ACTIVE_NOT_RECRUITING

Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Conditions

Lactation Disorder With Baby Delivered Nutrition Disorder, Infant Lactation Kangaroo Care NICU Breast milk Nutrition Skin to skin

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

Quick Facts

Study Start:2023-11-15

Study Completion:2026-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06047470

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
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	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)

Inclusion Criteria

Exclusion Criteria

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

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)

Contacts and Locations

Principal Investigator

Kara Kuhn-Riordon, MD

PRINCIPAL_INVESTIGATOR

UC Davis

Study Locations (Sites)

UC Davis

Sacramento, California, 95817

United States

Collaborators and Investigators

Sponsor: University of California, Davis

Kara Kuhn-Riordon, MD, PRINCIPAL_INVESTIGATOR, UC Davis

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-11-15

Study Completion Date2026-01

Study Record Updates

Study Start Date2023-11-15

Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

Lactation
Kangaroo Care
NICU
Breast milk
Nutrition
Skin to skin

Additional Relevant MeSH Terms

Lactation Disorder With Baby Delivered
Nutrition Disorder, Infant