Impact of Kangaroo Care on Lactating Parents in the NICU
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
This study is testing if holding a baby skin-to-skin helps breastfeeding parents in the NICU produce more milk and have a better experience during their time there.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 25 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | Female |
| Sponsor | University of California, Davis Academic / other |
| Locations | 1 site (Sacramento, California) |
| Trial ID | NCT06047470 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effects of Kangaroo Care, which involves holding a baby skin-to-skin on the parent's chest, on lactating parents with infants in the Neonatal Intensive Care Unit (NICU) who cannot breastfeed directly. The study aims to assess changes in breast milk volume and macronutrient content, as well as parental experiences and perceptions regarding Kangaroo Care. Participants will attend four scheduled visits at UC Davis NICU over ten days, where they will perform Kangaroo Care and express breast milk for analysis. Additionally, participants will engage in brief interviews to share their experiences.
Who should consider this trial
Good fit: Ideal candidates are lactating parents of infants in the NICU who are expected to remain hospitalized for at least two weeks and plan to provide breast milk.
Not a fit: Patients whose infants are not admitted to the NICU or who do not plan to breastfeed may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance breastfeeding outcomes and parental bonding for NICU infants.
How similar studies have performed: Previous studies have shown positive outcomes with Kangaroo Care in similar settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Sacramento, California
- UC Davis — Sacramento, California, United States (Recruiting)
Study contacts
- Principal investigator: Kara Kuhn-Riordon, MD — UC Davis
- Study coordinator: Kara Kuhn-Riordon, MD
- Email: kmkuhn@ucdavis.edu
- Phone: 916-703-3050
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.