
All human milk collections will occur at participants' homes between 0700 and 1100 hours. The second pumping session must begin 3 hours (+/-30 minutes) after the beginning of the first pumping session (e.g. the first pumping session at 7:30 am and the second at 10:30 am). Participants will elect from which breast to donate human milk and that breast will be used for both pumping sessions. Participants will be asked not to nurse from or pump that breast during the 2 hours before the first pumping session and not until after the second pumping session (a total of ~5.5 hours).
From the milk produced during each pumping session (which could be up to ~6 oz), researchers will collect 1 oz using a sterile, plastic syringe. Participants will keep the remaining volume of milk. Each ounce of milk collected will be separated into 5 sterile containers (provided). Participants will store donated milk at home until it is picked up by a researcher 2, 4, and 30 days after pumping.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New York
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Ithaca, New York, 미국, 14853
- Hay Laboratory, B75C Wing Hall, Cornell University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Lactating women over the age of 18 years
- Self-reported as healthy women and infants
- Use an electric breast pump
- Confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions where pumping sessions are 3 hours (+/- 30 minutes) apart and between 0700-1100 hours.
- Able to store donated milk at home for 30 days
- Have infants who do not consume formula or only consume formula episodically as long as the most recent formula-feeding occurred > 2 weeks before the day milk is pumped for this study.
Exclusion Criteria:
- Not confident of ability to donate 1 oz of milk from one breast during each of two consecutive pumping sessions, 3 hours (+/- 30 minutes) apart and between the hours of 0700-1100 hours.
- Infant consumption of formula in the past 2 weeks
- Current indication of breast infection (e.g., breast pain, discomfort, lumps, mastitis with fever, red streaks, or hard red portions of the breast)
- Breast pain that the woman does not consider "normal" for lactation/breastfeeding
- Signs/symptoms of acute illness in woman or infant in past 7 days including fever (rectal or temporal temperature ≥99.5 F), dark green nasal discharge, diarrhea (abrupt onset of 3 or more excessively "loose" stools in one day), vomiting (where infant vomiting is not associated with feeding), or severe cough.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 크로스오버 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Sterile pump set-up first
Participants will pump with sterile pump set-ups first.
Approximately 3 hours later, participants will pump with their own pump set-ups.
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Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
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실험적: Mother's Own pump set-up first
Participants will pump with their own pump set-ups first.
Approximately 3 hours later, participants will pump with sterile pump set-ups.
|
Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S).
Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices).
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bacterial Community Richness
기간: 0 days after pumping
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Richness is the total number of different bacterial taxa detected in the sample.
This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
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0 days after pumping
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Bacterial Community Diversity
기간: 0 days after pumping
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Bacterial community diversity will be assessed using the the Shannon diversity index.
The Shannon diversity index is a type of entropy measure and is a function of the distribution of the total number of organisms across all of the species.
If S is the total number of species in the sample and p_i is the number of organisms in the i-th species divided by the total number of organisms, then Diversity = -Σ p_i log(p_i).
This metric will be assessed on data collected via high-throughput sequencing of the bacterial 16S rRNA gene present in milk.
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0 days after pumping
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Total Live Aerobic Bacterial Counts
기간: 0 days after pumping
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Number of live total aerobic bacteria in milk assessed by aerobic culturing of milk on plate count agar.
Reported as colony-forming units (CFU)/mL.
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0 days after pumping
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공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Kathleen M. Rasmussen, ScD, Cornell University
- 수석 연구원: Anthony Hay, PhD, Cornell University
- 연구 책임자: Sarah Reyes, MS, Cornell University
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB #: 1608006566
- 2T32DK007158-42 (미국 NIH 보조금/계약)
- NYC-399436 (기타 보조금/기금 번호: NIFA/USDA)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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