Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care (NCT06047470) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
United States25 participantsStarted 2023-11-15
Plain-language 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) that cannot directly breastfeed.
Who can participate
Age range18 Years – 100 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
Exclusion criteria
✕. 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.
What they're measuring
1
Breast milk calories (kcal/dL) by kangaroo care intervention
Timeframe: 10 days
2
Breast milk fat (g/dL) by kangaroo care intervention
Timeframe: 10 days
3
Breast milk protein (g/dL) by kangaroo care intervention
Timeframe: 10 days
4
Breast milk carbohydrate (g/dL) by kangaroo care intervention
Timeframe: 10 days
5
Breast milk volume in mL by kangaroo care intervention
Timeframe: 10 days
6
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time
Timeframe: 10 days
7
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC incomplete
Timeframe: 10 days
8
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Parental attitudes