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

Primary Purpose

Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Kangaroo Care
No Kangaroo Care
Sponsored by
University of California, Davis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lactation Disorder With Baby Delivered focused on measuring Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: 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: 1. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study. Exclusion Criteria: 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)

Sites / Locations

  • UC Davis

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Kangaroo Care Arm (KC)

Control Arm (CON)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time
Record minutes spent in Kangaroo Care during each study visit
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)
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.
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.

Secondary Outcome Measures

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

Full Information

First Posted
August 1, 2023
Last Updated
September 14, 2023
Sponsor
University of California, Davis
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1. Study Identification

Unique Protocol Identification Number
NCT06047470
Brief Title
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
Acronym
MILK
Official Title
Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, Davis

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lactation Disorder With Baby Delivered, Nutrition Disorder, Infant
Keywords
Lactation, Kangaroo Care, NICU, Breast milk, Nutrition, Skin to skin

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kangaroo Care Arm (KC)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control Arm (CON)
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Kangaroo Care
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
No Kangaroo Care
Intervention Description
Lactating parents will provide a breast milk sample after having no contact with their infant for at least 6 hours.
Primary Outcome Measure Information:
Title
Breast milk calories (kcal/dL) by kangaroo care intervention
Description
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.
Time Frame
10 days
Title
Breast milk fat (g/dL) by kangaroo care intervention
Description
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.
Time Frame
10 days
Title
Breast milk protein (g/dL) by kangaroo care intervention
Description
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.
Time Frame
10 days
Title
Breast milk carbohydrate (g/dL) by kangaroo care intervention
Description
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.
Time Frame
10 days
Title
Breast milk volume in mL by kangaroo care intervention
Description
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.
Time Frame
10 days
Title
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC time
Description
Record minutes spent in Kangaroo Care during each study visit
Time Frame
10 days
Title
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - KC incomplete
Description
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)
Time Frame
10 days
Title
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Parental attitudes
Description
Qualitative survey (via zoom) of parents after study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.
Time Frame
9 months
Title
Implementation of scheduled Kangaroo Care Visits in the UC Davis NICU - Provider attitudes
Description
Qualitative survey (via zoom) of NICU providers after participation in study visit completion to better understand attitudes and experiences with scheduled Kangaroo Care visits.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Duration of breast milk provision
Description
Determine the length of time that breast milk is provided to the infant during the infant's hospital stay.
Time Frame
9 months
Title
Infant growth (Birth weight and discharge weight in grams) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time Frame
9 months
Title
Infant growth (Birth length and discharge length in cm) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time Frame
9 months
Title
Infant growth (Birth head circumference and discharge head circumference in cm) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight and discharge weight
Time Frame
9 months
Title
Infant growth (Birth weight z-score and discharge weight z-score) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
Time Frame
9 months
Title
Infant growth (Birth length z-score and discharge length z-score) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
Time Frame
9 months
Title
Infant growth (Birth head circumference z-score and discharge head circumference z-score) during NICU hospitalization
Description
Examine infant growth during NICU hospitalization, recording the birth weight z-score and discharge weight z-score
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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: 1. Physicians, nurses, fellows, residents, and NICU staff involved in the implementation of Kangaroo care for the MILK study. Exclusion Criteria: 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kara Kuhn-Riordon, MD
Phone
916-703-3050
Email
kmkuhn@ucdavis.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kara Kuhn-Riordon, MD
Organizational Affiliation
UC Davis
Official's Role
Principal Investigator
Facility Information:
Facility Name
UC Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kara Kuhn-Riordon, MD
Phone
916-703-3050
Email
kmkuhn@ucdavis.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Macronutrients in Lactating NICU Parents - Impact of Kangaroo Care

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