Status:
ACTIVE_NOT_RECRUITING
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
Lead Sponsor:
University of California, Davis
Conditions:
Lactation Disorder With Baby Delivered
Nutrition Disorder, Infant
Eligibility:
FEMALE
18-100 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU)...
Detailed Description
The goal of this clinical trial is to learn about the impact of Kangaroo Care (holding your baby skin-to-skin on your chest) in lactating parents with babies in the Neonatal Intensive Care Unit (NICU)...
Eligibility Criteria
Inclusion
- Lactating Parent/Infant Dyads:
- Lactating parents of infants who are currently admitted to the UCDMC NICU and are expected to remain in the NICU for at least 2 weeks from study enrollment
- Lactating parent is 18 years of age or older
- Infant with prematurity or other conditions prohibiting nutritive feeding at the breast during the study period
- Lactating parent plans to feed their infants breast milk for at least 1 month
- Lactating parent is willing to refrain from tandem feeding another child during the study period
- Willing to refrain from enrolling infant in an interventional research study that may impact growth or feeding tolerance during the study period
- Lactating parent is willing to use a hospital grade pump available in the NICU to express milk for sample collection
- Lactating Parent that is willing to travel to UCDMC on 4 occasions within a 10 day period for study visits
- Providers/staff:
- 1\. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study.
Exclusion
- Infant less than 1 week of age at enrollment
- Lactating parents expressing breast milk for more than one infant
- Lactating parents who are currently or plan to tandem feed another child during the study period
- Lactating parents that are participating in an interventional research study that could influence breast milk production.
- Lactating parents with infants deemed by primary investigator/primary care team to be too unstable for kangaroo care
- Lactating parents that are unwilling to participate in kangaroo care
- Dyads that have participated in nutritive feeding at the breast
- Lactating parents that use recreational drugs that contraindicate breastfeeding/provision of breast milk
- Lactating parents taking therapies, supplements, or medications that are incompatible with breastfeeding/provision of breast milk to their infant
- Lactating parents using, or planning to use, any over-the-counter or prescription medication for the purpose of increasing milk supply (including domperidone, fenugreek, turmeric, blessed milk thistle, Brewer's yeast, or lactation cookies)
- Lactating parents that are involuntarily confined
- Lactating parents that are adults unable to consent
- Lactating parents unwilling to travel to UC Davis NICU for study visits
- Anyone deemed unfit for participation by the investigator(s)
Key Trial Info
Start Date :
November 15 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06047470
Start Date
November 15 2023
End Date
January 1 2026
Last Update
November 19 2025
Active Locations (1)
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1
UC Davis
Sacramento, California, United States, 95817