Clinical trial NCT06047470: Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
Official title: Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lactation Disorder With Baby Delivered
Nutrition Disorder, Infant
Keywords: Lactation
Kangaroo Care
NICU
Breast milk
Nutrition
Skin to skin
Lead sponsor: University of California, Davis
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study is a mixed methods study comprising of a randomized, crossover interventional trial of Kangaroo Care vs Control and milk expression, study of implementation of scheduled Kangaroo Care in the UC Davis NICU, and qualitative interviews of providers and parents to understand their attitudes and experiences with Kangaroo Care.
Primary purpose: HEALTH_SERVICES_RESEARCH

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) that cannot directly breastfeed.

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) that cannot directly breastfeed.

The main questions it aims to answer are:

* The impact on breast milk volume and macronutrient content (calories, fat, proteins, and carbohydrates)
* Parental experience and perceptions with Kangaroo Care in the University of California (UC) Davis NICU.

Parental participants will:

* Come to the UC Davis NICU for scheduled visits - 4 total visits in a 10 day period.
* Perform Kangaroo Care (holding your baby skin to skin on your chest) for one hour (nurses and other staff will help you place baby comfortably on your chest and be there to help with any questions/concerns while holding)
* Express breast milk per visit schedule (Either before or after Kangaroo Care) using hospital grade pump provided by the NICU
* Provide breast milk sample for analysis (6ml or just over a teaspoon)
* Participate in a brief interview over Zoom (no video required) - this will be about 20 minutes in length

Healthcare provider participants will:

•Participate in a brief interview over Zoom (no video required) - this will be about 20 minutes in length

Eligibility criteria: Inclusion Criteria:

Lactating Parent/Infant Dyads:

1. 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
2. Lactating parent is 18 years of age or older
3. Infant with prematurity or other conditions prohibiting nutritive feeding at the breast during the study period
4. Lactating parent plans to feed their infants breast milk for at least 1 month
5. Lactating parent is willing to refrain from tandem feeding another child during the study period
6. Willing to refrain from enrolling infant in an interventional research study that may impact growth or feeding tolerance during the study period
7. Lactating parent is willing to use a hospital grade pump available in the NICU to express milk for sample collection
8. 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 Criteria:

1. Infant less than 1 week of age at enrollment
2. Lactating parents expressing breast milk for more than one infant
3. Lactating parents who are currently or plan to tandem feed another child during the study period
4. Lactating parents that are participating in an interventional research study that could influence breast milk production.
5. Lactating parents with infants deemed by primary investigator/primary care team to be too unstable for kangaroo care
6. Lactating parents that are unwilling to participate in kangaroo care
7. Dyads that have participated in nutritive feeding at the breast
8. Lactating parents that use recreational drugs that contraindicate breastfeeding/provision of breast milk
9. Lactating parents taking therapies, supplements, or medications that are incompatible with breastfeeding/provision of breast milk to their infant
10. 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)
11. Lactating parents that are involuntarily confined
12. Lactating parents that are adults unable to consent
13. Lactating parents unwilling to travel to UC Davis NICU for study visits
14. Anyone deemed unfit for participation by the investigator(s)

Primary outcomes:
measure: Breast milk calories (kcal/dL) by kangaroo care intervention
timeFrame: 10 days
measure: Breast milk fat (g/dL) by kangaroo care intervention
timeFrame: 10 days
measure: Breast milk protein (g/dL) by kangaroo care intervention
timeFrame: 10 days
measure: Breast milk carbohydrate (g/dL) by kangaroo care intervention
timeFrame: 10 days
measure: Breast milk volume in mL by kangaroo care intervention
timeFrame: 10 days
measure: Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time
timeFrame: 10 days
measure: Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC incomplete
timeFrame: 10 days
measure: Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Parental attitudes
timeFrame: 9 months
measure: Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Provider attitudes
timeFrame: 9 months
Secondary outcomes:
measure: Duration of breast milk provision
timeFrame: 9 months
measure: Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization
timeFrame: 9 months
measure: Infant growth (Birth length and discharge length in cm) during NICU hospitalization
timeFrame: 9 months
measure: Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization
timeFrame: 9 months
measure: Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization
timeFrame: 9 months
measure: Infant growth (Birth length z-score and discharge length z-score) during NICU hospitalization
timeFrame: 9 months
measure: Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization
timeFrame: 9 months
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: UC Davis
state: California
Study officials:
affiliation: UC Davis
name: Kara Kuhn-Riordon, MD
role: PRINCIPAL_INVESTIGATOR
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