Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care (MILK)

September 14, 2023 updated by: University of California, Davis
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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

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

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • UC Davis
        • Contact:

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.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Kangaroo Care Arm (KC)
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
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.
Placebo Comparator: Control Arm (CON)
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
Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Breast milk calories (kcal/dL) by kangaroo care intervention
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 10 days
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
Time Frame: 9 months
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
Time Frame: 9 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of breast milk provision
Time Frame: 9 months
Determine the length of time that breast milk is provided to the infant during the infant's hospital stay.
9 months
Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
9 months
Infant growth (Birth length and discharge length in cm) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
9 months
Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
9 months
Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
9 months
Infant growth (Birth length z-score and discharge length z-score) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
9 months
Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization
Time Frame: 9 months
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, Davis

Investigators

  • Principal Investigator: Kara Kuhn-Riordon, MD, UC Davis

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Estimated)

October 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

June 1, 2024

Study Registration Dates

First Submitted

August 1, 2023

First Submitted That Met QC Criteria

September 14, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1982835

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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