Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| Pending | Registry Identifier | ICTR award | |
| Protocol Version 5/7/26 | Other Identifier | UW Madison | |
| NUR/FACULTY AFFAIRS/ADMIN | Other Identifier | UW Madison |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will develop a protocol for remote human milk collection for use in gene expression research through application of ribonucleic acid (RNA) preservation reagents. The investigators hypothesize that addition of preservation reagents will preserve RNA in human milk, facilitating downstream analyses that require intact RNA. 50 lactating participants will be recruited and requested to provide reagent-mixed samples to be sent to the university through shipping services where they will be evaluated for RNA quantity, quality and profile.
To preserve the quality of RNAs, commonly used methods for collecting fresh human milk samples typically require a stringent collection and handling routine. This includes proximity to a laboratory (within 20 minutes of driving distance) and ultra-cold storage conditions (below -80°C). Compared to "non-research" settings, current standards in sample collection require either 1) participant travel or 2) home visits for biospecimen collection. These requirements impede the inclusion of wide, non- biased milk samples from a range of populations, which is necessary for robust human subject studies. Subsequently, certain populations are excluded due to arbitrary factors like location, daytime availability, and residence. The development of human milk collection protocols that enable wide-ranging participation is a research priority that supports our research at the University of Wisconsin - Madison and any global investigative efforts that include human milk RNA sequencing.
Recruitment will take place in 2 phases (N=25 participants each) to allow for adjustments to the biospecimen collection kit and optimization of RNA integrity. During the first recruitment phase, N=25 participants will be recruited and enrolled using a reagent: human milk concentration of approximately 2:1. Total volume of human milk collection will not exceed 30 mL.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactating Participants | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remote Human Milk Sample Collection | Device | Two products will be evaluated for their ability to preserve RNA in human milk samples.
|
| Measure | Description | Time Frame |
|---|---|---|
| Successful Development of a Remote Collection Protocol reported as the final Reagent:Sample ratio | The primary endpoint is generation of a remote collection protocol for use with a leading reagent in RNA preservation of human milk. There is no statistical test or null hypothesis associated with this endpoint, rather, a summary of relevant findings from all study secondary and exploratory endpoints. | through study completion, anticipated to be 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Concentration of RNA in Human Milk | The concentration of extracted RNA (ng/uL) will be measured by a Qubit Fluorometer. | through study completion, anticipated to be 1 year |
| Purity of RNA in Human Milk |
| Measure | Description | Time Frame |
|---|---|---|
| Perceived Stress Scale | scored from 0-40 with higher scores indicating higher stress | data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection) |
| Generalized Anxiety Disorder (GAD-7) |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katelyn Desorcy-Scherer, PhD, RN | UW School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53705 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
The purity of extracted RNA will be measured by a Qubit Fluorometer. Purity will be assessed using wavelengths, the ratio of absorbance for A260/280 and A230/280.
| through study completion, anticipated to be 1 year |
| RNA Integrity Number (RIN) | Integrity of the extracted RNA will be measured using an agilent bioanalyzer. RIN is reported on a scale of 1 to 10 where higher numbers indicate higher integrity. | through study completion, anticipated to be 1 year |
| Quantitative PCR (qPCR) | The epithelial cell and microRNA population will be quantified by measuring expression of epithelial cell and microRNA target genes. | through study completion, anticipated to be 1 year |
| Sample Collection Feasibility Data | Participants answer 8-items scored on a 1 (discourage) to 10 (encourage) scale regarding participation in lactation research to assess factors that would facilitate their participation (use of own breast pump, ability to use breast pump, opportunity to privately express a sample in a clinic or at home, handling reagents with gloves, opportunity to participate in maternal and infant health research, opportunity to participate in genetic research). | data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection) |
Scores range from 0 to 21, with higher scores indicating greater anxiety. |
| data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection) |
| Edinburgh Postpartum Depression Scale (EPDS) | scored from 0-30 with higher scores indicating higher depression | data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection) |
| MEDQ-Sus Questionnaire | scored from 0-16 with higher scores indicating greater adherence to a Mediterranean dietary pattern | data collected at time of sample return from participant (one time point greater than one month after lactation begins and within 7 days of sample collection) |