Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care (MILK)
Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant
About this trial
This is an interventional health services research trial for Lactation Disorder With Baby Delivered focused on measuring Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin
Eligibility Criteria
Inclusion Criteria: 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 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. 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)
Sites / Locations
- UC Davis
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Kangaroo Care Arm (KC)
Control Arm (CON)
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.
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.