Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care (MILK)

University of California (UC) Davis

Status: Active, not recruiting

Conditions: Nutrition Disorder, Infant; Lactation Disorder With Baby Delivered

Treatments: Behavioral: No Kangaroo Care; Behavioral: Kangaroo Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06047470

1982835

Details and patient eligibility

About

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.

Full 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

Enrollment: 25 estimated patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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25 participants in 2 patient groups, including a placebo group

Kangaroo Care Arm (KC)

Active Comparator group

Description:

Lactating parents will be asked to arrive at the NICU 2 hours after they have fully expressed their breasts at home and to provide their infants with kangaroo care for 1 hour. Following KC and while still at the infant's bedside, lactating parents will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later.

Treatment:

Behavioral: Kangaroo Care

Control Arm (CON)

Placebo Comparator group

Description:

Lactating parents will be asked to arrive at the NICU 3 hours after they have fully expressed their breasts at home. Lactating parents will be taken to a private room where they will be asked to pump from both of their breasts using a hospital grade pump available in the NICU. Study personnel will weigh the collected milk to determine the total volume of milk expressed by mass. The milk collected from both breasts will be gently swirled six times or more until the fat layer is incorporated in the bottle and will be combined into one bottle. Study personnel will take one 6 mL aliquot from the collected milk for compositional analysis. The remainder of the milk will be saved in the NICU per routine so that it can be fed to the infant later. Lactating parents will then provide their infants with kangaroo care for 1 hour.

Treatment:

Behavioral: No Kangaroo Care