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 range
18 Years – 100 Years
Sex
FEMALE
See this in plain English?
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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