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| ID | Type | Description | Link |
|---|---|---|---|
| 2T32DK007158-42 | U.S. NIH Grant/Contract | View source | |
| NYC-399436 | Other Grant/Funding Number | NIFA/USDA |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| University of Idaho | OTHER |
| United States Department of Agriculture (USDA) | FED |
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The MiLC trial is a randomized control trial of two different breast pump set-ups: mother's own and sterile. The objective of this trial is to investigate the bacterial composition of human milk pumped and stored in "real-life" conditions. To meet this objective, lactating mothers will fully express breast milk from one breast on two consecutive pumping sessions at home, once with the participant's own pumps and collection kits (own pump set-up) and once with a hospital-grade pump and disposable, sterile collection kits (sterile pump set-up). Randomization will be used to determine which pump participants use first. From the total volume of milk pumped during each pumping session, the researchers will collect 1 oz. Milk from both pumps will be stored at home and sampled on days 0, 2, 4, and 30 after expression for analysis of its bacterial composition.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sterile pump set-up first | Experimental | Participants will pump with sterile pump set-ups first. Approximately 3 hours later, participants will pump with their own pump set-ups. |
|
| Mother's Own pump set-up first | Experimental | Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sterile pump set-up | Device | Medela symphony breast pump (model number 0240108) and disposable, sterile collection kits (model number 67399S). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bacterial Community Richness | 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. | 0 days after pumping |
| Bacterial Community Diversity | 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. | 0 days after pumping |
| Total Live Aerobic Bacterial Counts | 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. | 0 days after pumping |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen M. Rasmussen, ScD | Cornell University | Principal Investigator |
| Anthony Hay, PhD | Cornell University | Principal Investigator |
| Sarah Reyes, MS | Cornell University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hay Laboratory, B75C Wing Hall, Cornell University | Ithaca | New York | 14853 | United States |
The researchers are currently undecided about how all the data from the study will be released but 16S rRNA data will be released through INSDC (the International Nucleotide Sequence Database Collaboration, which encompasses NCBI, EBI and DDBJ).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Mother's Own Pump Set-up First |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bacterial Community Richness | 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. | Data analyzed for all participants | Posted | Mean | Standard Deviation | Observed taxa | 0 days after pumping |
|
No adverse events data collected for this study
No adverse events data collected for this study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sarah Reyes | Cornell University | 208-921-4967 | smr296@cornell.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 2, 2017 | Apr 29, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D061186 | Breast Milk Expression |
| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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All participants will pump their milk with two pump set-ups: own and sterile supplies. The pump set-up each woman used first was randomized according to infant feeding status (human milk only vs. human milk and complementary foods).
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| Mother's Own pump set-up | Device | Mother's own electric breast pump and own collection kit (previously used and cleaned at home using her usual practices). |
|
Participants will pump with their own pump set-ups first. Approximately 3 hours later, participants will pump with sterile pump set-ups.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Infant feeding status, number fed human milk only | Count of Participants | Participants |
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| Primary | Bacterial Community Diversity | 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. | Data analyzed from all participants. | Posted | Mean | Standard Deviation | Shannon Diversity Index | 0 days after pumping |
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| Primary | Total Live Aerobic Bacterial Counts | 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. | Data for all participants analyzed. | Posted | Geometric Mean | Standard Deviation | Colony-forming units (CFU)/mL | 0 days after pumping |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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