This study is in progress, not accepting new patients

Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

a study on Lactation Disorder With Baby Delivered Nutrition Disorder, Infant Breastfeeding

Summary

Eligibility
for females ages 18-100 (full criteria)
Healthy Volunteers
healthy people welcome
Location
at Sacramento, California
Dates
study started
study ends around
Principal Investigator
by Kara Kuhn-Riordon, MD

Description

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.

Details

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

Keywords

Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant, Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin, Infant Nutrition Disorders, Breast Feeding, Kangaroo-Mother Care Method, No Kangaroo Care

Eligibility

You can join if…

Open to females ages 18-100

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.

You CAN'T join if...

  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)

Location

  • UC Davis
    Sacramento California 95817 United States

Lead Scientist at UC Davis

  • Kara Kuhn-Riordon, MD
    Associate Professor of Clinical, MED: Pediatrics, School of Medicine. Authored (or co-authored) 8 research publications

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, Davis
ID
NCT06047470
Study Type
Interventional
Participants
Expecting 25 study participants
Last Updated