Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

NCT06047470 | Active Not Recruiting

• 1 other identifier: 1982835
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nutrition Disorder, Infant; Lactation Disorder With Baby Delivered

Keywords

Lactation; Kangaroo Care; NICU; Breast milk; Nutrition; Skin to skin

Outcome Measures

Primary Outcomes (9)

• Breast milk calories (kcal/dL) by kangaroo care intervention

  The difference in expressed breast milk caloric composition/energy content) between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.

  10 days

• Breast milk fat (g/dL) by kangaroo care intervention

  The difference in expressed breast milk fat content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.

  10 days

• Breast milk protein (g/dL) by kangaroo care intervention

  The difference in expressed breast milk protein content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.

  10 days

• Breast milk carbohydrate (g/dL) by kangaroo care intervention

  The difference in expressed breast milk carbohydrate content between samples collected after participating in kangaroo care and those collected after having no contact with the infant for at least 6 hours.

  10 days

• Breast milk volume in mL by kangaroo care intervention

  The difference in expressed breast milk volume expression between samples collected after participating in kangaroo care and after having no contact with the infant for at least 6 hours.

  10 days

• Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time

  Record minutes spent in Kangaroo Care during each study visit

  10 days

• Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC incomplete

  Record reasons for KC visits lasting less than 60 minutes - including infant causes (clinical instability, intolerance, technical issues with equipment) and parental causes (parental discomfort/anxiety, parental scheduling conflict, need to use restroom/express breast milk)

  10 days

• Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Parental attitudes

  Qualitative survey (via zoom) of parents after study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.

  9 months

• Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Provider attitudes

  Qualitative survey (via zoom) of NICU providers after participation in study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.

  9 months

Secondary Outcomes (7)

• Duration of breast milk provision

  9 months

• Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization

  9 months

• Infant growth (Birth length and discharge length in cm) during NICU hospitalization

  9 months

• Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization

  9 months

• Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization

  9 months

Study Arms (2)

Kangaroo Care Arm (KC)

ACTIVE COMPARATOR

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.

Behavioral: Kangaroo Care

Control Arm (CON)

PLACEBO COMPARATOR

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.

Behavioral: No Kangaroo Care

Interventions

Kangaroo Care BEHAVIORAL

Lactating parents will participate in kangaroo care (holding an infant upright, directly on the chest with skin-to-skin contact) prior to expressing a breast milk sample.

Kangaroo Care Arm (KC)

No Kangaroo Care BEHAVIORAL

Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.

Control Arm (CON)

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• \. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

UC Davis

Sacramento, California, 95817, United States

Location

Related Publications (18)

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  PMID: 12517197 BACKGROUND

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  PMID: 8506163 BACKGROUND

• Health WHOR, Organization WH, UNAIDS. Kangaroo Mother Care: A Practical Guide. World Health Organization; 2003.

  BACKGROUND

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• Coskun D, Gunay U. The Effects of Kangaroo Care Applied by Turkish Mothers who Have Premature Babies and Cannot Breastfeed on Their Stress Levels and Amount of Milk Production. J Pediatr Nurs. 2020 Jan-Feb;50:e26-e32. doi: 10.1016/j.pedn.2019.09.028. Epub 2019 Oct 28.

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MeSH Terms

Conditions

Infant Nutrition Disorders; Breast Feeding

Interventions

Kangaroo-Mother Care Method

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Feeding Behavior; Behavior

Intervention Hierarchy (Ancestors)

Patient Positioning; Patient Care; Therapeutics; Infant Care; Child Care; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kara Kuhn-Riordon, MD

  UC Davis

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study is a mixed methods study comprising of a randomized, crossover interventional trial of Kangaroo Care vs Control and milk expression, study of implementation of scheduled Kangaroo Care in the UC Davis NICU, and qualitative interviews of providers and parents to understand their attitudes and experiences with Kangaroo Care.

Study Record Dates

• First Submitted: August 1, 2023
• First Posted: September 21, 2023
• Study Start: November 15, 2023
• Primary Completion: May 26, 2025
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)