Breast Feeding, Human Microbiome
Conditions
Brief summary
This study will explore the effects of skin-to-skin contact (SSC) between mothers and their babies on the infant intestinal microbiome, the maternal skin microbiome and the breast milk microbiome. This will be accomplished by administering an intervention education session to one group and a placebo education session to the second group in order to influence the magnitude of total SSC defined by the frequency and duration of contact time between the two groups.
Interventions
OTHERIntervention education
An education package that includes an enhanced emphasis on maternal-infant skin-to-skin contact and a detailed activity log for recording early post-partum care practices that includes specific skin-to-skin contact time and frequency goals.
OTHERPlacebo Education
An education package that includes a basic emphasis on maternal-infant skin-to-skin contact, as well as other general post-partum care practices and a general early post-partum care practices log without specific skin-to-skin contact goals.
Sponsors
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women scheduled to deliver at the University of Virginia Health System * Women 18 years or older and their newborn infant * Stated intent to exclusively breastfeed for the duration of post-partum hospital admission * To have physical custody of their child when they are discharged from the hospital
Exclusion criteria
* Maternal antibiotic use in the 3 months prior to delivery * Consumption of alcohol in the 3 months prior to delivery * Recreational drug use in the 3 months prior to delivery * Serious gastrointestinal conditions requiring medical intervention or medication during pregnancy (e.g. Crohn's disease, ulcerative colitis, celiac disease, gastrointestinal infections) * Serious health conditions that require medication during pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Skin-to-skin contact | Duration of hospital admission after delivery (2-3 days) | Self-reported magnitude of maternal-infant skin-to-skin contact |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maternal skin microbiome | Duration of hospital admission after delivery (2-3 days) | Maternal breast area skin microbiome |
| Maternal breast milk microbiome | Duration of hospital admission after delivery (2-3 days) | Maternal first and early milk microbiome |
| Infant intestinal microbiome | Duration of hospital admission after delivery (2-3 days) | Infant fecal microbiome |
| Maternal dietary intake | During pregnancy | Maternal dietary intake of probiotic or culture-enhanced foods |
Countries
United States
Outcome results
None listed